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临床试验/NCT07564336
NCT07564336已完成不适用

Achilles Tendon Allografts With and Without InternalBrace Augmentation for Anterior Cruciate Ligament Revision Surgery: A Randomized Controlled Pilot Trial

Medical University of Graz1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2017年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
试验地点
1
主要终点
International Knee Documentation Committee Score

研究概览

简要总结

This study evaluated outcomes after revision anterior cruciate ligament reconstruction using Achilles tendon allografts with a calcaneal bone block, with or without additional InternalBrace augmentation. Revision ACL reconstruction is often more complex than primary ACL reconstruction because previous surgery may leave widened bone tunnels or bone defects. Achilles tendon allografts with attached bone blocks may help address these defects and allow reconstruction in a single surgical procedure.

Participants with MRI-confirmed ACL graft re-tear and clinical knee instability were randomized to undergo revision ACL reconstruction either with InternalBrace augmentation or without InternalBrace augmentation. Clinical outcomes, patient-reported knee function, health-related quality of life, and MRI findings were assessed during 13 months of follow-up. The study was designed as a prospective randomized controlled pilot trial to compare whether additional InternalBrace augmentation improved functional, radiographic, or quality-of-life outcomes after revision ACL surgery.

详细描述

Anterior cruciate ligament revision surgery remains challenging and may have less predictable outcomes than primary ACL reconstruction. In revision cases, prior bone tunnels and bone defects can complicate graft fixation. Achilles tendon allografts with calcaneal bone blocks provide a reliable graft configuration and may help fill pre-existing bone defects during a one-stage revision procedure. InternalBrace augmentation is intended to provide additional support to the reconstructed ligament during the healing period, but clinical evidence for its use with allograft ACL revision surgery is limited.

This prospective, randomized controlled pilot study enrolled patients from February 2017 to September 2020 at the Medical University of Graz. Eligible participants had MRI-confirmed re-tear of the ACL graft and clinical and patient-reported knee instability. Patients with advanced associated lesions requiring reconstruction or prolonged restricted weight bearing, signs of infection, advanced osteoarthritis, or neuromuscular disease were excluded. For all included participants, the procedure was the first revision surgery on the affected knee. The study was approved by the Ethics Committee of the Medical University of Graz, and written informed consent was obtained before participation.

All participants underwent revision ACL reconstruction using an Achilles tendon allograft with a calcaneal bone block. Participants were randomized in a 1:1 ratio to receive either additional InternalBrace augmentation or no InternalBrace augmentation. The InternalBrace group received a non-resorbable polyethylene FiberTape fixed separately and independently from the ACL graft. Apart from the additional InternalBrace fixation in one group, the surgical technique and postoperative rehabilitation protocol were the same for all participants.

Clinical and patient-reported outcomes were assessed preoperatively and at 6 weeks, 12 weeks, 6 months, and 13 months after surgery. Outcome measures included the International Knee Documentation Committee score, Lysholm Knee Questionnaire, Tegner Activity Scale, Knee Injury and Osteoarthritis Outcome Score, and Short Form-36. MRI scans were performed before surgery and 13 months after surgery to assess graft appearance, graft tightness, graft signal, ligament signs at the femoral and tibial tunnel insertions, and tunnel size.

The final analyzed study population included 30 participants, with 16 participants in the InternalBrace group and 14 participants in the non-InternalBrace group. Overall, clinical and patient-reported outcomes improved during follow-up. At the final 13-month follow-up, there were no clinically relevant differences between the InternalBrace and non-InternalBrace groups. Postoperative MRI showed elongated or insufficient ACL allografts in 15 of 30 participants, without significant differences between groups. The study concluded that ACL revision surgery using Achilles tendon allografts with bone blocks resulted in improved clinical outcomes at 13 months, but additional InternalBrace augmentation did not improve objective or subjective outcomes in this pilot trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Surgeons could not be blinded because of the nature of the intervention. Postoperative MRI scans were evaluated by two senior musculoskeletal radiologists, and disagreements were resolved by consensus.

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • MRI-confirmed re-tear of the anterior cruciate ligament.
  • Clinical knee instability.
  • Patient-reported knee instability.
  • Planned first revision anterior cruciate ligament reconstruction of the affected knee.
  • Ability to undergo the standardized postoperative rehabilitation protocol.
  • Written informed consent for study participation and use of study data.

排除标准

  • Advanced associated knee lesions, such as pronounced meniscal tears or cartilage defects, requiring reconstruction or prolonged reduced weight bearing.
  • Signs of infection.
  • Advanced-stage osteoarthritis.
  • Neuromuscular disease.
  • Previous revision surgery on the affected knee.

研究组 & 干预措施

InternalBrace Augmentation

Experimental

Participants underwent revision anterior cruciate ligament reconstruction using an Achilles tendon allograft with calcaneal bone block and additional InternalBrace augmentation. The InternalBrace consisted of non-resorbable polyethylene FiberTape fixed separately and independently from the ACL allograft.

干预措施: Revision ACL Reconstruction With Achilles Tendon Allograft and InternalBrace Augmentation (Procedure)

No InternalBrace Augmentation

Active Comparator

Participants underwent revision anterior cruciate ligament reconstruction using an Achilles tendon allograft with calcaneal bone block without additional InternalBrace augmentation. Apart from the InternalBrace augmentation, the surgical technique and postoperative rehabilitation protocol were the same as in the InternalBrace group.

干预措施: Revision ACL Reconstruction With Achilles Tendon Allograft Without InternalBrace Augmentation (Procedure)

结局指标

主要结局

International Knee Documentation Committee Score

时间窗: Preoperative baseline to 13 months after surgery

The International Knee Documentation Committee score was used to assess patient-reported knee symptoms, function, and sports activity after revision anterior cruciate ligament reconstruction. Scores range from 0 to 100, with higher scores indicating better knee function.

次要结局

  • Lysholm Knee Questionnaire Score(Preoperative baseline to 13 months after surgery)
  • Tegner Activity Scale Score(Preoperative baseline to 13 months after surgery)
  • Knee Injury and Osteoarthritis Outcome Score(Preoperative baseline to 13 months after surgery)
  • MRI Assessment of ACL Allograft Tightness(13 months after surgery)
  • MRI Assessment of Femoral and Tibial Tunnel Size(13 months after surgery)
  • Short Form-36 Mental Component Summary Score(Preoperative baseline to 13 months after surgery)
  • Short Form-36 Physical Component Summary Score(Preoperative baseline to 13 months after surgery)

研究者

发起方
Medical University of Graz
申办方类型
Other
责任方
Sponsor

研究点 (1)

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