scholarly journals Patient-specific metal implants for focal chondral and osteochondral lesions in the knee; excellent clinical results at 2 years

Author(s):  
Johannes Holz ◽  
Tim Spalding ◽  
Tarek Boutefnouchet ◽  
Pieter Emans ◽  
Karl Eriksson ◽  
...  

Abstract Purpose Surgical treatment options for the management of focal chondral and osteochondral lesions in the knee include biological solutions and focal metal implants. A treatment gap exists for patients with lesions not suitable for arthroplasty or biologic repair or who have failed prior cartilage repair surgery. This study reports on the early clinical and functional outcomes in patients undergoing treatment with an individualised mini-metal implant for an isolated focal chondral defect in the knee. Methods Open-label, multicentre, non-randomised, non-comparative retrospective observational analysis of prospectively collected clinical data in a consecutive series of 80 patients undergoing knee reconstruction with the Episealer® implant. Knee injury and Osteoarthritis Outcome Score (KOOS) and VAS scores, were recorded preoperatively and at 3 months, 1 year, and 2 years postoperatively. Results Seventy-five patients were evaluated at a minimum 24 months following implantation. Two patients had undergone revision (2.5%), 1 declined participation, and 2 had not completed the full data requirements, leaving 75 of the 80 with complete data for analysis. All 5 KOOS domain mean scores were significantly improved at 1 and 2 years (p < 0.001–0.002). Mean preoperative aggregated KOOS4 of 35 (95% CI 33.5–37.5) improved to 57 (95% CI 54.5–60.2) and 59 (95% CI 55.7–61.6) at 12 and 24 months respectively (p < 0.05). Mean VAS score improved from 63 (95% CI 56.0–68.1) preoperatively to 32 (95% CI 24.4–38.3) at 24 months. The improvement exceeded the minimal clinically important difference (MCID) and this improvement was maintained over time. Location of defect and history of previous cartilage repair did not significantly affect the outcome (p > 0.05). Conclusion The study suggests that at 2 years, Episealer® implants are safe with a low failure rate of 2.5% and result in clinically significant improvement. Individualised mini-metal implants with appropriate accurate guides for implantation appear to have a place in the management of focal femoral chondral and osteochondral defects in the knee. Level of evidence IV.

2021 ◽  
Vol 9 (5) ◽  
pp. 232596712110074
Author(s):  
Jakob Ackermann ◽  
Fabio A. Casari ◽  
Christoph Germann ◽  
Lizzy Weigelt ◽  
Stephan H. Wirth ◽  
...  

Background: Autologous matrix-induced chondrogenesis (AMIC) has been shown to result in favorable clinical outcomes in patients with osteochondral lesions of the talus (OLTs). Though, the influence of ankle instability on cartilage repair of the ankle has yet to be determined. Purpose/Hypothesis: To compare the clinical and radiographic outcomes in patients with and without concomitant lateral ligament stabilization (LLS) undergoing AMIC for the treatment of OLT. It was hypothesized that the outcomes would be comparable between these patient groups. Study Design: Cohort study; Level of evidence, 3. Methods: Twenty-six patients (13 with and 13 without concomitant ankle instability) who underwent AMIC with a mean follow-up of 4.2 ± 1.5 years were enrolled in this study. Patients were matched 1:1 according to age, body mass index (BMI), lesion size, and follow-up. Postoperative magnetic resonance imaging and Tegner, American Orthopaedic Foot & Ankle Society (AOFAS), and Cumberland Ankle Instability Tool (CAIT) scores were obtained at a minimum follow-up of 2 years. A musculoskeletal radiologist scored all grafts according to the MOCART (magnetic resonance observation of cartilage repair tissue) 1 and MOCART 2.0 scores. Results: The patients’ mean age was 33.4 ± 12.7 years, with a mean BMI of 26.2 ± 3.7. Patients with concomitant LLS showed worse clinical outcome measured by the AOFAS (85.1 ± 14.4 vs 96.3 ± 5.8; P = .034) and Tegner (3.8 ± 1.1 vs 4.4 ± 2.3; P = .012) scores. Postoperative CAIT and AOFAS scores were significantly correlated in patients with concomitant LLS ( r = 0.766; P = .002). A CAIT score >24 (no functional ankle instability) resulted in AOFAS scores comparable with scores in patients with isolated AMIC (90.1 ± 11.6 vs 95.3 ± 6.6; P = .442). No difference was seen between groups regarding MOCART 1 and 2.0 scores ( P = .714 and P = .371, respectively). Conclusion: Concurrently performed AMIC and LLS in patients with OLT and ankle instability resulted in clinical outcomes comparable with isolated AMIC if postoperative ankle stability was achieved. However, residual ankle instability was associated with worse postoperative outcomes, highlighting the need for adequate stabilization of ankle instability in patients with OLT.


2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 510-510
Author(s):  
Karim Chamie ◽  
Sam Chang ◽  
Mark L. Gonzalgo ◽  
Eugene V. Kramolowsky ◽  
Wade J. Sexton ◽  
...  

510 Background: Patients with NMIBC CIS unresponsive to BCG have limited treatment options. N-803 (Anktiva) is a mutant IL-15-based immunostimulatory fusion protein complex (IL-15RαFc) that promotes proliferation and activation of natural killer (NK) cells and CD8+ T cells, but not regulatory T cells. Phase Ib data in BCG-naive patients with NMIBC demonstrate that intravesical administration of N-803 with BCG induced complete response in all patients, without recurrences for the study duration of 24 months. An open-label, 3 cohort multicenter phase II/III study (QUILT 3.032) of intravesical BCG plus N-803 in patients with BCG-unresponsive high-grade NMIBC (NCT03022825) was opened. We report here the interim analysis of Cohort A, BCG-unresponsive (CIS) [with or without Ta or T1 disease], as of December 2020 data cutoff. Methods: All treated patients received intravesical N-803 plus BCG, consistent with the standard induction/maintenance treatment schedule. The primary endpoint for Cohort A of this phase II/III study is incidence of complete response (CR) of CIS at any time. Results: To date, 80 patients have enrolled in cohort A of this phase II/III trial. Evaluable analysis at this time shows CR rate at any time of 72% (N=51/71); for patients achieving CR, the probability of maintaining a CR for 12 months is 59%, with a median duration of complete response of 19.2 (7.6, 26.4) months. Low-grade treatment related AEs include dysuria, hematuria, and pollakiurua (all 16%), urgency (14%), and bladder spasm (8%), all other AEs were seen at 6% or less. A total of 9 subjects experienced at least 1 treatment emergent SAE (Severe Adverse event), the SAE rate is 1% for any given AE. No treatment emergent SAE’s were considered treatment related. No immune related SAE’s have been seen. To date, 10/80 (12.5%) patients proceeded to cystectomy in this BCG unresponsive population. Conclusions:With a CR rate of 72%, N-803 has met its primary endpoint with 59% probability of CR patients maintaining CR for at least 12 months. With the observed strong efficacy and an SAE rate of 1%, N-803 represents a novel treatment option for BCG unresponsive CIS with a favorable benefit:risk ratio, in a therapeutically challenging disease. Clinical trial information: NCT03022825.


Cartilage ◽  
2020 ◽  
pp. 194760352096116
Author(s):  
Oliver Gottschalk ◽  
Sebastian Felix Baumbach ◽  
Sebastian Altenberger ◽  
Daniel Körner ◽  
Matthias Aurich ◽  
...  

Objective Osteochondral lesions of the talus are common injuries, with one of the leading treatment options being the M-BMS (matrix-augmented bone marrow stimulation) + I/III collagen scaffold. Osteotomy of the medial malleolus is not unusual but presents the risk of malunion or irritation by hardware. The aim of the study was to analyze data from the German Cartilage Society (Knorpelregister DGOU) to evaluate the influence of medial malleolar osteotomy on clinical results of M-BMS + I/III collagen scaffold. Design The ankle module of the Cartilage Register includes a total of 718 patients, while 45 patients met the inclusion criteria. Patients were treated with an M-BMS + I/III collagen scaffold of the medial talus, 30 without and 15 with an osteotomy of the medial malleolus. The follow-up evaluations included FAAM (Foot and Ankle Ability Measure), FAOS (Foot and Ankle Outcome Score), and VAS (visual analogue scale). Results Forty-five patients (22 male, 23 female) aged between 18 and 69 years (mean: 34 years) were included in this study. Between preoperative and 12 months postoperative, we noted a significant improvement in FAAM-ADL (Activity of Daily Living) ( P = 0.004) as well as FAOS-Pain ( P = 0.001), FAOS-Stiffness ( P = 0.047), FAOS-ADL ( P = 0.002), FAOS-Sport ( P = 0.001), and FAOS Quality of Life ( P = 0.009). There was no significant difference between patients who underwent an osteotomy or not. Conclusion The results show a significant improvement in patients’ outcome scores following a M-BMS + I/III collagen scaffold. No statistical difference was noted among those undergoing medial malleolar osteotomy.


2020 ◽  
Vol 8 (7_suppl6) ◽  
pp. 2325967120S0050
Author(s):  
William Bugbee

Objectives: Osteochondral allograft (OCA) transplantation of the knee is an effective treatment for chondral and osteochondral lesions, but graft survivorship and clinical outcomes vary by patient-specific factors. Fresh OCA are often used for large or complex lesions or in the revision cartilage repair setting, but recent literature suggests that the most ideal candidates for OCA transplantation may be young patients with a small lesion on the femoral condyle or trochlea due to osteochondritis dissecans or chondral trauma. The purpose of this study was to assess outcomes following OCA transplantation in a cohort of “ideal” candidates. Methods: We identified 91 patients (97 knees) who underwent primary OCA transplantation for osteochondritis dissecans (88%) or a traumatic chondral injury (12%), were age 30 years or younger, and had an isolated lesion(s) of the femoral condyle or trochlea less than 8 cm2. Mean age was 20 years and 70% were male. Lesions were located on the femoral condyle (85%) or trochlea (15%). One graft was used in 85% of knees and two grafts were used in 15%. Mean total graft area was 5.2 cm2. Evaluation included pain, function, satisfaction, and reoperations. OCA failure was defined as revision allografting or conversion to arthroplasty. Median follow-up was 5.7 years (range 2-17 years). Results: Seventeen knees (18%) underwent reoperations. Two knees (2%) were classified as OCA failures (one revision OCA at 2.7 years and one conversion to unicompartmental arthroplasty at 10.2 years). Survivorship was 99% at 5 and 10 years. Pain and function improved (Table 1.), and 93% of patients were satisfied with the results of the OCA transplantation. Conclusion: In this cohort of “ideal” cartilage repair patients undergoing OCA transplantation, graft survivorship and clinical outcomes were excellent, with high satisfaction, pain relief, and functional improvement. Outcomes were equal or superior to other cartilage repair techniques. [Table: see text]


2017 ◽  
Vol 46 (3) ◽  
pp. 617-622 ◽  
Author(s):  
Kohei Nishitani ◽  
Yasuaki Nakagawa ◽  
Shinichiro Nakamura ◽  
Shogo Mukai ◽  
Shinichi Kuriyama ◽  
...  

Background: Plug protuberance occasionally occurs in osteochondral autologous transplantation (OAT). The incongruity of plugs results in poor clinical outcomes, especially in cases of protuberance. However, a surgical procedure to deal with this problem has not been reported. Purpose/Hypothesis: The purpose was to evaluate the efficacy and safety of cartilage resection of elevated plugs, with the hypothesis that patients whose elevated plugs were resected and leveled would achieve clinical outcomes equivalent to those of patients with flush plugs. Study Design: Cohort study; Level of evidence, 3. Methods: Cases (group P) included 22 patients who underwent OAT of the knee and whose plugs showed protuberance greater than 1 mm that was resected with a scalpel to obtain smooth congruity, while controls (group C) included 22 background-matched patients who did not require plug resection. The International Knee Documentation Committee (IKDC) subjective score, IKDC objective grade, and Japanese Orthopaedic Association score for knee osteoarthritis (JOA knee score) were used preoperatively and at the final follow-up (mean ± SD, 49.3 ± 18.1 months). International Cartilage Repair Society (ICRS) Cartilage Repair Assessment was used to evaluate lesion healing during the second-look arthroscopy. Results: IKDC subjective scores of group C (82.5 ± 11.8) and group P (82.1± 15.1) showed no difference at the final follow-up. On postoperative IKDC objective grading, 86% of group C and 82% of group P patients were graded as “nearly normal” or better ( P = .639). The mean JOA knee scores of group C (90.9 ± 8.9) and group P (90.1 ± 9.5) did not differ significantly ( P = .647). Nine second-look arthroscopies were performed in group C versus 8 in group P, and all patients had plugs that were graded as “nearly normal” or better by the ICRS Cartilage Repair Assessment. Larger plugs tended to be used in those patients who required resection. Conclusion: Resection of the elevated plug surface did not negatively affect patient outcomes in the midterm follow-up period.


2015 ◽  
Vol 5 (1) ◽  
pp. 35-47
Author(s):  
Selene G Parekh ◽  
Mark E Easley ◽  
Samuel B Adams ◽  
Christopher E Gross

ABSTRACT Osteochondral lesions of the talus (OLT) present a formidable treatment challenge to the orthopaedic surgeon. Historical cartilage repair strategies often result in the formation of fibro cartilage leading to suboptimal clinical results. With advances in regenerative medicine, modern surgical techniques are diverse and employ autograft, allograft and tissueengineered constructs for cartilage repair. Fresh and particulated juvenile allograft transplantation have become popular options in the United States. Worldwide, both cellular and acellular tissueengineered constructs are utilized. In all cases, there is still debate as to the optimal cell source and scaffold material and only short term clinical results are available. This article will review these current as well as experimental techniques for cartilage repair of osteochondral lesions of the talus. Adams Jr SB, Gross CE, Tainter DM, Easley ME, Parekh SG. Surgical Management of Osteochondral Lesions of the Talus. The Duke Orthop J 2015;5(1):3547.


2019 ◽  
Vol 7 (2) ◽  
pp. 232596711882526 ◽  
Author(s):  
Youichi Yasui ◽  
Charles P. Hannon ◽  
Ethan J. Fraser ◽  
Jakob Ackermann ◽  
Lorraine Boakye ◽  
...  

Background: Lesion size is a major determinant of treatment strategy for osteochondral lesions of the talus (OLTs). Although magnetic resonance imaging (MRI) is commonly used in the preoperative evaluation of OLTs, the reliability of the MRI measurement compared with the arthroscopic measurement is unknown. Purpose: To compare preoperative lesion size measured on MRI versus intraoperative lesion size measured during arthroscopy. Study Design: Cohort study (diagnosis); Level of evidence, 2. Methods: We retrospectively reviewed a consecutive series of patients treated with bone marrow stimulation for OLTs. The diameter of the lesion was measured at its widest point in 2 planes, and MRI measurements were compared with those made during arthroscopy using a custom-made graduated probe. Results: A total of 39 patients with 45 OLTs were analyzed. Mean ± SD area measurements on MRI were significantly greater than the equivalent arthroscopic measurements (42.2 ± 30.5 vs 28.6 ± 23.1 mm2, respectively; P = .03). Compared with the arthroscopic measurement, MRI overestimated OLT size in 53.3% (24/45) of ankles and underestimated OLT size in 24.4% (11/45). The mean MRI diameter measurement was significantly greater than the arthroscopic measurement in the coronal plane (MRI diameter vs arthroscopic measurement coronal plane, 6.1 ± 2.6 vs 4.9 ± 2.3 mm, P = .03; sagittal plane, 8.0 ± 3.6 vs 6.3 ± 3.6 mm, P = .05). Further, MRI overestimated coronal diameter in 48.9% (22/45) of ankles and underestimated in 26.7% (12/45) compared with the arthroscopic measurement. Similarly, sagittal plane MRI diameter measurements overestimated lesion size in 46.7% (21/45) of ankles and underestimated lesion size in 28.9% (13/45) compared with the arthroscopic findings. Conclusion: In a majority of lesions, MRI overestimated OLT area and diameter compared with arthroscopy. Surgeons should be aware of the discrepancies that can exist between MRI and arthroscopic measurements, as these data are important in making treatment decisions and educating patients.


2020 ◽  
Vol 8 (7) ◽  
pp. 232596712093779
Author(s):  
Lu Bai ◽  
Siyao Guan ◽  
Sanbiao Liu ◽  
Tian You ◽  
Xiaoxiao Xie ◽  
...  

Background: Osteochondral lesions of the talus (OLTs) with large subchondral cysts are challenging to treat. Purpose: To determine the safety and efficacy of autologous chondral grafting and malleolus osteotomy for treating OLTs associated with large subchondral cysts. Study Design: Case series; Level of evidence, 4. Methods: A total of 19 patients underwent autologous chondral grafting and malleolus osteotomy. We obtained the visual analog scale (VAS), American Orthopaedic Foot and Ankle Society (AOFAS) ankle-hindfoot, and magnetic resonance observation of cartilage repair tissue (MOCART) scores at 1 and 2 years postoperatively. The International Cartilage Repair Society (ICRS) score was collected 2 years postoperatively during second-look arthroscopic surgery. Results: In all patients, the osteotomy site healed without nonunion or malunion. Only 1 patient developed joint space narrowing. No donor site complications occurred. The mean AOFAS score significantly improved at 1 year (from 72.8 ± 4.8 preoperatively to 93.7 ± 4.6; t = –13.708; P < .0001). The 1- and 2-year AOFAS scores were similar ( t = –0.755; P = .455), indicating stable improvement. The mean VAS score significantly decreased at 1 year (from 4.68 ± 0.67 preoperatively to 0.47 ± 0.69; t = 18.974; P < .0001). The 1- and 2-year VAS scores were similar ( t = –0.705; P = .455), as were the 1- and 2-year MOCART scores (64.2 ± 7.5 vs 67.4 ± 7.3, respectively; t = –1.312; P = .198). The ICRS scores were as follows: 7 points (abnormal) in 1 (5.2%) patient, 8 to 11 points (nearly normal) in 9 (47.4%) patients, and 12 points (normal) in 9 (47.4%) patients. Conclusion: Osteotomy combined with autologous osteochondral transplantation provided good functional outcomes in patients with OLTs and large subchondral cysts. Second-look arthroscopic surgery showed healthy cartilage healing.


2021 ◽  
Vol 8 (1) ◽  
Author(s):  
Martina Ricci ◽  
Daniele Tradati ◽  
Alessio Maione ◽  
Francesco Mattia Uboldi ◽  
Eva Usellini ◽  
...  

Abstract Purpose The treatment of osteochondral lesions is challenging and no consensus has been established about the best option for restoring both cartilage and subchondral bone. Multilayer collagen-hydroxyapatite scaffolds have shown promising clinical results, but the outcome at a follow-up longer than 5 years still has to be proved. The aim was to evaluate the clinical outcome of patients with a knee isolated osteochondral lesion treated with a biomimetic three-layered scaffold at a minimum 5 years of follow-up. Methods Twenty-nine patients (23 males and 6 females, mean age 31.5 ± 11.4 years) were evaluated retrospectively before surgery, at 1 and 2 years and at last follow-up (FU). Visual Analog Scale (VAS) for pain, International Knee Documentation Committee (IKDC) Subjective Score, Tegner-Lysholm Knee Scoring Scale and Tegner Activity Level Scale were collected. Mean FU was 7.8 ± 2.0 years (min 5.1 - max 11.3). The etiology of the defect was Osteochondritis Dissecans or osteonecrosis (17 vs 12 cases). Results At 12 months FU the IKDC score improved from 51.1 ± 21.7 to 80.1 ± 17.9 (p < 0.01), Tegner Lysholm Score from 59.9 ± 17.3 to 92.5 ± 9.0 (p < 0.01), VAS from 6.1 ± 2.1 to 1.7 ± 2.3 (p < 0.01) and Tegner Activity Level Scale from 1.6 ± 0.5 to 4.9 ± 1.7 (p < 0.01). The results remained stable at 24 months, while at last FU a statistically significant decrease in IKDC, Tegner Lysholm and Tegner Activity Scale was recorded, though not clinically relevant. Patients under 35 achieved statistically better outcomes. Conclusions The use of a cell-free collagen-hydroxyapatite osteochondral scaffold provides substantial clinical benefits in the treatment of knee osteochondral lesions at a minimum follow-up of 5 years, especially in patients younger than 35 years. Level of evidence Level IV.


2020 ◽  
Vol 32 (1) ◽  
Author(s):  
Stephen J. Wallace ◽  
Michael P. Murphy ◽  
Corey J. Schiffman ◽  
William J. Hopkinson ◽  
Nicholas M. Brown

Abstract Background Preoperative radiographic templating for total knee arthroplasty (TKA) has been shown to be inaccurate. Patient demographic data, such as gender, height, weight, age, and race, may be more predictive of implanted component size in TKA. Materials and methods A multivariate linear regression model was designed to predict implanted femoral and tibial component size using demographic data along a consecutive series of 201 patients undergoing index TKA. Traditional, two-dimensional, radiographic templating was compared to demographic-based regression predictions on a prospective 181 consecutive patients undergoing index TKA in their ability to accurately predict intraoperative implanted sizes. Surgeons were blinded of any predictions. Results Patient gender, height, weight, age, and ethnicity/race were predictive of implanted TKA component size. The regression model more accurately predicted implanted component size compared to radiographically templated sizes for both the femoral (P = 0.04) and tibial (P < 0.01) components. The regression model exactly predicted femoral and tibial component sizes in 43.7 and 43.7% of cases, was within one size 90.1 and 95.6% of the time, and was within two sizes in every case. Radiographic templating exactly predicted 35.4 and 36.5% of cases, was within one size 86.2 and 85.1% of the time, and varied up to four sizes for both the femoral and tibial components. The regression model averaged within 0.66 and 0.61 sizes, versus 0.81 and 0.81 sizes for radiographic templating for femoral and tibial components. Conclusions A demographic-based regression model was created based on patient-specific demographic data to predict femoral and tibial TKA component sizes. In a prospective patient series, the regression model more accurately and precisely predicted implanted component sizes compared to radiographic templating. Level of evidence Prospective cohort, level II.


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