scholarly journals Deltoid-Spring Ligament Reconstruction in Stage IIB Adult Acquired Flatfoot Deformity with Spring Ligament Tear

2018 ◽  
Vol 3 (3) ◽  
pp. 2473011418S0037
Author(s):  
Irvin Oh ◽  
Ashlee MacDonald ◽  
Tochukwu Ikepeze ◽  
Jonathan Deland

Category: Hindfoot Introduction/Purpose: Spring ligament tear is often present in advanced stages of the Adult Acquired Flatfoot Deformity (AAFD). Previous anatomic studies have demonstrated that the superficial deltoid ligament blends with the superomedial spring ligament to provide both medial tibiotalar and talonavicular stability. They form a large confluent ligament, the tibiocalcaneonavicular ligament, (TCNL) which is the most consistently found component of the deltoid ligament. For surgical reconstruction of advanced stage AAFD with large spring ligament tears, adding allograft TCNL reconstruction to osseous correction has suggested to augment medial peritalar stability. We aimed to investigate the clinical and radiographic outcomes of the novel TCNL reconstruction for stage IIB AAFD with spring ligament tear. Methods: Twelve feet in 11 patients (7 female, 4 male, mean age 56.1 years) who underwent osseous correction and TCNL reconstruction for stage IIB AAFD were employed. TCNL reconstruction was indicated in the presence of large spring ligament tears (1.5-3 cm) and when inadequate reduction remained after osseous corrections. All 12 feet underwent gastrocnemius recession, medializing calcaneal osteotomy, lateral column lengthening and Cotton or Lapidus procedures. Bone tunnels were made in the tibia (7 mm), sustetaculum tali (6 mm) and navicular (6 mm) for tendon allograft passage for TCNL reconstruction (Figure 1). Subjects were evaluated at mean of 24 months (range, 12-33 months) after surgery. Pre- and post-operative clinical outcomes were assessed by administrating FAAM_ADL, SF-36 PF and Pain, Patient Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) and Pain Interference (PI) domains using Computerized Adaptive Testing. Correction of forefoot abduction and sagittal arch were measured from weight bearing radiographs of the foot. Results: The FAAM_ADL improved from 69.3 to 90.1 (p = 0.001). SF-36 PF and Pain subscales both improved significantly (39.4 to 87.8, 44.6 to 93.1, respectively, p <0.001 for each). PROMIS PF improved from 38.2 to 46.8 (p = 0.002) and PI 62.6 to 50.1 (p = 0.003). All but one patient were satisfied with the result. Radiographic measures showed improved AP talo-first metatarsal angle of 24.7° to 11.8° (p < 0.001) and talonavicular coverage angle of 47.4° to 23.1° (p <0.01). The talar head uncoverage improved from 56.1% to 32.5% (p < 0.01). Improved Meary’s angle of 29.7° to 12.5° (P < 0.001) and calcaneal pitch angle of 11.7° to 16.9° (p = 0.14) were noted in the lateral view. Conclusion: The current study demonstrates that TCNL reconstruction is a viable surgical treatment option for augmentation of medial peritalar stability in advanced stage AAFD with spring ligament tear. This is the first short term clinical investigation to report the clinical and radiographic outcomes of the novel TCNL reconstruction. Considering the anatomic characteristic of the deltoid-spring ligament complex, the TCNL reconstruction may play a significant role in maintaining surgical correction of deformity.

2019 ◽  
Vol 40 (7) ◽  
pp. 753-761 ◽  
Author(s):  
James D. Brodell ◽  
Ashlee MacDonald ◽  
James A. Perkins ◽  
Jonathan T. Deland ◽  
Irvin Oh

Background: A spring ligament tear is commonly present in advanced stages of adult acquired flatfoot deformity (AAFD). Previous anatomic studies have demonstrated that the superficial deltoid ligament blends with the superomedial spring ligament, forming the tibiocalcaneonavicular ligament (TCNL). Adding allograft TCNL reconstruction to osseous correction has been suggested to augment medial peritalar stability in advanced AAFD with large spring ligament tears. We aimed to investigate the clinical and radiographic outcomes of TCNL reconstruction for flexible AAFD with medial peritalar instability. Methods: Fourteen feet in 12 patients who underwent osseous and TCNL reconstructions for advanced AAFD (stage IIB with large spring ligament tears or stage IV) were recruited for the study. The mean postoperative follow-up was 24 (range, 12-33) months. Pre- and postoperative clinical outcomes were assessed by the Foot and Ankle Ability Measure (FAAM), SF-36, and Patient-Reported Outcomes Measurement Information System (PROMIS). Correction of forefoot abduction and the sagittal arch were measured from pre- and postoperative weightbearing radiographs. Results: The FAAM Activities of Daily Living improved from 69.3 to 90.1 ( P = .001). The SF-36 Physical Function (PF) and Pain subscales both improved significantly (39.4 to 87.8 and 44.6 to 93.1, respectively, P < .001 for each). The PROMIS PF improved from 38.2 to 46.8 ( P = .002) and the PROMIS Pain Interference (PI) from 62.6 to 50.1 ( P = .003). Radiographic measures showed an improved anterior-posterior (AP) talo–first metatarsal angle of 24.7 to 11.8 degrees ( P < .001) and talonavicular coverage angle of 47.4 to 23.1 degrees ( P < .01). An improved Meary’s angle of 29.7 to 12.5 degrees ( P < .001) and a calcaneal pitch angle of 11.7 to 16.9 degrees ( P = .14) were noted in the lateral view. Conclusion: Considering the anatomic characteristics of the deltoid-spring ligament complex, TCNL reconstruction may play a significant role in maintaining peritalar stability when performed with osseous correction. Deltoid-spring ligament (TCNL) reconstruction is a viable surgical option for those with advanced stage AAFD with medial peritalar instability that leads to improved functional and radiographic outcomes. Level of Evidence: Level IV, retrospective case series.


2018 ◽  
Vol 3 (3) ◽  
pp. 2473011418S0032
Author(s):  
Ashlee MacDonald ◽  
David Ciufo ◽  
Emma Knapp ◽  
Hani Awad ◽  
John Ketz ◽  
...  

Category: Hindfoot Introduction/Purpose: Spring ligament tear is often present in advanced stages of the AAFD. Anatomic studies have demonstrated that the superficial deltoid ligament blends with the superomedial spring ligament to provide medial tibiotalar and talonavicular stability. Reconstruction of combined deltoid-spring ligament, or the Tibiocalcaneonvaicular ligament (TCNL) was proposed to augment medial stability in advanced AAFD with large spring ligament tears. A tendon allograft is placed to cross three peritalar (tibiotalar, talonavicular and subtalar) joints to augment medial stability. We aimed to 1) investigate the kinematic effects of TCNL reconstruction in cadaveric flatfoot model with medial ligament insufficiency, and 2) compare TCNL reconstruction with anatomic spring and anatomic deltoid ligament reconstructions (Figure 1). We hypothesized that TCNL reconstruction is effective in restoring peritalar kinematics. Methods: Five fresh-frozen cadaveric foot specimens were employed. Advanced stage flatfoot model was created by sectioning the medial and inferior talonavicular interosseous ligament and extending the release 2 cm proximally along the superomedial spring ligament. Cyclic axial load of 1150 N under a hydraulic loading frame with constant 350 N Achilles tendon load were applied until >15° talo-first metatarsal abduction was achieved. Bone tunnels were drilled for three reconstruction types, and the peroneus longus tendon was configured to reconstruct the 1) anatomic spring ligament, 2) anatomic deltoid ligament, and 3) TCNL. Reflective markers were mounted on the tibia, talus, navicula, calcaneus and first metatarsus. Each reconstruction type was loaded with 800 N ground reaction force, and kinematics of the peritalar joints were captured by 4-camera motion capture system. Forefoot abduction angle, Meary’s angle, and hindfoot valgus were calculated and compared to the severe flatfoot prior to reconstruction and to each using two-way ANOVA. Results: In creating the flatfoot deformity, both the tibiotalar and subtalar joints demonstrated an increase in valgus deformity by 5.6+3.7° and 6.1+5.3°, respectively, compared to the initial measurements. When comparing to the flatfoot deformity, the TCNL reconstruction achieved a significant improvement in percent correction of total hindfoot valgus (59.7+21.1%, p=0.017) and forefoot abduction angle (83.4+17.7%, p<0.01). The spring ligament reconstruction also demonstrated a significant improvement in forefoot abduction correction compared to the flatfoot (52+10.6%, p<0.05). No other reconstruction technique achieved a statistically significant improvement in percent correction compared to the flatfoot model in forefoot or hindfoot alignments. Additionally, no statistical differences were noted in the percent correction when comparing the three reconstructive techniques to each other. Conclusion: In advanced stage cadaveric flatfoot with spring ligament tear, we found increased valgus alignment at both the tibiotalar and subtalar joints. This kinematic changes reflects increased strain across the medial peritalar ligaments. The deltoid-spring ligament complex (TCNL) reconstruction demonstrated significantly improved alignment of hindfoot valgus and forefoot abduction compared to the severe flatfoot condition. This finding suggests that in addition to osseous correction and tendon transfer, the TCNL reconstruction may serve as an important component in augmenting medial stability in advanced AAFD with medial ligament insufficiency.


2020 ◽  
Vol 5 (4) ◽  
pp. 2473011420S0036
Author(s):  
Rusheel Nayak ◽  
Milap Patel ◽  
Anish R. Kadakia

Category: Hindfoot; Ankle; Midfoot/Forefoot Introduction/Purpose: The tibiocalcaneonavicular ligament (TCNL) is formed from the confluence of the superficial deltoid ligament and the superomedial spring ligament. In advanced flexible adult acquired flatfoot deformity (AAFD), progressive strain on the TCNL can lead to spring ligament tears, deltoid insufficiency, and eventual medial peritalar instability. Historically, medial peritalar instability was corrected using calcaneal osteotomy in conjunction with isolated spring or deltoid reconstruction. A recent study (Brodell et al.) demonstrated the efficacy of TCNL reconstruction in patients with medial peritalar instability. The purpose of this study is to add to this literature using patient-reported and radiographic outcomes in patients undergoing TCNL reconstruction. Patient-reported outcomes were collected using Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) and Pain Interference (PI) surveys. Methods: Sixteen patients (mean age 50.25 years; 11 female, 5 male) who underwent TCNL reconstruction were prospectively identified. TCNL reconstruction was indicated for stage IIB patients (n=13) with large spring ligament tears (>1.5cm on MRI or intraoperatively) or if osseous correction did not provide adequate talonavicular joint correction. TCNL reconstruction was indicated in stage IV patients (n=3) if deltoid reconstruction required additional medial stabilization. No patients underwent lateral column lengthening osteotomies. PROMIS scores were obtained at baseline and at minimum 12-months follow-up (average 16 months). Surgical success was determined using minimum clinically important differences (MCID), defined as improvement greater than one-half the standard deviation of each pre-operative PROMIS domain (PF: +2.9 and PI: -2.5). Pre- and post-operative radiographic parameters were measured: talonavicular uncoverage angle, talonavicular uncoverage percentage, AP talo-first metatarsal angle, Meary’s angle, and medial cuneiform height (MCH). Correlation coefficients determined the relationship between radiographic parameters and PROMIS scores. Results: PROMIS PF scores improved significantly from 38.1+-5.8 to 44.1+-7.1 (p=0.0087). PROMIS PI scores improved significantly from 62.9+-5.1 to 52.3+-8.9 (p=0.0025). Seventy-nine and 77 percent of patients had successful surgeries, as defined by MCIDs in the PROMIS PF and PI domains, respectively. Talonavicular uncoverage percentage and Meary’s angle improved significantly from 34.4+-13.4 to 26.3+-9.9 percent (p=0.0360) and 19.2+-8.8 to 15.3+-6.2 degrees (p=0.0089), respectively. Talonavicular uncoverage angle improved from 29.3+-9.6 to 23.3+-8.0 degrees (p=0.0562), AP talo-first metatarsal angle improved from 15.2+-10.2 to 10.4+-9.0 degrees (p=0.0555), and MCH improved from 13.5+-6.2 to 15.9+-4.8 millimeters (p=0.1374). Post- operative MCH correlated significantly with post-operative PROMIS PF scores (r=0.5941; p=0.0152). Change in AP talo-first metatarsal angle correlated significantly with change in PROMIS PI scores (r=0.5682; p=0.0427). No other correlations were significant. Conclusion: Patients with stage IIB and stage IV AAFD who undergo TCNL reconstructions have excellent patient-reported and radiographic outcomes. Reconstruction of the medial longitudinal arch, as measured by post-operative MCH, is associated with higher post-operative functionality. Surgical correction of midfoot abduction, as measured by change in the AP talo-first metatarsal angle after surgery, is associated with improvements in pain. In patients with medial peritalar instability, TCNL reconstruction can be a valuable technique to correct the sagittal arch, prevent excessive midfoot abduction, and improve pain and functionality.


2020 ◽  
Vol 41 (9) ◽  
pp. 1149-1157
Author(s):  
Ashlee MacDonald ◽  
David Ciufo ◽  
Eric Vess ◽  
Emma Knapp ◽  
Hani A. Awad ◽  
...  

Background: Adult acquired flatfoot deformity (AAFD) is a complex and progressive deformity involving the ligamentous structures of the medial peritalar joints. Recent anatomic studies demonstrated that the spring and deltoid ligaments form a greater medial ligament complex, the tibiocalcaneonavicular ligament (TCNL), which provides medial stability to the talonavicular, subtalar, and tibiotalar joints. The aim of this study was to assess the biomechanical effect of a spring ligament tear on the peritalar stability. The secondary aim was to assess the effect of TCNL reconstruction in restoration of peritalar stability in comparison with other medial stabilization procedures, anatomic spring or deltoid ligament reconstructions, in a cadaveric flatfoot model. Methods: Ten fresh-frozen cadaveric foot specimens were used. Reflective markers were mounted on the tibia, talus, navicular, calcaneus, and first metatarsal. Peritalar joint kinematics were captured by a multiple-camera motion capture system. Mild, moderate, and severe flatfoot models were created by sequential sectioning of medial capsuloligament complex followed by cyclic axial loading. Spring only, deltoid only, and combined deltoid-spring ligament (TCNL) reconstructions were performed. The relative kinematic changes were compared using 2-way analysis of variance (ANOVA). Results: Compared with the initial condition, we noted significantly increased valgus alignment of the subtalar joint of 5.1 ± 2.3 degrees ( P = .031) and 5.8 ± 2.7 degrees ( P < .01) with increased size of the spring ligament tear to create moderate to severe flatfoot, respectively. We noted an increased tibiotalar valgus angle of 5.1 ± 2.0 degrees ( P = .03) in the severe model. Although all medial ligament reconstruction methods were able to correct forefoot abduction, the TCNL reconstruction was able to correct both the subtalar and tibiotalar valgus deformity ( P = .04 and P = .02, respectively). Conclusion: The TCNL complex provided stability to the talonavicular, subtalar, and tibiotalar joints. The combined deltoid-spring ligament (TCNL) reconstructions restored peritalar kinematics better than isolated spring or deltoid ligament reconstruction in the severe AAFD model. Clinical Relevance: The combined deltoid-spring ligament (TCNL) reconstruction maybe considered in advanced AAFD with medial peritalar instability: stage IIB with a large spring ligament tear or stage IV.


Foot & Ankle ◽  
1992 ◽  
Vol 13 (6) ◽  
pp. 327-332 ◽  
Author(s):  
Jonathan T. Deland ◽  
Stephen P. Arnoczky ◽  
Francesca M. Thompson

The mobile unilateral flatfoot deformity of chronic posterior tibial tendon insufficiency has been difficult to correct by soft tissue procedures. The procedures can decrease pain, but they do not always correct the longitudinal arch or relieve all the symptoms. Using 10 fresh frozen cadaveric specimens and a rig for stimulation of weightbearing, the deformity associated with chronic posterior tibial tendon insufficiency was produced by multiple ligamentous release and documented by AP and lateral radiographs. Reconstruction of the spring ligament using a ligament bone autograft from the superficial deltoid ligament was then performed and tested under load. The mean correction was within 2.5° of normal (over or undercorrection) on both the AP and lateral radiographs with the specimens under load. Clinical Relevance. In posterior tibial tendon insufficiency, it may be possible to address the ligament as well as tendon insufficiency to gain a corrected arch. The success of such a procedure will depend upon adequate tendon and ligament reconstruction in a fully mobile deformity. Questions remain as to the adequacy of this ligament graft, and a stronger free ligament graft, as well as correction of any bony malalignment, may be required.


2018 ◽  
Vol 3 (3) ◽  
pp. 2473011418S0032 ◽  
Author(s):  
Ashlee MacDonald ◽  
David Cifo ◽  
Emma Knapp ◽  
Hani Awad ◽  
John Ketz ◽  
...  

Category: Hindfoot Introduction/Purpose: Adult Acquired Flatfoot Deformity (AAFD) is a complex and progressive deformity characterized by abduction of the midfoot and valgus alignment of the hindfoot. Spring ligament tear is often present in advanced stages of the AAFD. Previous anatomic studies have demonstrated that the superficial deltoid ligament blends with the superomedial spring ligament to provide both medial tibiotalar and talonavicular stability aiding in coronal plane stability. Given that the spring ligament blends with the superficial deltoid ligament, we sought to investigate the kinematic effect of spring ligament tear in development of peritalar instability in cadaveric flatfoot model. We hypothesized that increased spring ligament tear size will result in increased talonavicular joint abduction (axial) and plantarflexion (sagittal), and increased valgus alignment of the tibiotalar and subtalar joints (coronal). Methods: Seven fresh-frozen cadaveric foot specimens were employed. Reflective markers were mounted on the tibia, talus, navicula, calcaneus and the first metatarsus. Kinematics of the peritalar joints were captured by multiple camera motion capture system. A flatfoot model was created by sectioning the medial and inferior talonavicular interosseous ligament, followed by cyclic axial load of 1150 N under a hydraulic loading frame with 350 N load applied to the Achilles tendon. The talo-first metatarsus (T- 1MT) abduction angle was calculated and cycles were applied until abduction of 5-10° (mild flatfoot) was achieved. Spring ligament sectioning was extended 1 cm proximally along the superomedial ligament followed by cyclic loading until 10-15° (moderate) of T- 1MT abduction was achieved. The spring ligament was sectioned for another 1 cm followed by cyclic loading until >15° (severe) abduction was noted. The relative kinematic changes were compared among the initial, mild, moderate, and severe flatfoot model using two-way ANOVA. Results: The average T-1MT abduction angles in the mild, moderate, and severe flatfoot were 7.79°+/-2.27°, 11.47°+/-2.82°, and 15.46°+4.15°. Meary’s angle increased with progression of the flatfoot (mild 6.17°+/-2.92°, moderate 9.71°+/-3.4°, severe 12.46°+/-4.13°). Hindfoot valgus angle also increased. The mild, moderate, and severe flatfoot showed 2.4°+/-3.85°, 4.13°+/-3.9°, and 4.75°+/-3.79° of tibiotalar valgus angle. The subtalar joint exhibited 2.94°+/-3.41°, 5.52°+/-4.34°, and 6.97°+/-4.83° valgus angle in the mild, moderate, and severe models. The T-1MT abduction angle and Meary’s angle were significantly different in all flatfoot models compared to the initial condition (p<0.001), and the severe vs. mild models (p<0.01). Tibiotalar valgus was significantly increased in severe compared to the initial model (p=0.02). Subtalar valgus angle significantly increased in the moderate and severe models compared to the initial (p<0.01, p<0.001). Conclusion: Serial increment in spring ligament tear size in simulated flatfoot increased relative talus adduction and plantarflexion. It also resulted in gradual increment of valgus alignment of the tibiotalar and subtalar joints in coronal plane. This finding demonstrates that a large spring ligament tear in advanced stage AAFD leads to increased strain across the medial peritalar ligaments. In addition to osseous correction and tendon transfer, medial ligament augmentation, may be a critical component in surgical correction of AAFD with a large spring ligament tear.


2018 ◽  
Vol 25 (13) ◽  
pp. 1791-1799 ◽  
Author(s):  
Brian C Healy ◽  
Jonathan Zurawski ◽  
Cindy T Gonzalez ◽  
Tanuja Chitnis ◽  
Howard L Weiner ◽  
...  

Background: To date, the computerized adaptive testing (CAT) version of the Neuro-quality of life (QOL) has not been assessed in a large sample of people with multiple sclerosis (MS). Objective: The aim of this study was to assess the associations between the CAT version of Neuro-QOL and other clinical and patient-reported outcome measures. Methods: Subjects ( n = 364) enrolled in SysteMS completed the CAT version of the Neuro-QOL and the 36-Item Short Form Survey (SF-36) within 4 weeks of a clinical exam that included the Multiple Sclerosis Functional Composite-4 (MSFC-4). The correlations between the Neuro-QOL domains and the MSFC-4 subscores and the SF-36 scores were calculated. The changes over time in the Neuro-QOL and other measures were also examined. Results: The lower extremity functioning score of the Neuro-QOL showed the highest correlations with MSFC-4 components including Timed 25-Foot Walk, 9-Hole Peg Test, and cognitive score. The expected domains of the Neuro-QOL showed high correlations with the SF-36 subscores, and some Neuro-QOL domains were associated with many SF-36 subscores. There was limited longitudinal change on the Neuro-QOL domains over 12 months, and the change was not associated with change on other measures. Conclusion: The CAT version of the Neuro-QOL shows many of the expected associations with clinical and patient-reported outcome measures.


2018 ◽  
Vol 39 (4) ◽  
pp. 433-442 ◽  
Author(s):  
Alessio Bernasconi ◽  
Francesco Sadile ◽  
Matthew Welck ◽  
Nazim Mehdi ◽  
Julien Laborde ◽  
...  

Background: Stage II tibialis posterior tendon dysfunction (PTTD) resistant to conservative therapies is usually treated with invasive surgery. Posterior tibial tendoscopy is a novel technique being used in the assessment and treatment of posterior tibial pathology. The aims of this study were (1) to clarify the role of posterior tibial tendon tendoscopy in treating stage II PTTD, (2) to arthroscopically classify spring ligament lesions, and (3) to compare the arthroscopic assessment of spring ligament lesions with magnetic resonance imaging (MRI) and ultrasonographic (US) data. Methods: We reviewed prospectively collected data on 16 patients affected by stage II PTTD and treated by tendoscopy. We report the reoperation rate and functional outcomes evaluated by comparing pre- and postoperative visual analogic scale for pain (VAS-pain) and the Short-Form Health Survey (SF-36; with its physical [PCS] and mental [MCS] components). Postoperative satisfaction was assessed using a VAS-satisfaction scale. One patient was lost to follow-up. Spring ligament lesions were arthroscopically classified in 3 stages. Discrepancies between preoperative imaging and intraoperative findings were evaluated. Results: At a mean of 25.6 months’ follow-up, VAS-pain ( P < .001), SF-36 PCS ( P = .039), and SF-36 MCS ( P < .001) significantly improved. The mean VAS-satisfaction score was 75.3/100. Patients were relieved from symptoms in 80% of cases, while 3 patients required further surgery. MRI and US were in agreement with intraoperative data in 92% and 67%, respectively, for the tendon assessment and in 78% and 42%, respectively, for the spring ligament. Conclusions: Tendoscopy may be considered a valid therapeutic tool in the treatment of stage II PTTD resistant to conservative treatment. It provided objective and subjective encouraging results that could allow continued conservative therapy while avoiding more invasive surgery in most cases. MRI and US were proven more useful in detecting PT lesions than spring ligament tears. Further studies on PT could use this tendoscopic classification to standardize its description. Level of Evidence: Level IV, therapeutic study, case series.


2019 ◽  
Vol 4 (4) ◽  
pp. 2473011419S0041
Author(s):  
Derek S. Stenquist ◽  
Brian Velasco ◽  
Patrick K. Cronin ◽  
Jorge Briceno ◽  
Christopher Miller ◽  
...  

Category: Ankle Introduction/Purpose: Syndesmotic disruption occurs in nearly 1 in 5 ankle fractures and requires anatomic reduction and internal stabilization to maximize functional outcomes. There is growing evidence to support retaining syndesmotic hardware from both a functional and economic standpoint. However, although broken screws are typically of little consequence, the location of screw breakage can be unpredictable and cause painful bony erosion and difficulty with extraction. The purpose of this investigation is to report early clinical and radiographic outcomes of patients who underwent syndesmotic fixation using a novel metal screw with a more predictable break point and design features to allow for easier extraction. Methods: We performed a retrospective review of all consecutive patients who underwent syndesmotic fixation utilizing the novel syndesmotic screw over a one year period. Demographic data were obtained such as age, gender, fracture classification and relevant comorbidities. Screw specific data were obtained such as number of screws utilized and length. Screw loosening or breakage was documented. Postoperative radiographs were reviewed and tibiofibular overlap, tibiofibular clear space and medial clear space were measured. Results: 18 patients met inclusion criteria. Mean length of clinical follow-up was 4.67 months (range 0.5 to 8.5 months). Per the Lauge Hansen classification, 14 injuries were supination external rotation type, two were pronation abduction and two pronation external rotation type. Three screws (12.5%) fractured at the break point with no screws fracturing at a different location. 21 screws did not fracture with 10 (42%) of the screws demonstrated to be loose. There was no evidence of syndesmotic diastasis or mortise malalignment on final follow up of the cohort. No screws required removal during the study period. There were no other complications of any type (Table 1). Conclusion: Early reporting of outcomes is essential to maximize both safety and value in healthcare technology innovation. This study provides the first clinical data on a novel alternative to traditional screws and suture button devices for fixation of syndesmotic injuries. At short-term follow up, there were no complications and the novel screw provided adequate fixation to allow healing and prevent diastasis. While initial results are favorable, longer term follow-up is required to determine whether this novel implant can reduce rates of symptomatic hardware requiring removal, which could ultimately make them more cost- effective than suture-button fixation.


2011 ◽  
Vol 38 (8) ◽  
pp. 1759-1764 ◽  
Author(s):  
JAMES FRIES ◽  
MATTHIAS ROSE ◽  
ESWAR KRISHNAN

Objective.Use of item response theory (IRT) and, subsequently, computerized adaptive testing (CAT), under the umbrella of the NIH-PROMIS initiative (National Institutes of Health – Patient-Reported Outcomes Measurement Information System), to bring strong new assets to the development of more sensitive, more widely applicable, and more efficiently administered patient-reported outcome (PRO) instruments. We present data on current progress in 3 crucial areas: floor and ceiling effects, responsiveness to change, and interactive computer-based administration over the Internet.Methods.We examined nearly 1000 patients with rheumatoid arthritis and related diseases in a series of studies including a one-year longitudinal examination of detection of change; compared responsiveness of the Legacy SF-36 and HAQ-DI instruments with IRT-based instruments; performed a randomized head-to-head trial of 4 modes of item administration; and simulated the effect of lack of floor and ceiling items upon statistical power and sample sizes.Results.IRT-based PROMIS instruments are more sensitive to change, resulting in the potential to reduce sample size requirements substantially by up to a factor of 4. The modes of administration tested did not differ from each other in any instance by more than one-tenth of a standard deviation. Floor and ceiling effects greatly reduce the number of available subjects, particularly at the ceiling.Conclusion.Failure to adequately address floor and ceiling effects, which determine the range of an instrument, can result in suboptimal assessment of many patients. Improved items, improved instruments, and computer-based administration improve PRO assessment and represent a fundamental advance in clinical outcomes research.


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