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半月板部分缺损行胶原蛋白半月板植入术后患者长期报告结局指标的预测因素

Predictors of Long-term Patient-Reported Outcome Measures After Collagen Meniscal Implant for Partial Meniscal Defects.

作者信息

Grassi Alberto, Lucidi Gian Andrea, Di Paolo Stefano, Pierangeli Andrea, Agostinone Piero, Dal Fabbro Giacomo, Pizza Nicola, Zaffagnini Stefano

机构信息

Clinica Ortopedica e Traumatologica II, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.

Dipartimento di Scienze per la Qualità della Vita QuVi, Università di Bologna, Italy.

出版信息

Orthop J Sports Med. 2024 Jul 25;12(7):23259671241254395. doi: 10.1177/23259671241254395. eCollection 2024 Jul.

Abstract

BACKGROUND

Collagen meniscal implant (CMI) is considered an effective procedure for reducing knee pain and improving knee function after previous meniscectomy. Nevertheless, the current knowledge regarding long-term patient reported-outcome measures after CMI is limited.

PURPOSE

To evaluate clinical outcomes, reoperations, and failures of CMI at a minimum 10-year follow-up.

STUDY DESIGN

Case series; Level of evidence, 4.

METHODS

Consecutive patients who underwent CMI at a single institution were screened for eligibility. Inclusion criteria for the present study were (1) medial or lateral CMI; (2) isolated or combined procedure with anterior cruciate ligament reconstruction, knee osteotomy, or cartilage treatment; and (3) follow-up between 10 and 15 years. Demographics and surgical details were obtained via chart review. Patients were asked if they were satisfied with the procedure and were evaluated with the Lysholm score, Knee injury and Osteoarthritis Outcome Score (KOOS), visual analog scale for pain, and Tegner score at the final follow-up. Cases requiring partial or total scaffold removal for any reason (including scaffold breakage, infection, or surgery for osteoarthritis progression) were considered surgical failure. Survival analysis was performed with Kaplan-Meier curve, and clinical scores were analyzed based on the Patient Acceptable Symptom State (PASS).

RESULTS

A total of 92 patients (mean age, 42.2 years were included in the analysis. A significant improvement in all clinical scores was reported between the preoperative evaluation and the last follow-up. A chondropathy with Outerbridge grade ≥3 was associated with significantly overall lower clinical scores, while a timing from meniscectomy to CMI of ≥5 years determined more pain at rest and reduced Quality of Life in the KOOS subscale. No significant difference was found in terms of clinical scores between patients undergoing isolated and combined procedures. At the final follow-up, the mean Lysholm score was 76.3 points. In total, 12 cases (13%) were considered surgical failures. Sixteen patients (17%) did not reach PASS for the Lysholm score, with a total of 28 cases (30%) classified as clinical failures. Overall, 19% (KOOS Pain) and 40% (KOOS Symptoms) of patients did not achieve the PASS in the KOOS subscales. Chondropathy with Outerbridge grade ≥3 was associated with a higher risk of not achieving the PASS in all the KOOS subscales, while age at surgery of ≥45 years resulted in a lower risk of not achieving PASS in the Pain subscale. At the last follow-up, 63% of patients were still involved in sports activity, with 41% at the same or higher level. Finally, 80% of the patients were satisfied with the procedure.

CONCLUSION

Up to 10 years after surgery, around 70% of the patients who underwent CMI reported satisfactory clinical results, with clinical subjective scores still higher compared with the preoperative evaluation. Overall, 30% of cases were considered clinical failures, with 13% considered surgical failures and 17% not meeting the PASS for the Lysholm score. In addition, cartilage status and time from meniscectomy were shown to have a negative impact on the outcomes, while an age ≥45 years was associated with less pain. There was no clinical difference between patients who underwent isolated CMI or combined procedures.

摘要

背景

胶原蛋白半月板植入物(CMI)被认为是一种有效的手术方法,可减轻既往半月板切除术后的膝关节疼痛并改善膝关节功能。然而,目前关于CMI术后长期患者报告结局指标的了解有限。

目的

在至少10年的随访中评估CMI的临床结局、再次手术情况及失败率。

研究设计

病例系列;证据等级,4级。

方法

对在单一机构接受CMI手术的连续患者进行资格筛选。本研究的纳入标准为:(1)内侧或外侧CMI;(2)与前交叉韧带重建、膝关节截骨术或软骨治疗的单独或联合手术;(3)随访10至15年。通过病历回顾获取人口统计学和手术细节。询问患者对手术是否满意,并在末次随访时采用Lysholm评分、膝关节损伤和骨关节炎结局评分(KOOS)、疼痛视觉模拟量表及Tegner评分进行评估。因任何原因(包括支架断裂、感染或因骨关节炎进展而进行的手术)需要部分或全部取出支架的病例被视为手术失败。采用Kaplan-Meier曲线进行生存分析,并根据患者可接受症状状态(PASS)分析临床评分。

结果

共有92例患者(平均年龄42.2岁)纳入分析。术前评估与末次随访之间所有临床评分均有显著改善。Outerbridge分级≥3级的软骨病与总体临床评分显著降低相关,而半月板切除至CMI的时间≥5年则导致静息时疼痛更明显,且KOOS子量表中的生活质量降低。单独手术和联合手术患者的临床评分无显著差异。末次随访时,平均Lysholm评分为76.3分。共有12例(13%)被视为手术失败。16例(17%)患者Lysholm评分未达到PASS,共有28例(30%)被归类为临床失败。总体而言,19%(KOOS疼痛)和40%(KOOS症状)的患者在KOOS子量表中未达到PASS。Outerbridge分级≥3级的软骨病与所有KOOS子量表中未达到PASS的较高风险相关,而手术年龄≥45岁则导致疼痛子量表中未达到PASS的风险较低。在末次随访时,63%的患者仍参与体育活动,其中41%处于相同或更高水平。最后,80%的患者对手术满意。

结论

术后长达10年,接受CMI手术的患者中约70%报告临床结果满意,临床主观评分仍高于术前评估。总体而言, 30%的病例被视为临床失败,13%被视为手术失败,17%未达到Lysholm评分的PASS。此外,软骨状态和半月板切除后的时间对结局有负面影响,而年龄≥45岁与疼痛减轻相关。单独接受CMI手术或联合手术的患者之间无临床差异。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/80d7/11273561/f203417b9441/10.1177_23259671241254395-fig1.jpg

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