scholarly journals Clinical Outcomes and PROMIS Scores with the Use of Synthetic Cartilage Implant (CARTIVA) in Hallux Rigidus at a Non-Industry Sponsored, Multi-Surgeon, Academic Institution

2019 ◽  
Vol 4 (4) ◽  
pp. 2473011419S0013
Author(s):  
Megan C. Chapter ◽  
Jonathan H. Garfinkel ◽  
Taylor Cabe ◽  
Scott Ellis ◽  
Matthew Roberts ◽  
...  
Keyword(s):  
Physical Function ◽  
Clinical Outcomes ◽  
Hallux Rigidus ◽  
Academic Institution ◽  
Foot And Ankle ◽  
Global Function ◽  
One Year ◽  
Radiographic Grading ◽  
Pva Hydrogel

Category: Midfoot/Forefoot Introduction/Purpose: Hallux rigidus is a common arthritic condition seen by foot and ankle specialists. Historically, surgical treatment options have varied from an isolated cheilectomy to first metatarsophalangeal joint fusion. More recently, first metatarsophalangeal (MTP) joint hemiarthroplasty with a polyvinyl alcohol (PVA) hydrogel implant (Cartiva) has become a popular surgical option. A randomized clinical trial sponsored by the manufacturers of the implant showed equivalent pain relief and functional outcome scores at 2 year follow-up when compared to patients undergoing first MTP fusion. In addition, the study reported no bone loss, implant wear or loosening. We retrospectively reviewed 1 year PROMIS score outcomes, clinical outcomes and implant survivorship of patients treated with first MTP hemiarthroplasty with the Cartiva implant at an academic, multi-surgeon center. Methods: We retrospectively reviewed 54 consecutive patients that underwent first MTP hemiarthroplasty with Cartiva for hallux rigidus between January 1, 2017 and December 1, 2017. Minimum follow-up criteria was 1 year, with the average being 1.37 years and maximum follow-up of 1.9 years. The Coughlin radiographic grading of disease severity averaged 2.18 at the time of implantation on a scale of 0 to 4. Surgery was performed by 8 fellowship-trained orthopedic foot and ankle surgeons at an academic institution. Baseline PROMIS scores (physical function, pain interference, global function, global mental, depression) and PROMIS scores acquired at 1 year postoperative were compared and evaluated using the Wilcoxon signed t-test. Clinical outcomes and postoperative complications/events were documented through review of electronic medical records. At the time of the study, 49 patients had reached 1 year follow-up with an average age of 56 (range, 33 - 74) years at the time of implantation. Results: Physical function, pain interference, global function and depression scores all demonstrated clinically and statistically significant improvement at 1 year postoperative. Global mental score did not show significant improvement at the one year follow-up. One patient underwent revision surgery to a 1st MTP fusion for persistent pain. Three patients had postoperative soft tissue swelling requiring prolonged retained sutures. Five patients underwent therapeutic injection with steroid between 2 - 11 months postoperative for persistent discomfort which improved. Five patients were prescribed orthotics between 3 - 6 months follow-up. One patient sustained a metatarsal fracture during the application of the implant requiring ORIF but retained the implant. Implant retention at 1 year was 98% (48/49). No correlation between preoperative radiographic grading and the incidence of poor clinical outcomes. Conclusion: To our knowledge, this is the first study that demonstrates the outcomes of synthetic cartilage implants using a large series of surgeons without affiliation or consultation for the implant company. One year following first MTP hemiarthroplasty with PVA hydrogel implant (Cartiva), functional and pain scores improved significantly, but did not show significant improvement with global mental scores. The implant displayed excellent survivorship at the 1 year time point, with only one patient undergoing surgical revision. Treatment of hallux rigidus with the PVA hydrogel implant - Cartiva, shows improved patient outcomes and has reassuring results at one year.

scholarly journals Postoperative Outcomes and Complications in Hallux Rigidus: A Comparison Between Polyvinyl Alcohol Implant and Cheilectomy with Moberg Osteotomy

2020 ◽  
Vol 5 (4) ◽  
pp. 2473011420S0017
Author(s):  
Bopha Chrea ◽  
Jonathan Day ◽  
Stephanie K. Eble ◽  
Megan Reilly ◽  
Jonathan T. Deland ◽  
...  
Keyword(s):  
Surgical Treatment ◽  
Polyvinyl Alcohol ◽  
Physical Function ◽  
Clinical Outcomes ◽  
Patient Reported Outcomes ◽  
Hallux Rigidus ◽  
Study Cohort ◽  
Proper Patient Selection ◽  
Patient Reported

Category: Midfoot/Forefoot; Other Introduction/Purpose: In 2016, the US Food and Drug Administration (FDA) approved the use of a polvinvyl alcohol (PVA) hydrogel implant (Cartiva, Elmsford, NY) for surgical treatment of hallux rigidus, or degenerative arthritis of the first metatarsophalangeal (1st MTP) joint. While studies have demonstrated the safety and usability of PVA implant, clinical outcomes following hemiarthroplasty with the PVA have not yet been compared to that of traditional joint-preserving procedures such as cheilectomy with Moberg osteotomy in the treatment of hallux rigidus. The purpose of this study is to compare patient-reported outcomes and postoperative complications between PVA hemiarthroplasty and cheilectomy with Moberg osteotomy, with the hypothesis that the addition of PVA would result in superior clinical outcomes. Methods: Patients were retrospectively identified who underwent hallux rigidus correction by one of seven Foot and Ankle fellowship-trained orthopaedic surgeons between March 2016 and November 2018. Out of 162 patients, a total of 133 patients constituted our study cohort after excluding patients with insufficient follow-up. Of the 133, 60 patients (mean age 57.2 years) were treated with combination PVA, cheilectomy, and Moberg osteotomy (PCM) and 73 patients (mean age 54.1) were treated with cheilectomy and Moberg (CM) alone. Both preoperative as well as minimum 1-year postoperative patient-reported outcome scores (PROMIS) were compared between the two cohorts. Chart review was performed to compare rates of revision and complications. Results: Average time to follow-up was 14.5 months for PCM and 15.6 for CM groups. Both PCM and CM cohorts demonstrated significant improvement in PROMIS scores, with the CM group demonstrating significantly greater increase in Physical Function (7.14 +- 8.48 vs 3.58 +- 6.24, p=0.01). While preoperative scores were comparable, postoperatively the CM group had a significantly higher average Physical Function (51.8 +- 8.7 vs 48.8 +- 8.0, p=0.04) and lower Pain Intensity (39.9 +- 8.3 vs 43.4 +- 8.7, p=0.02). There were 2 cases of revision with re-implantation and 1 case of conversion to arthrodesis in the PCM group. There was 1 case of conversion to PVA in the CM group. Three patients who underwent PCM had a documented postoperative infection requiring antibiotics. Conclusion: Our data suggests that the addition of polyvinyl alcohol implant in the treatment of hallux rigidus results in significant improvement in patient-reported outcomes. However, patient-reported physical function may not be up to par at minimum 1-year follow-up compared to cheilectomy and Moberg osteotomy alone. In addition, while incidence was low in our cohort, revision of the implant as well as conversion to arthrodesis remain possible complications of PVA. Therefore, we believe that proper patient selection is recommended when considering surgical treatment options for hallux rigidus. [Table: see text]

scholarly journals Comparison of Patient Reported Outcomes (PROs) for Major Pathologies of the Forefoot, Midfoot, Hindfoot, and Achilles Using PROMIS

2020 ◽  
Vol 5 (4) ◽  
pp. 2473011420S0026
Author(s):  
Daniel A. Hu ◽  
Rusheel Nayak ◽  
Elijah O. Ogunkoya ◽  
Milap Patel ◽  
Anish R. Kadakia
Keyword(s):  
Physical Function ◽  
Clinical Outcomes ◽  
Patient Reported Outcomes ◽  
Postoperative Outcomes ◽  
Anatomical Location ◽  
Foot And Ankle ◽  
Patient Reported ◽  
Pain Outcomes ◽  
One Year ◽  
One Way Anova

Category: Other; Hindfoot; Midfoot/Forefoot Introduction/Purpose: Many legacy patient reported outcomes (PROs) lack sufficient validity and reliability for the evaluation of clinical outcomes following foot and ankle procedures. Patient-Reported Outcomes Measurement Information System (PROMIS) is a newly developed PRO that has been validated for the general foot and ankle surgical population. It has since been used to assess the clinical outcomes of a variety of specific foot and ankle procedures. However, there is little data regarding clinical outcomes of patients at a more intermediate subgroup level. There has been some preconceptions that the different anatomic aspects of foot and ankle surgery have disparate functional and pain improvement. Thus, our study utilizes PROMIS to assess postoperative outcomes based on anatomical location in patients undergoing forefoot, midfoot, hindfoot, and Achilles procedures. Methods: Preoperative and one year postoperative PROMIS Physical Function (PF) and Pain Interference (PI) were prospectively collected from a cohort of patients undergoing a foot and ankle procedure at a tertiary medical center. The cohort was split into forefoot, midfoot, hindfoot, and Achilles procedure groups with 355, 95, 356, and 135 patients, respectively. Paired-t tests were used to compare preoperative versus postoperative outcomes within operative groups, while a one-way ANOVA was used to detect differences in PROMIS scores between operative groups. Results: Paired t-tests indicated that all four operative groups had significantly improved PROMIS PF and PI scores preoperatively versus one year postoperatively (all P <.001)(see attached figure). One-way ANOVA demonstrated that there were no differences in postoperative PROMIS PF and PI scores between the groups. A majority of patients achieved the minimal clinically important difference (MCID) level of improvement in PROMIS PF and PI scores following surgery. Conclusion: All four operative groups (forefoot, midfoot, hindfoot, Achilles) had significantly improved PROMIS PF and PI scores postoperatively compared to preperatively, indicating an improvement in physical function and pain outcomes in each of the operative groups. However, there were no differences in physical function and pain outcomes between the groups. [Table: see text]

One-year Follow-Up Results with Hydrogel Implant in Therapy of Hallux Rigidus: Case Series with 44 Patients

2021 ◽  
Author(s):  
Christoph Zanzinger ◽  
Norbert Harrasser ◽  
Oliver Gottschalk ◽  
Patrick Dolp ◽  
Florian Hinterwimmer ◽  
...  
Keyword(s):  
Learning Algorithm ◽  
Case Series ◽  
Metatarsophalangeal Joint ◽  
Hallux Rigidus ◽  
Therapy Failure ◽  
Retrospective Case ◽  
Aofas Score ◽  
Medium Level ◽  
One Year

Abstract Background The Cartiva implant (CI) is being increasingly used in the surgical therapy of hallux rigidus. Despite a growing number of studies, numerous questions regarding patient selection remain unanswered. Patients and Methods As part of a retrospective case series with prospective follow-up (average follow-up period: 12 months), a total of 44 patients (male/female = 16/28; mean age at the time of surgery: 55.4 years) with 44 CI were analysed (VAS, EFAS-, AOFAS-score). Using a correlation analysis and a machine learning algorithm, risk factors for therapy failure were investigated. Results The overall survival rate of the CI was 93% at 12 months. The VAS, EFAS and AOFAS scores showed a significant improvement in comparison to the preoperative condition. The mobility of the metatarsophalangeal joint showed no increase. Patients with a medium osteoarthritis grade and a medium level of clinical restraint showed the greatest improvement in relation to their preoperative condition. Conclusion The CI can be seen as an effective therapy for hallux rigidus. Nonetheless, realistic patient expectations must be communicated.

scholarly journals Increased Early Revision Rate with the INFINITY Total Ankle Prosthesis

2018 ◽  
Vol 3 (3) ◽  
pp. 2473011418S0003
Author(s):  
Elizabeth Cody ◽  
Michel Taylor ◽  
James Nunley ◽  
Selene Parekh ◽  
James DeOrio
Keyword(s):  
United States ◽  
Tibial Component ◽  
Revision Rate ◽  
The United States ◽  
Additional Patient ◽  
Foot And Ankle ◽  
Early Revision ◽  
One Year ◽  
Component Loosening

Category: Ankle Arthritis Introduction/Purpose: Modern total ankle arthroplasties (TAAs) have demonstrated improved survival rates at early- and mid-term follow-up, with revision rates ranging from 4 to 8% at five years. The INFINITY total ankle system (Wright Medical Technology, Arlington, TN) was first used in the United States in 2014. Its advantages include the ability to use patient-specific instrumentation and the option to choose between talar dome resurfacing and flat-cut talar components. While this implant is currently popular in the United States, clinical outcomes have not yet been reported. Our aim was to identify the rate of early revision among patients receiving the INFINITY prosthesis. Methods: Patients from two prospectively-collected databases at the authors’ institution were screened for inclusion in the present study. All patients who underwent a primary TAA with the INFINITY prosthesis and who were at least one year postoperative were included. All surgeries were performed by one of two orthopaedic foot and ankle surgeons with extensive experience in total ankle arthroplasty. The primary outcome was the need for revision surgery, which was defined as removal of one or both metal components. Peri-implant lucency at most recent follow-up was a secondary outcome. Anteroposterior and lateral radiographs at most recent follow-up were graded for lucency independently by two reviewers, both orthopaedic foot and ankle fellows, for individual peri-implant zones (Figure). Each zone was only considered “lucent” if recorded as such by both reviewers. Results: 160 patients underwent TAA with the INFINITY prosthesis between August 2014 and November 2016 with a mean 20 months of follow-up (range, 12-37). Six patients were lost to follow-up. Sixteen patients (10%) underwent revision a mean 1.2 years postoperatively. Revision was performed most commonly for tibial component loosening (seven patients, 4.4%) and deep infection (five patients, 3.1%). Of cases with tibial loosening, progressive lucency and/or subsidence was obvious radiographically in four patients; one patient had equivocal radiographs but loosening was suggested on single-photon emission computed tomography; and two patients revised for persistent pain had loosening confirmed intraoperatively. Of the 108 patients with retained components and at least one year of radiographic follow-up, eight (7.4%) had global lucency around the tibial component at most recent follow-up. Conclusion: Our initial review of patients undergoing TAA with the INFINITY prosthesis demonstrates an elevated early revision rate due to tibial component loosening. The reasons for this finding remain unclear, but could possibly include inadequate bony purchase of the implant’s three prongs, particularly in patients with large preoperative deformities or with imperfect component alignment. We plan to further investigate the possible reasons for this finding in the future by assessing additional patient factors, including age, sex, arthritis type, tobacco use, pre- and postoperative coronal and sagittal alignment, and presence of ipsilateral hindfoot fusion.

Subspinal impingement: clinical outcomes of arthroscopic decompression with one year minimum follow up

2018 ◽  
Vol 28 (9) ◽  
pp. 2756-2762 ◽  
Author(s):  
Frankl Michal ◽  
Eyal Amar ◽  
Ran Atzmon ◽  
Zachary Sharfman ◽  
Barak Haviv ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
One Year

First Metatarsophalangeal Arthrodesis After Failed Distal Chevron Osteotomy for Hallux Valgus

2020 ◽  
pp. 107110072096883
Author(s):  
Maria Tiscar Garcia-Ortiz ◽  
Jose Juan Talavera-Gosalbez ◽  
Lorena Moril-Peñalver ◽  
Maria Dolores Fernandez-Ruiz ◽  
Carolina Alonso-Montero ◽  
...  
Keyword(s):  
Cohort Study ◽  
Clinical Outcomes ◽  
Hallux Valgus ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
Hallux Rigidus ◽  
Primary Group ◽  
Plate Removal ◽  
The Mean

Background: The purpose of this study was to compare the clinical outcomes after first metatarsophalangeal (MTP) joint arthrodesis for hallux rigidus between patients who underwent primary arthrodesis and those who had had a prior surgery for hallux valgus. Methods: Our design was a retrospective cohort study comparing 29 patients who underwent primary arthrodesis (primary group) and 34 patients with hallux rigidus after hallux valgus surgery (secondary group). The clinical assessment included the American Orthopaedic Foot & Ankle Society (AOFAS) score and a visual analog scale (VAS) for pain. Radiological evaluation was also performed. Overall, the mean postoperative follow-up was 3.4 (range, 2-5) years. Results: At final follow-up, AOFAS and VAS pain scores significantly improved in both groups ( P = .001). However, the mean AOFAS ( P = .001) and VAS pain ( P = .008) scores were significantly better in the primary group than in the secondary group. Radiologically, there were no significant differences between the groups in any angle after arthrodesis. Revision surgeries were not required in the primary group. In the secondary group, there was 1 revision due to deep infection, and 3 other patients required dorsal plate removal. Excluding plate removal, the Kaplan-Meier survival at 3 years was not significantly different between groups ( P = .775). Conclusion: Although arthrodesis of the first MTP joint was an effective procedure for hallux rigidus, the clinical outcomes in patients who had prior hallux valgus surgery were worse than those for patients who underwent primary surgery for hallux rigidus. Level of Evidence: Level III, retrospective cohort study.

scholarly journals What is the Responsiveness and Quality of Life “Utility” for PROMIS Outcomes in Foot and Ankle Patients Following Physical Therapy?

2020 ◽  
Vol 5 (4) ◽  
pp. 2473011420S0036
Author(s):  
Christopher G. Neville ◽  
Judith F. Baumhauer ◽  
Jeff Houck
Keyword(s):  
Quality Of Life ◽  
Physical Therapy ◽  
Physical Function ◽  
Health State ◽  
Foot And Ankle ◽  
T Score ◽  
The Impact ◽  
Utility Scores

Category: Other Introduction/Purpose: Patients with foot and ankle conditions have been shown to demonstrate improvement in their generic outcomes using the Patient Reported Outcome Measurement Information System (PROMIS). However, the responsiveness to change and the impact change may have on quality of life has not been explored following non-operative care with physical therapy. The effect size (ES) is an assessment of the magnitude of change while the impact of change in physical function can be assed with quality of life utility scores. Therefore, the purpose of this analysis was to investigate the responsiveness of the PROMIS physical function (PF) scale on changes in quality of life. Methods: The PROMIS PF scale was available at the start and end of physical therapy treatment for 352 patients with foot and ankle ICD10 codes. PF was chosen as a good outcome measure to assess overall outcome from physical therapy care. Changes from baseline to post-care were examine using Cohen’s d to remove dependence on sample size and was interpreted as d=0.20 as a small effect, d=0.05 as a medium effect, and d=0.80 as a large effect. Using available isotonic regression with linear interpolation functions, health state utility scores were calculated from the PROMIS PF scores. These scores represent a health state between 0, representing ‘being dead’, and 1 being the utility of ‘full health’. This methodology has been shown to be reliable and valid for assessing overall health quality of life from changes in physical function. Repeated measures ANOVA models were used to compare outcomes across time. Results: A significant improvement (p<0.01) in PF scores was seen across the sample following physical therapy (PF t-score; baseline 38.6+-8.8; follow-up 45+-9.1). This change was associated with a moderate to large ES of 0.75. The average ES for those subjects with a starting t-score less than 45 (n=294) was 0.86 (large effect) while for those with a starting t-score of greater than 45 (n=58) was 0.27 (small effect). There was also a significant (p<0.01) improvement in utility scores following physical therapy (utility score; baseline 0.58+-0.2; follow-up 0.72+-0.2). Conclusion: There is a general improvement in reported physical function following physical therapy but the magnitude of this effect depends on baseline function. Lower function is associated with greater changes. Improvement in physical function was associated with an overall improvement in quality of life. The non-linear nature of utility scores suggests some patients may have large increases in quality of life with small changes in physical function.

scholarly journals Reliability of Hallux Rigidus Radiographic Grading System

2015 ◽  
Vol 8 (4) ◽  
pp. 125-134
Author(s):  
Ryan C. Pate ◽  
John W. Fanning ◽  
Naomi N. Shields ◽  
Alexander C.M. Chong
Keyword(s):  
Weight Bearing ◽  
Hallux Rigidus ◽  
Observer Agreement ◽  
Grading System ◽  
Foot And Ankle ◽  
Substantial Agreement ◽  
Radiographic Images ◽  
Observer Reliability ◽  
Grade 3 ◽  
Radiographic Grading

Introduction. The purpose of this study was to determine the inter- and intra-observer reliability of a clinical radiographic scale for hallux rigidus. Methods. A total of 80 patients were retrospectively selected from the patient population of two foot and ankle orthopaedic surgeons. Each corresponding series of radiographic images (weight-bearing anteroposterior, weight-bearing lateral, and oblique of the foot) was randomized and evaluated. Re-randomization was performed and the corresponding radiograph images re-numbered. Four orthopaedic foot and ankle surgeons graded each patient, and each rater reclassified the re-randomized radiographic images three weeks later. Results. Sixty-one out of 80 patients (76%) were included in this study. For intra-observer reliability, most of the raters showed “excellent” agreement except one rater had a “substantial” agreement. For inter-observer reliability, only 14 out of 61 cases (23%) showed total agreement between the eight readings from the four surgeons, and 11 out of the 14 cases (79%) were grade 3 hallux rigidus. One of the raters had a tendency to grade at a higher grade resulting in poorer agreement. If this rater was excluded, the results demonstrated a “substantial” agreement by using this classification. Conclusion. The hallux rigidus radiographic grading system should be used with caution. Although there is an “excellent” level of intra-observer agreement, there is only “moderate” to “substantial” level of inter-observer reliability.

scholarly journals Timing of Supervised Physical Therapy after Hindfoot Fractures

2017 ◽  
Vol 2 (3) ◽  
pp. 2473011417S0000
Author(s):  
Stephanie Albin ◽  
Drew Van Boerum ◽  
James Morgan ◽  
Shane Koppenhaver
Keyword(s):  
Physical Therapy ◽  
Clinical Outcomes ◽  
Manual Therapy ◽  
Foot And Ankle ◽  
Therapeutic Exercise ◽  
Therapy Program ◽  
Surgical Fixation ◽  
Physical Therapy Program

Category: Ankle, Hindfoot Introduction/Purpose: Fractures to the hindfoot, including the talus and calcaneus, have devastating long-term functional outcomes. To date, no randomized trials have been done assessing the best time to initiate physical therapy after surgical fixation of these fractures. The purpose of this study is to assess whether initiating a supervised physical therapy program including therapeutic exercise and manual therapy two weeks post-operatively (EARLY) versus seven weeks post-operatively (LATE) in patients following surgical fixation for these fractures results in differences in clinical outcomes. The secondary purpose of this study is to assess what factors predict outcomes after these hindfoot fractures. Methods: Fifty patients between the ages of 18-70 years having undergone an open reduction internal fixation (ORIF) of the calcaneus or talus were recruited to participate from two foot and ankle fellowship-trained orthopedic surgeons. Subjects were randomly assigned to initiate formal physical therapy starting within 2 weeks post-operatively (EARLY) (n=26) or 8 weeks post-operatively (LATE) (n=24). Treatment for both groups consisted of impairment based manual therapy and therapeutic exercise. The lower extremity functional scale (LEFS), the American Orthopeadic Foot and Ankle Society (AOFAS) hindfoot scale, range of motion (ROM), pain and girth measurements to assess swelling were the outcome measures for this study. Subjects in both groups were seen for a total of 10 visits. All subjects underwent follow-up assessments at 3 months, 6 months, and 12 months post-operatively. Between-group differences were analyzed using ANCOVAs with baseline scores as covariates. Regression was used to assess factors predicting patients’ self-reported outcomes. Results: Results demonstrated no significant differences between the groups at any time point (3, 6 or 12 months) for the LEFS (p=0.637) or the AOFAS (p=0.634). No significant differences existed between the two groups for active ROM (p=0.106) or swelling (p=0.389). Subjects in both groups demonstrated improved AOFAS scores from baseline to one year follow-up by 26 points (p=0.00); however, most of the change occurred within the first 6 months post-operatively with only a 1.722 (95% CI -3.63 to 7.08) change between 6 to 12 month follow-up visits. Baseline anxiety (as measured by the Beck Anxiety Questionnaire) significantly predicted LEFS scores at both the 6 month and 12 month follow-up periods (r= -0.55, p=0.0015 and r= -0.53, p=0.007). Conclusion: This study did not demonstrate that initiating early supervised physical therapy (within 2 weeks after surgical fixation) improves self-reported outcomes for patients after surgical fixation of a hindfoot fracture as assessed by the LEFS, the AOFAS hindfoot scores, or clinical outcomes such as ROM or swelling compared to patients initiating a formal physical therapy program seven weeks after surgery. Although, many these patients typically have less than ideal clinical outcomes, it is possible that addressing other factors such as anxiety may help improve long-term outcomes.

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