There is growing evidence in literature that meniscal allograft transplantation performed with the right indications results in significant pain relief and functional improvement of the involved joint. Long-term data on clinical and radiological outcome are however scarce. We evaluated 89 transplants (53 lateral and 36 medial) in 87 patients. Mean time of follow-up was 15,5 ± 2,85 years (range 9,9–20,4), mean age at surgery was 35,2 years (range 22–50). Clinically, the patients were evaluated using a KOOS, SF-36, HSS, VAS, Tegner and Lysholm score. HSS scores were compared to pre-operative and mid-term follow-up data. Each patient received radiographs (AP, profile and Rosenberg view). Radiological outcome parameters were joint space width narrowing and Fairbank changes and were scored according to IKDC. Failures were defined as patients who were converted to an arthroplasty.Background
Methods
Osteoarthritis (OA) represents a leading cause of disability and a growing burden on healthcare budgets. OA is particularly vexing for young, active patients who have failed less invasive therapies but are not ideal candidates for HTO or arthroplasty. Often, patients suffering in this wide therapeutic gap face a debilitating spiral of disease progression, increasing pain, and decreasing activity until they become suitable arthroplasty patients. An implantable unloading device was evaluated for the treatment of medial knee OA in this patient population. Joint overload has been cited as a contributor to OA onset or progression. In response, the KineSpring® System (Moximed, Inc, USA) has been designed to reduce the load acting on the knee. The unloader is implanted in the subcutaneous tissue without violating the joint capsule, thus preserving the option of future primary arthroplasty. The implant may be particularly useful for young, active patients, given the reversibility of the procedure and the preservation of normal flexibility and range of motion. The KineSpring System was implanted in 79 patients with isolated medial knee OA, and the longest duration exceeds two and a half years. Treated patients were young and obese (mean age: 52 years, range 32–75; mean BMI: > 30 kg/m2, range 21–45). Acute implant success, adverse events, and clinical outcomes using validated patient reported outcomes tools were recorded at baseline, post-op, 2 and 6 weeks, and 3, 6, 12 and 24 months post-op. All centers received ethics committee approvals prior to enrolling patients in the study. Mean surgical time was 72 min (range 45–153 minutes), and all patients were discharged after a few days. Patients recovered rapidly, achieving full weight bearing within 1–2 wks and normal range of motion by 6 weeks. Most patients experienced significant pain relief and functional improvement by six weeks, with results sustained beyond the two-year follow-up visit. WOMAC Pain improved from 43 at baseline to 13 at 2 years (p<0.001), WOMAC Function improved from 43 at baseline to 11 at 2 years (p<0.001), and WOMAC Stiffness improved from 52 at baseline to 18 at 2 years (p<0.001). Patients reported satisfaction with implant and its appearance.Introduction
Methods and Results
Focal chondral defects are thought to contribute to the onset of degenerative changes in cartilage and therefore effective treatments of these lesions are aggressively pursued. A number of options such as bone marrow stimulation, osteochondral autograft transplantation, osteochondral allograft transplantation, and autologous chondrocyte implantation exist. Long-term data regarding efficacy and outcome for some of these approaches seem to suggest that there is still a need for a low-cost, effective treatment that leads to a sustained improvement in symptoms and the formation of hyaline cartilage. artilage autologous implantation system (CAIS) is a surgical method in which hyaline cartilage fragments from a non-weight bearing area in the knee joint are collected and then precipitated onto an absorbable filter that is subsequently placed in the focal chondral defect. The clinical outcome of CAIS was compared with microfracture (MFX) in a pilot study. In an IRB approved protocol patients (n=29) were screened with the intention to treat, randomised (2:1, CAIS:MFX) and followed over a 24 month period. To be included in the study the patient may have up to 2 contained focal, unipolar lesions (≤ ICRS grade 3d and ≤ ICRS Grade IVa OCD lesions of femoral condyles and trochlea with a size between 1 and 10 cm2. There were no differences in the demographics between the two treatment groups. We report 24 month patient-reported outcome (PRO) data using the KOOS-scale. The values (mean±SD) for the Sport&Recreation (S&R) and Quality of Life scales are shown in the figures below. We noted that at 12 months after the intervention CAIS differentiated itself from MFX in that the changes in S&R were different (p<0.05, t-test) at 12, 18, and 24 months. QoL data were different at 18 and 24 months. The other KOOS-subscales in CAIS and MFX were not significantly different at any time point. The data suggest that CAIS led to an improvement in clinical outcomes in the second year post-intervention. It is possible that the improvement of symptoms that we measured may be associated with the formation of hyaline cartilage. Study funded by ATRM and DePuyMITEK.
The Cartilage Autograft Implantation System (CAIS) is being investigated as a potential alternative surgical treatment to provide chondrocyte-based repair in a single procedure for articular cartilage lesion(s) of the knee. CAIS involves preparation and delivery of mechanically morselized, autologous cartilage fragments uniformly dispersed on a 3-dimensional, bio-absorbable scaffold and fixated in the lesion with bio-absorbable staples. CAIS maintains chondrocyte viability and creates increased surface area, which facilitates the outgrowth of embedded chondrocytes onto the scaffold. A proprietary disposable arthroscopic device for harvesting precisely morselized cartilage tissue is used. In an EU pilot clinical study involving 5 countries 25 patients were randomized and treated using a 2:1 schema of CAIS:microfracture (MFX). Subjects returned for follow-up visits at 1 and 3 weeks and then 2, 3, 6, 9, 12, 18 and 24 months and were evaluated using the Knee Injury and Osteoarthritis Outcome Score (KOOS). Outcomes at each time point were analyzed with Students t-test. This study showed that CAIS is safe to use. During the first year, the clinical outcome data in both groups were similar. However, at 18 and 24 months we noted that selected outcome measures were different. At 18 months the Sports &
Recreation values were 50.6 ± 22.70 and 21.3 ± 33.25 (p=0.016) for CAIS and MFX respectively and at 24 months 52.1 ± 27.9 and 26.7 ± 26.2 (p=0.061) for CAIS and MFX respectively. At these same time points the Quality of Life data were 43.0 ± 27.14 and 27.2 ± 29.11 (p=0.2) for CAIS and MFX respectively (18 months) and 45.1 ± 28.07 and 20.5 ± 21.47 (p=0.062) for CAIS and MFX respectively (24 months). While some of the data are not significantly different in this pilot study, taken together they do provide evidence to support the initiation of a more robust clinical trial to investigate efficacy.
The Cartilage Autograft Implantation System (CAIS) is being developed as a potential alternative surgical treatment providing chondrocyte-based repair in a single procedure for articular cartilage lesion(s) of the knee. Two pilot clinical studies were conducted to assess safety and initial performance of the CAIS system. CAIS involves preparation and delivery of mechanically morselized, autologous cartilage uniformly dispersed on a 3-dimensional, bio-absorbable scaffold, and fixated in the defect with bio-absorbable staples. The mechanical fragmentation of cartilage tissue both maintains viability of the chondrocytes and creates increased surface area, which facilitates the outgrowth of embedded chondrocytes onto the scaffold. A proprietary disposable, arthroscopic device for precisely harvesting viable, morselized cartilage tissue was used. Two pilot clinical studies conducted in the EU and US were designed to assess safety and initial performance of the CAIS. The studies treated 53 patients at 10 enrolling sites, with microfracture as a control. Subjects returned for follow-up visits up to 3 years. Subjects were clinically evaluated and interviewed for the occurrence of adverse events and asked to complete clinical outcome questionnaires, Knee Injury and Osteoarthritis Outcome Score (KOOS), regarding disability, function, pain and quality of life. In addition, MRIs were completed at baseline, 3 weeks, and 6, 12, 24, and 36 months. The instrumentation enabled the successful preparation and fixation of morselized autologous cartilage tissue loaded implant in a single intraoperative setting. The CAIS device has demonstrated short-term safety in subjects treated to date. Preliminary data from the US pilot study at 12 months and EU pilot study at 6 months indicate that CAIS is safe and its performance based on KOOS clinical outcomes show improvement over baseline and comparability to microfracture. Additional data must be analyzed regarding long-term safety and performance.
