Clinical Evaluation of Safety and Efficacy of a Central Current Good Manufacturing Practices Laboratory Produced Autologous Adipose-Derived Stromal Vascular Fraction Cell Therapy Product for the Treatment of Knee Osteoarthritis.

Knee osteoarthritis (KOA) is a prevalent condition characterized by the progressive deterioration of the entire joint and has emerged as a prominent contributor to disability on a global scale. The nature of the disease and its impact on joint function significantly limit mobility and daily activities, highlighting its substantial influence on patients' overall well-being. Stromal vascular fraction (SVF) is a heterogenous, autologous cell product, containing mesenchymal stem cells, derived from the patient's subcutaneous adipose tissue with demonstrated safety and efficacy in the treatment of KOA patients. We conducted a single-arm, open-label, multisite, FDA approved clinical study in Kellgren-Lawrence severity grade 2-4 KOA patients. The cellular product was manufactured from patient-specific lipoaspirate in a centrally located FDA-compliant manufacturing facility. Twenty-nine subjects were treated with a quality tested single intra-articular injection of GMP manufactured SVF. Adverse events, laboratory values, vital signs, and physical examination findings were monitored during the study period. Robust tolerability, without any substantial safety issues, was demonstrated. Knee pain and function, assessed through the Knee Injury and Osteoarthritis Outcome Score (KOOS), demonstrated notable improvements. These positive benefits persisted for up to 12 months, and the majority of participants expressed satisfaction. SVF from each patient was stored in a liquid nitrogen freezer for future clinical treatments. Unique to this study of autologous cells is the shipment of lipoaspirate from the clinic to a central FDA-compliant manufacturing facility for cleanroom-controlled manufacturing. The cell product characterization data demonstrate that this method produces an equivalent product in terms of cell count and viability with the added benefit of further quality assurance testing, including sterility, endotoxin, and flow cytometry, before patient administration. Clinical Trial Registration Number: NCT04043819.

Conventional versus computer-assisted technique for total knee arthroplasty: a minimum of 5-year follow-up of 200 patients in a prospective randomized comparative trial.

In the literature, studies of computer-assisted total knee arthroplasty (TKA) after mid-term period are not conclusive and long-term data are rare. In a prospective, randomized, comparative study 100 conventional TKAs (group REG) were compared with 100 computer-assisted TKAs (group NAV). Minimum follow-up was 5years. No difference in implant failure was found with 1.1% in group NAV versus 4.6% in group REG (P=0.368). Group NAV showed a significantly less mean deviation of mechanical limb axis (P=0.015), more TKAs (90% versus 81% in group REG) were within 3° varus/valgus and a higher tibial slope and lateral distal femoral angle (LDFA) accuracy was found (P≤0.034). Clinical investigational parameters showed no differences (P≥0.058). Insall and HSS score total were also higher in group NAV (P≤0.016).

Early clinical results of a high-flexion, posterior-stabilized, mobile-bearing total knee arthroplasty: a US investigational device exemption trial.

Between May 2001 and June 2004, 388 total knee arthroplasty cases were enrolled in a prospective, randomized, multicenter investigational device exemption trial. Patients received either the investigational high-flexion mobile-bearing knee or a fixed-bearing control. At 2 to 4 years of follow-up, results in 293 patients with degenerative joint disease were compared using Knee Society Assessment and Function scores, radiographic results, complications analysis, and survival estimates. The mobile-bearing and fixed-bearing groups demonstrated similar, significant improvement over preoperative assessments in Knee Scores, maximum flexion, and range of motion. One mobile-bearing arthroplasty required revision. Radiographic results were unremarkable, and implant-related complications were rare in both groups. At this early follow-up, the investigational high-flexion mobile-bearing knee and its fixed-bearing counterpart demonstrated comparable, effective performance.

Comparison of two minimally invasive implantation instrument-sets for total knee arthroplasty.

Several choices of instrument systems are available for minimally invasive surgical approaches. There are reports that one alternative, the quadriceps sparing, side-cutting instrumentation, results in diminished implantation accuracy. A total of 108 patients were randomized to undergo TKA either using side-cutting implant instrumentation (Group A) or anterior-posterior mini-incision instrumentation (Group B). All TKAs were operated on with a minimal invasive, mini-midvastus surgical approach. 50% of the TKAs were performed with computer-assistance in each cohort. The radiographic parameters, clinical outcomes and knee scores were evaluated preoperatively and 3 months postoperative. In Group B, we found significantly higher accuracy for the mechanical axis of the limb (range +/-3 degrees: Group A 54% versus Group B 89%, p = <0.001), medial proximal tibial angle (range +/-3 degrees: Group A 85% versus Group B 98%, p = <0.027) and tibial slope (range +/-3 degrees: Group A 59% versus Group B 85%, p = <0.007). The application of the navigation system could only significantly reduce outliers (accuracy >3 degrees) in Group B. Clinical outcomes and knee scores were similar in both groups and were not influenced by computer-assistance. Using the anterior-posterior, mini-incision instruments for minimally invasive TKA will lead to higher implantation accuracy when compared to the quadriceps sparing side-cutting instrumentation. The navigation technique could not compensate for shortcomings of the side-cutting instrumentation. The clinical relevance of this study is that the quadriceps sparing side-cutting instrumentation should not be used for TKA because of unacceptable reduced implantation accuracy.

Accuracy of side-cutting implantation instruments for total knee arthroplasty.

A new generation of implantation instruments were developed for quadriceps sparing surgical approaches during total knee arthroplasty (TKA). There is little information on the accuracy of the bone cuts performed with the side-cutting technique. A total of 100 patients were randomized to undergo computer-assisted TKA or non-navigated TKA using a mini-subvastus surgical approach and side-cutting implant instrumentation. The radiographic parameters, clinical outcomes and knee scores were evaluated 3 months postoperative. The mechanical axis of the limb was within 3 degrees varus/valgus in 76% of the patients who had navigated procedures versus 66% of patients who had conventional surgery. The tibial slope showed a rate of inaccuracy of 3 degrees or less for 78% of the patients in the navigated total knee arthroplasty group versus 66% of the patients in the conventional group. Clinical outcomes and knee scores were similar in both groups. The navigation technique could not compensate for shortcomings of the implantation instruments.

Femoral fracture through a previous pin site after computer-assisted total knee arthroplasty.

Computer-assisted total knee arthroplasty has been gaining popularity given the proposed benefits of increased accuracy of the femoral and tibial cuts, quantitative feedback on soft tissue balancing, and the potential for performing the procedure through smaller incisions with decreased soft tissue trauma. Most navigation systems require femoral and tibial threaded pin insertion for placement of guidance trackers, which when removed leave behind defects in the bone that may act as stress risers. We present 2 cases of a femoral fracture through a previous pin site where a guidance tracker had been placed for computer-assisted total knee arthroplasty. Both patients were informed that data concerning the cases would be submitted for publication. To our knowledge, this complication has not previously been reported for this procedure.

Results of unicompartmental knee arthroplasty at a minimum of ten years of follow-up.

BACKGROUND: There is a renewed interest in unicompartmental knee arthroplasty. The present report describes the minimum ten-year results associated with a unicompartmental knee arthroplasty design that is in current use. METHODS: Sixty-two consecutive unicompartmental knee arthroplasties that were performed with cemented modular Miller-Galante implants in fifty-one patients were studied prospectively both clinically and radiographically. All patients had isolated unicompartmental disease without patellofemoral symptoms. No patient was lost to follow-up. Thirteen patients (thirteen knees) died after less than ten years of follow-up, leaving thirty-eight patients (forty-nine knees) with a minimum of ten years of follow-up. The average duration of follow-up was twelve years. RESULTS: The mean Hospital for Special Surgery knee score improved from 55 points preoperatively to 92 points at the time of the final follow-up. Thirty-nine knees (80%) had an excellent result, six (12%) had a good result, and four (8%) had a fair result. At the time of the final follow-up, thirty-nine knees (80%) had flexion to at least 120 degrees . Two patients (two knees) with well-fixed components underwent revision to total knee arthroplasty, at seven and eleven years, because of progression of patellofemoral arthritis. At the time of the final follow-up, no component was loose radiographically and there was no evidence of periprosthetic osteolysis. Radiographic evidence of progressive loss of joint space was observed in the opposite compartment of nine knees (18%) and in the patellofemoral space of seven knees (14%). Kaplan-Meier analysis revealed a survival rate of 98.0% +/- 2.0% at ten years and of 95.7% +/- 4.3% at thirteen years, with revision or radiographic loosening as the end point. The survival rate was 100% at thirteen years with aseptic loosening as the end point. CONCLUSIONS: After a minimum duration of follow-up of ten years, this cemented modular unicompartmental knee design was associated with excellent clinical and radiographic results. Although the ten-year survival rate was excellent, radiographic signs of progression of osteoarthritis in the other compartments continued at a slow rate. With appropriate indications and technique, this unicompartmental knee design can yield excellent results into the beginning of the second decade of use.

The progression of patellofemoral arthrosis after medial unicompartmental replacement: results at 11 to 15 years.

This study reports the 11-year to 15-year results of unicompartmental knee arthroplasty with an emphasis on failure mechanisms and progression of patellofemoral arthrosis. In a prospective study of 513 consecutive potential knee replacement candidates, 59 patients (12%) had medial unicompartmental arthroplasty of the knee. All 59 patients had isolated unicompartmental disease without clinical symptoms or radiographic evidence of patellofemoral arthritis. No patient was lost to followup. The average followup was 13 years (range, 11-15 years). The mean preoperative Hospital for Special Surgery knee score of 55 points (range, 30-79 points) improved to a mean of 90 points (range, 60-100 points) at final followup. Patellofemoral symptoms were present in 1.6% of patients at 10 years; this increased markedly to 10% of patients at 15 years (p < 0.01). Four patients (10%) had moderate or severe patellofemoral symptoms at final followup; two were revised to a primary total knee replacement at 7 and 11 years for progressive patellofemoral degeneration. No component was radiographically loose and no osteolysis was seen. The Kaplan-Meier survival with loosening or revision for any reason was 98.0% +/- 2.0% at 10 years and 95.7% +/- 4.3% at 15 years. At up to 15 years, unicompartmental knee arthroplasty yielded good clinical results; however, progressive patellofemoral arthritis was the primary mode of failure.

Extended trochanteric osteotomy in complex primary total hip arthroplasty. A brief note.

BACKGROUND: The extended trochanteric osteotomy has been a useful approach for patients undergoing revision total hip arthroplasty; however, it has not been well described as an approach for those undergoing complex primary total hip arthroplasty. The purpose of the present report is to describe our experience with the use of an extended trochanteric osteotomy for patients undergoing complex primary total hip arthroplasty. METHODS: Six patients underwent primary total hip arthroplasty with use of an extended trochanteric osteotomy. The reasons for the use of this technique included severe femoral deformity, removal of intraosseous hardware, and high-riding developmental hip dysplasia. A fully porous-coated femoral component with diaphyseal fixation was used for all reconstructions. The mean age of the patients at the time of surgery was fifty-six years. Clinical and radiographic evaluation was performed at a minimum of two years. RESULTS: After a mean duration of follow-up of fifty months, all patients had an osseointegrated, stable femoral component. The site of the extended trochanteric osteotomy healed in five of the six patients. One patient had nonunion at the osteotomy site and a fracture at the base of the greater trochanter, with a subsequent fracture of the femoral component. The mean Merle D'Aubigné and Postel pain and walking scores improved from 2.2 and 2.3 preoperatively to 5.3 and 4.7 at the time of the final follow-up (p < 0.001). CONCLUSIONS: The extended trochanteric osteotomy is useful for the correction of femoral deformity and facilitates the removal of intraosseous hardware in carefully selected patients undergoing complex primary total hip arthroplasty.

Affective and sensory dimensions of back pain.

Pain words used to communicate suffering were analyzed to identify specific dimensions of back pain. The words were obtained from a group of 131 patients suffering from back pain who described their discomfort on a standardized 87-item pain questionnaire. The results indicate that words descriptive of back pain are not associated in completely random ways. When patients complain of back pain, their report falls into 7 distinguishable patterns. The major pattern accounts for 38% of the variance and refers almost entirely to emotional discomfort. The second pattern accounts for 9% of the variance and is a mixed emotional and sensory factor. The remaining 5 patterns account for 29% of the variance and constitute an entirely sensory class of factors.