Mortazavi Seyed Mohammad Javad, Abbaspour Aziz, Seyedtabaei Seyed Mohammad Milad, Saberi Sadegh, Khabiri Seyyed Saeed
Department of Orthopedic Surgery, Joint Reconstruction Research Center, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Keshavarz Boulevard, Tehran, 1419733141, Iran.
Orthopedic Oncologic Department, Cancer Institute, Tehran University of Medical Sciences, Tehran, Iran.
Eur J Orthop Surg Traumatol. 2025 Mar 3;35(1):85. doi: 10.1007/s00590-025-04221-8.
Transfemoral amputees face significant functional limitations with traditional socket prostheses. This study evaluates the efficacy and safety of the OPRA (Osseointegrated Prostheses for the Rehabilitation of Amputees) implant system in improving the quality of life for these patients.
A retrospective study was conducted on 22 transfemoral amputees (20 male, 2 female; mean age 44.6 years) who underwent OPRA implant surgery between 2019 and 2021. Patients were assessed preoperatively and followed for two years post-surgery. Outcomes were measured using the Questionnaire for Persons with a Transfemoral Amputation (Q-TFA), pain scores, and complication rates.
At two-year follow-up, significant improvements were observed in Q-TFA scores for prosthetic use (30.41 ± 10.90 to 87.68 ± 11.42, p < 0.001), mobility (44.36 ± 15.57 to 71.45 ± 13.72, p < 0.001), problem score (52.40 ± 10.22 to 25.81 ± 9.66, p < 0.001), and global score (43.45 ± 10.87 to 74.95 ± 21.82, p < 0.001). Mean daily prosthesis usage increased from 3.77 ± 2.59 to 13.43 ± 3.76 h (p < 0.001). Complications included minor discharge (67.5%), significant discharge requiring surgical intervention (13.6%), prosthesis removal (9%), and periprosthetic fracture (4.5%).
The OPRA implant system significantly improved functional outcomes and quality of life for transfemoral amputees over two years. While complication rates were notable, most were manageable with conservative treatment. These findings suggest that osseointegrated prostheses offer a promising alternative to socket prostheses for suitable candidates, though further research with larger cohorts is warranted to confirm long-term efficacy and safety.
经股截肢者使用传统的接受腔假肢面临显著的功能限制。本研究评估OPRA(截肢者康复骨整合假肢)植入系统在改善这些患者生活质量方面的有效性和安全性。
对2019年至2021年间接受OPRA植入手术的22名经股截肢者(20名男性,2名女性;平均年龄44.6岁)进行了一项回顾性研究。对患者进行术前评估,并在术后随访两年。使用经股截肢者问卷(Q-TFA)、疼痛评分和并发症发生率来衡量结果。
在两年的随访中,观察到假肢使用的Q-TFA评分(从30.41±10.90提高到87.68±11.42,p<0.001)、活动能力(从44.36±15.57提高到71.45±13.72,p<0.001)、问题评分(从52.40±10.22提高到25.81±9.66,p<0.001)和总体评分(从43.45±10.87提高到74.95±21.82,p<0.001)有显著改善。平均每日假肢使用时间从3.77±2.59小时增加到13.43±3.76小时(p<0.001)。并发症包括轻微渗液(67.5%)、需要手术干预的严重渗液(13.6%)、假肢移除(9%)和假体周围骨折(4.5%)。
OPRA植入系统在两年内显著改善了经股截肢者的功能结果和生活质量。虽然并发症发生率较高,但大多数通过保守治疗可以控制。这些发现表明,对于合适的候选人,骨整合假肢为接受腔假肢提供了一种有前景的替代方案,不过需要进一步开展更大样本量的研究来证实其长期有效性和安全性。