Prospective study of disc repair with allogeneic chondrocytes Presented at the 2012 Joint Spine Section Meeting

2013 ◽  
Vol 18 (1) ◽  
pp. 85-95 ◽  
Author(s):  
Domagoj Coric ◽  
Kenneth Pettine ◽  
Andrew Sumich ◽  
Margaret O. Boltes
Keyword(s):  
Rating Scale ◽  
Short Form ◽  
Total Disc Replacement ◽  
Controlled Study ◽  
Lumbar Spondylosis ◽  
Cell Based Therapy ◽  
Sf 36 ◽  
Disc Repair ◽  
The Mean

Object The purpose of the study was to evaluate the safety and initial efficacy of NuQu allogeneic juvenile chondrocytes delivered percutaneously for the treatment of lumbar spondylosis with mechanical low-back pain (LBP). NuQu is a cell-based biological therapy for disc repair. The authors report the results at 12 months of the NuQu Phase I investigational new drug (IND) single-arm, prospective feasibility study for the treatment of LBP for single-level degenerative disc disease (Pfirrman Grades III–IV) at L3–S1. Methods Fifteen patients (6 women and 9 men) were enrolled at 2 sites. Institutional review board approval was obtained, and all patients signed a study-specific informed consent. All patients have completed a minimum of 1 year of follow-up. Patients were evaluated pretreatment and at 1, 3, 6, and 12 months posttreatment. Evaluations included routine neurological examinations, serum liver and renal function studies, MRI, the Oswestry Disability Index (ODI), the Numerical Rating Scale (NRS), and the 36-Item Short Form Health Survey (SF-36). Results Fifteen patients were treated with a single percutaneous delivery of NuQu juvenile chondrocytes. The mean patient age was 40 years (19–47 years). Each treatment consisted of 1–2 ml (mean injection 1.3 ml) of juvenile chondrocytes (approximately 107 chondrocyte cells/ml) with fibrin carrier. The mean peak pressure during treatment was 87.6 psi. The treatment time ranged from 5 to 33 seconds. The mean ODI (baseline 53.3, 12-month 20.3; p < 0.0001), NRS (baseline 5.7, 12-month 3.1; p = 0.0025), and SF-36 physical component summary (baseline 35.3, 12-month 46.9; p = 0.0002) scores all improved significantly from baseline. At the 6-month follow-up, 13 patients underwent MRI (one patient underwent CT imaging and another refused imaging). Ten (77%) of these 13 patients exhibited improvements on MRI. Three of these patients showed improvement in disc contour or height. High-intensity zones (HIZs), consistent with posterior anular tears, were present at baseline in 9 patients. Of these, the HIZ was either absent or improved in 8 patients (89%) by 6 months. The HIZ was improved in the ninth patient at 3 months, with no further MRI follow-up. Of the 10 patients who exhibited radiological improvement at 6 months, findings continued to improve or were sustained in 8 patients at the 12-month follow-up. No patient experienced neurological deterioration. There were no disc infections, and there were no serious or unexpected adverse events. Three patients (20%) underwent total disc replacement by the 12-month follow-up due to persistent, but not worse than baseline, LBP. Conclusions This is a 12-month report of the clinical and radiographic results from a US IND study of cell-based therapy (juvenile chondrocytes) in the treatment of lumbar spondylosis with mechanical LBP. The results of this prospective cohort are promising and warrant further investigation with a prospective, randomized, double-blinded, placebo-controlled study design. Clinical trial registration no.: BB-IND 13985.

scholarly journals Arthroscopic lift, drill, fill and fix (LDFF) is an effective treatment option for primary talar osteochondral defects

2019 ◽  
Vol 28 (1) ◽  
pp. 141-147 ◽  
Author(s):  
Kaj T. A. Lambers ◽  
Jari Dahmen ◽  
Mikel L. Reilingh ◽  
Christiaan J. A. van Bergen ◽  
Sjoerd A. S. Stufkens ◽  
...  
Keyword(s):  
Rating Scale ◽  
Short Form ◽  
Case Series ◽  
Ct Scans ◽  
Osteochondral Defects ◽  
Effective Treatment Option ◽  
Level Of Evidence ◽  
Sf 36 ◽  
The Mean

Abstract Purpose The purpose of this study was to describe the mid-term clinical and radiological results of a novel arthroscopic fixation technique for primary osteochondral defects (OCD) of the talus, named the lift, drill, fill and fix (LDFF) technique. Methods Twenty-seven ankles (25 patients) underwent an arthroscopic LDFF procedure for primary fixable talar OCDs. The mean follow-up was 27 months (SD 5). Pre- and post-operative clinical assessments were prospectively performed by measuring the Numeric Rating Scale (NRS) of pain in/at rest, walking and when running. Additionally, the Foot and Ankle Outcome Score (FAOS) and the Short Form-36 (SF-36) were used to assess clinical outcome. The patients were radiologically assessed by means of computed tomography (CT) scans pre-operatively and 1 year post-operatively. Results The mean NRS during running significantly improved from 7.8 pre-operatively to 2.9 post-operatively (p = 0.006), the NRS during walking from 5.7 to 2.0 (p < 0.001) and the NRS in rest from 2.3 to 1.2 (p = 0.015). The median FAOS at final follow-up was 86 for pain, 63 for other symptoms, 95 for activities of daily living, 70 for sport and 53 for quality of life. A pre- and post-operative score comparison was available for 16 patients, and improved significantly in most subscores. The SF-36 physical component scale significantly improved from 42.9 to 50.1. Of the CT scans at 1 year after surgery, 81% showed a flush subchondral bone plate and 92% of OCDs showed union. Conclusion Arthroscopic LDFF of a fixable primary talar OCD results in excellent improvement of clinical outcomes. The radiological follow-up confirms that fusion of the fragment is feasible in 92%. This technique could be regarded as the new gold standard for the orthopedic surgeon comfortable with arthroscopic procedures. Level of evidence Prospective case series, therapeutic level IV.

Arthroscopic Microfracture for Osteochondral Lesions of the Talus: Functional Outcomes at a Mean of 6.7 Years in 165 Consecutive Ankles

2019 ◽  
Vol 48 (1) ◽  
pp. 153-158 ◽  
Author(s):  
Seung-Won Choi ◽  
Gun-Woo Lee ◽  
Keun-Bae Lee
Keyword(s):  
Functional Outcomes ◽  
Short Form ◽  
Arthroscopic Surgery ◽  
Case Series ◽  
Osteochondral Lesions ◽  
Study Cohort ◽  
Arthroscopic Microfracture ◽  
Sf 36 ◽  
The Mean

Background: Arthroscopic microfracture for osteochondral lesions of the talus (OLT) has shown good functional outcomes. However, some studies have reported that functional outcomes deteriorate over time after surgery. Purpose: To use various functional scoring systems to evaluate functional outcomes in a large sample of patients with OLT treated by arthroscopic microfracture. Study Design: Case series; Level of evidence, 4. Methods: The study cohort consisted of 165 ankles (156 patients) that underwent arthroscopic microfracture for small to mid-sized OLT. The mean lesion size was 73 mm2 (range, 17-146 mm2), and the mean follow-up period was 6.7 years (range, 2.0-13.6 years). The Foot and Ankle Outcome Score (FAOS), American Orthopaedic Foot & Ankle Society (AOFAS) ankle-hindfoot scale, visual analog scale (VAS) for pain, and 36-Item Short Form Health Survey (SF-36) were used to compare the functional outcomes between the preoperative and final follow-up assessments. Results: The mean FAOS significantly improved in regard to all subscores ( P < .001). The AOFAS ankle-hindfoot scale showed an improvement from 71.0 points (range, 47.0-84.0) preoperatively to 89.5 points (range, 63.0-100) at the final follow-up ( P < .001). The VAS score showed an improvement from 6.2 points (range, 4.0-9.0) preoperatively to 1.7 points (range, 0-6.0) at the final follow-up ( P < .001). The mean SF-36 score improved from 62.4 points (range, 27.4-76.6) preoperatively to 76.2 points (range, 42.1-98.0) at the final follow-up ( P < .001). Among 165 ankles, 22 ankles (13.3%) underwent repeat arthroscopic surgery for evaluation of repaired cartilage status. Conclusion: Arthroscopic microfracture showed good functional outcomes and improved quality of life with maintenance of satisfactory outcomes at a mean follow-up of 6.7 years. Therefore, arthroscopic microfracture seems to be reliable as a first-line treatment for OLT at an intermediate-term follow-up.

Solid radiographic fusion with a nonconstrained device 5 years after cervical arthroplasty

2014 ◽  
Vol 21 (6) ◽  
pp. 951-955 ◽  
Author(s):  
Robert F. Heary ◽  
Ira M. Goldstein ◽  
Katarzyna M. Getto ◽  
Nitin Agarwal
Keyword(s):  
Short Form ◽  
Total Disc Replacement ◽  
Neck Disability Index ◽  
Dynamic Imaging ◽  
Cervical Disc ◽  
First Case ◽  
Sf 36 ◽  
Index Site ◽  
Functional Scores

Cervical disc arthroplasty (CDA) has been gaining popularity as a surgical alternative to anterior cervical discectomy and fusion. Spontaneous fusion following a CDA is uncommon. A few anecdotal reports of heterotrophic ossification around the implant sites have been noted for the BRYAN, ProDisc-C, Mobi-C, PRESTIGE, and PCM devices. All CDA fusions reported to date have been in devices that are semiconstrained. The authors reported the case of a 56-year-old man who presented with left C-7 radiculopathy and neck pain for 10 weeks after an assault injury. There was evidence of disc herniation at the C6–7 level. He was otherwise healthy with functional scores on the visual analog scale (VAS, 4.2); neck disability index (NDI, 16); and the 36-item short form health survey (SF-36; physical component summary [PSC] score 43 and mental component summary [MCS] score 47). The patient underwent total disc replacement in which the DISCOVER Artificial Cervical Disc (DePuy Spine, Inc.) was used. The patient was seen at regular follow-up visits up to 60 months. At his 60-month follow-up visit, he had complete radiographic fusion at the C6–7 level with bridging trabecular bone and no motion at the index site on dynamic imaging. He was pain free, with a VAS score of 0, NDI score of 0, and SF-36 PCS and MCS scores of 61 and 55, respectively. Conclusions This is the first case report that identifies the phenomenon of fusion around a nonconstrained cervical prosthesis. Despite this unwanted radiographic outcome, the patient's clinical outcome was excellent.

scholarly journals Temporary Bridge Plating vs Primary Arthrodesis of the First Tarsometatarsal Joint in Lisfranc Injuries: Randomized Controlled Trial

2020 ◽  
Vol 41 (8) ◽  
pp. 901-910
Author(s):  
Are H. Stødle ◽  
Kjetil H. Hvaal ◽  
Helga M. Brøgger ◽  
Jan Erik Madsen ◽  
Elisabeth Ellingsen Husebye
Keyword(s):  
Short Form ◽  
Secondary Outcome ◽  
Controlled Study ◽  
First Metatarsal ◽  
Randomized Controlled ◽  
Anatomic Reduction ◽  
Sf 36 ◽  
Lisfranc Injuries ◽  
Bridge Plating

Background: Unstable Lisfranc injuries are best treated with anatomic reduction and stable fixation. There are controversies regarding which type of stabilization is best. In the present study, we compared primary arthrodesis of the first tarsometatarsal (TMT) joint to temporary bridge plating in unstable Lisfranc injuries. Methods: Forty-eight patients with Lisfranc injuries were included and followed for 2 years. Twenty-four patients were randomized to primary arthrodesis (PA) of the medial 3 TMT joints, whereas 24 patients were randomized to temporary bridge plate (BP) over the first TMT joint and primary arthrodesis of the second and third TMT joints. The main outcome parameter was the American Orthopaedic Foot & Ankle Society (AOFAS) midfoot scale and the secondary outcome parameters were the 36-Item Short Form Health Survey (SF-36) and visual analog scale for pain (VAS pain). Computed tomography (CT) scans pre- and postoperatively were obtained. Radiographs were obtained at follow-ups. Pedobarographic examination was performed at the 2-year follow-up. Twenty-two of 24 patients in the PA and 23/24 in the BP group completed the 2-year follow-up. Results: The mean AOFAS midfoot score 2 years postoperatively was 89 (SD 9) in the PA group and 85 (SD 15) in the BP group ( P = .32). There were no significant differences between the groups with regard to SF-36 or VAS pain scores. The alignment of the first metatarsal was better in the BP group than in the PA group measured by the anteroposterior Meary angle ( P = .04). The PA group had a reduced peak pressure under the fifth metatarsal ( P = .047). In the BP group, 11/24 patients had radiologic signs of osteoarthritis in the first TMT joint. Conclusion: Both treatment groups had good outcome scores. The first metatarsal was better aligned in the BP group; however, there was a high incidence of radiographic osteoarthritis in this group. Level of Evidence: Therapeutic level I, prospective randomized controlled study.

Thumb carpometacarpal osteoarthritis: trapeziectomy versus pyrocarbon interposition implant (Pi2) arthroplasty

2012 ◽  
Vol 37 (7) ◽  
pp. 617-620 ◽  
Author(s):  
M. Maru ◽  
P. Jettoo ◽  
L. Tourret ◽  
M. Jones ◽  
L. Irwin
Keyword(s):  
Short Form ◽  
Point Scale ◽  
High Complication Rate ◽  
Short Term ◽  
Early Results ◽  
Sf 36 ◽  
The Mean ◽  
Thumb Carpometacarpal ◽  
Carpometacarpal Osteoarthritis

We retrospectively compared the short-term outcomes of 18 thumbs that had a trapeziectomy and 18 that had a pyrocarbon interposition implant (Pi2) arthroplasty in 33 patients. We measured the Disability of the Arm, Shoulder, and Hand (DASH) and Short Form 36 (SF-36) scores at a mean of 20 months. Pain severity was assessed using a visual analogue scale (VAS), and level of patient satisfaction was assessed using a 5-point scale. The mean DASH scores at follow up were 27 for those that had a trapeziectomy and 35 for those that had a Pi2 arthroplasty ( p = 0.001). There was no difference in the VAS for pain, SF-36 scores, or other parameters assessed. Six out of 18 (33%) thumbs in the Pi2 group had multiple operations, usually for dislocation or subluxation of the implant. The early results of Pi2 arthroplasty show a high complication rate compared with trapeziectomy and no identifiable benefit.

Outcomes of Evans Versus Hintermann Calcaneal Lengthening Osteotomy for Flexible Flatfoot

2019 ◽  
Vol 40 (6) ◽  
pp. 661-671 ◽  
Author(s):  
Sarah Ettinger ◽  
Tim Mattinger ◽  
Christina Stukenborg-Colsman ◽  
Daiwei Yao ◽  
Leif Claassen ◽  
...  
Keyword(s):  
Rating Scale ◽  
Short Form ◽  
Surgical Techniques ◽  
Degenerative Changes ◽  
Ucla Activity Score ◽  
Metatarsal Angle ◽  
Sf 36 ◽  
Flexible Flatfoot ◽  
Significant Correction

Background: Evans (E) and Hintermann (H) lateral lengthening calcaneal osteotomies (LLCOTs) are commonly used to correct flexible flatfoot deformities. Both methods are well accepted and produce good clinical results. The aim of this study was to compare the postoperative outcomes of both osteotomies. Methods: We retrospectively examined 53 patients with flatfoot deformities, who received surgery between October 2008 and March 2014. Seventeen E-LLCOT and 36 H-LLCOT procedures were performed during this time period, with a mean follow-up of 67.7 ± 20.6 and 40 ± 12.9 months, respectively. Data were collected using clinical and radiological examination, as well as clinical scores (Foot and Ankle Outcome Score [FAOS], University of California at Los Angeles [UCLA] activity score, numerical rating scale [NRS], and the Short-Form 36-item Health Survey [SF-36]) during regular follow-up. Results: For both groups of patients, the FAOS score, pain-NRS, and SF-36 improved significantly following surgery ( P < .05). The talus–second metatarsal angle, talonavicular coverage, and naviculocuneiform overlap showed significant correction ( P < .05). Postoperatively, radiographic degenerative changes were detected in the calcaneocuboid (CC) and subtalar joint in both groups of patients: 41% and 18% after E-LLCOT compared with 25% and 14% after H-LLCOT, although these changes did not have any clinical relevance ( P < .05). No secondary arthrodesis was necessary. There were no significant differences in the clinical or radiological outcome parameters when compared between the 2 groups. Conclusion: Both surgical techniques resulted in a significant improvement of clinical outcome scores and led to good radiological correction of flatfoot deformities. It appears that the CC joint develops less degenerative changes following the H-LLCOT procedure. Level of Evidence: Level III, comparative series.

Chopart amputation with tibiotalocalcaneal arthrodesis and free flap reconstruction for severe foot crush injury

2018 ◽  
Vol 100-B (10) ◽  
pp. 1359-1363 ◽  
Author(s):  
Y-C. Chiu ◽  
T-C. Chung ◽  
C-H. Wu ◽  
K-L. Tsai ◽  
I-M Jou ◽  
...  
Keyword(s):  
Short Form ◽  
Treatment Method ◽  
Crush Injury ◽  
Soft Tissue Coverage ◽  
Walking Ability ◽  
Sf 36 ◽  
Crush Injuries ◽  
The Mean ◽  
One Year

AimsThis study reports the outcomes of a technique of soft-tissue coverage and Chopart amputation for severe crush injuries of the forefoot.Patients and MethodsBetween January 2012 to December 2016, 12 patients (nine male; three female, mean age 38.58 years; 26 to 55) with severe foot crush injury underwent treatment in our institute. All patients were followed-up for at least one year. Their medical records, imaging, visual analogue scale score, walking ability, complications, and functional outcomes one year postoperatively based on the American Orthopedic Foot and Ankle Society (AOFAS) and 36-Item Short-Form Health Survey (SF-36) scores were reviewed.ResultsThe mean length of follow-up was 18.6 months (13 to 28). Two patients had a local infection, flap necrosis was seen in one patient, and one patient experienced a skin graft wound healing delay. Of the 12 patients, one had persistent infection and eventually required below-knee amputation, but pain-free walking was achieved in all the other patients. The mean one-year postoperative AOFAS and SF-36 scores were 75.6 (68 to 80) and 82 (74 to 88), respectively.ConclusionAlthough our sample size was small, we believe that this treatment method may be a valuable alternative for treating severe foot crush injuries. Cite this article: Bone Joint J 2018;100-B:1359–63.

scholarly journals Restless legs syndrome and quality of life in pregnant women

2019 ◽  
Vol 65 (5) ◽  
pp. 618-624
Author(s):  
Pınar Akbaş ◽  
Şengül Yaman Sözbir
Keyword(s):  
Quality Of Life ◽  
Pregnant Women ◽  
Restless Legs Syndrome ◽  
Rating Scale ◽  
Short Form ◽  
Restless Legs ◽  
Sf 36 ◽  
Study Results ◽  
The Mean

SUMMARY OBJECTIVE: In this study, we aimed to determine the extent of restless legs syndrome (RLS) in pregnant women and evaluate the relationship between the syndrome and quality of life. METHODS: This is a cross-sectional descriptive study. A questionnaire developed by the researcher, the Short Form 36 (SF-36) Questionnaire to measure the quality of life, the International Restless Legs Syndrome Study Group (IRLSSG) Diagnostic Criteria for RLS and the Restless Legs Syndrome Rating Scale were applied to the women to collect the data. A total of 250 pregnant women were included in the study. RESULTS: The mean age of the women was 28.11 ± 5.59 years and the mean gestational time was 26.26 ± 10.72 weeks. Symptoms of RLS were seen in 46.4 % of the women. The mean for the RLS Violence Rating Score was 20.82 ± 6.61 for the women with RLS. RLS was found to be mild in 5.2 % of the women, moderate in 45.7 %, severe in 40.5 % and very severe in 8.6 %. A statistically significant effect of RLS survival on quality of life was observed. CONCLUSION: These results indicate that almost half of the pregnant women in this study experienced RLS, and about half of those with RLS experienced severe or very severe RLS. There is a significant relationship between RLS and six domains of SF-36 (physical, role limitations, pain, general health perception, energy/vitality, and mental health).

scholarly journals A Modified Posterolateral Approach for the Treatment of Posterior Malleolar Fracture

2020 ◽  
Author(s):  
Fang Wenlai ◽  
Kong jianzhong ◽  
Chen mochuan
Keyword(s):  
Short Form ◽  
Operation Time ◽  
Healing Time ◽  
Posterolateral Approach ◽  
Flexor Hallucis Longus ◽  
Malleolar Fracture ◽  
Posterior Malleolar Fracture ◽  
Sf 36 ◽  
The Mean

Abstract Background: To observe the clinical effect of a modified posterolateral approach internal fixation in the treatment of posterior malleolar fracture. Method: From January 2015 to October 2018, 30 cases involving lateral and posterior malleolar fracture patient data were treated in our department. we observed operation time, fracture healing time and postoperative complications. At the time of the last follow-up, we evaluated ankle joint function by the American Orthopedic Foot Ankle Society (AOFAS) ankle- hindfoot scale, the Short Form-36 (SF-36) outcome Tools and the American Academy of Orthopaedic Surgeons (AAOS) Foot and Ankle Questionnaire. Result: In this group of 30 patients, the operation time of the patients was 80-120min (median 90min). The 25 patients were followed up for more than 1 year. 3 ~ 5 months after the operation, all the patients had bony healing. 3 cases with superficial wound infection. No other complication was found. The mean AOFAS scores at the postoperative 6-month, 12-month, and final follow-up were 78.4 (range, 72–90), 89.4 (range, 80–96), and 90.8 (range, 84–96), respectively. The mean SF-36 scores at the postoperative 12-month and final follow-up were 82.4 (range, 77.6–90.6) and 84.6 (range, 77.8–92.6), the mean AAOS scores at the postoperative 12-month and final follow-up were87.8 (range, 79–95), 90.6 (range, 82–96). Conclusion: Modified posterolateral approach avoided stripping the muscular origins of flexor hallucis longus, reduced the adhesion, and can fix the lateral and posterior malleolar fracture in the same incision, is worth popularizing in clinical.

Treatment of neurogenic claudication by interspinous decompression: application of the X STOP device in patients with lumbar degenerative spondylolisthesis

2006 ◽  
Vol 4 (6) ◽  
pp. 463-471 ◽  
Author(s):  
Paul A. Anderson ◽  
Cliff B. Tribus ◽  
Scott H. Kitchel
Keyword(s):  
Clinical Success ◽  
Short Form ◽  
Degenerative Spondylolisthesis ◽  
Nonoperative Treatment ◽  
Controlled Study ◽  
Neurogenic Claudication ◽  
Neurogenic Intermittent Claudication ◽  
Sf 36 ◽  
Degenerative Lumbar Spondylolisthesis

Object Interspinous process decompression (IPD) theoretically relieves narrowing of the spinal canal and neural foramen in extension and thus reduces the symptoms of neurogenic intermittent claudication (NIC). The purpose of this study was to compare the efficacy of IPD with nonoperative treatment in patients with NIC secondary to degenerative spondylolisthesis. Methods The authors conducted a randomized controlled study in patients with NIC; they compared the results obtained in patients treated with the X STOP IPD device with those acquired in patients treated nonoperatively. The X STOP implant is a titanium alloy device that is placed between the spinous processes to reduce the canal and foraminal narrowing that occurs in extension. In a cohort of 75 patients with degenerative spondylolisthesis, 42 underwent surgical treatment in which the X STOP IPD device was placed and 33 control individuals were treated nonoperatively. Patients underwent serial follow-up evaluations. The Zurich Claudication Questionnaire (ZCQ), 36-Item Short Form Health Survey (SF-36), and radiographic assessment were used to determine outcomes. Two-year follow-up data were obtained in 70 of 75 patients. Statistically significant improvement in ZCQ and SF-36 scores was seen in X STOP device–treated patients but not in the nonoperative control patients at all postoperative intervals. Overall clinical success occurred in 63.4% of X STOP device–treated patients and only 12.9% of controls. Spondylolisthesis and kyphosis were unaltered. Conclusions The X STOP device was more effective than nonoperative treatment in the management of NIC secondary to degenerative lumbar spondylolisthesis.

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