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Not yet recruiting NCT05270551

The Effect of Accelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction With and Without Suture Tape Reinforcement

No phase Interventional ACL Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ACL Reconstruction.
Who it may be relevant to
Registry conditions: ACL Injury. Basic parameters: 15 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The aim of our study is to evaluate the effect of accelerated rehabilitation post ACL reconstruction with and without augmentation on graft healing and return to normal activity clinically by scoring system and radiologically.

Detailed description

ACL reconstruction is the most commonly performed knee ligament reconstruction and employs a variety of surgical techniques. However, despite high success rates, it is still challenged by residual laxity and graft rupture.

While the majority of patients who undergo ACLR will have good to excellent results, a subset of patients is at a higher risk for graft failure. For those that require revision surgery, the second operation often fails. Anterior cruciate ligament injuries account for 50% of knee ligament injuries for high school-aged adults.

The most commonly used autografts for ACLR are the hamstring tendons (HT) and the bone-patellar tendon-bone (BPTB). However, questions remain about how patients with either an HT or a BPTB autograft recover knee muscle strength postoperatively.

To help address and prevent future ACL failures, new repair and reconstruction techniques have been employed that incorporate suture augmentation. The goal of augmentation is to protect the newly repaired or reconstructed ligament during rehabilitation.

Despite advances in anterior cruciate ligament (ACL) reconstruction surgical techniques and rehabilitation, recent studies report that between 20% to 50% of those with ACL reconstruction do not return to the same sports after surgery and 10% to 70% of those who resume preinjury sports participate at a reduced level or with significant functional impairments.

Anecdotal evidence from patient report and clinical observation suggests that an inability to return to sports after ACL reconstruction can be partially attributed to a fear of reinjuring the knee.

Interventions

  • Procedure ACL Reconstruction
    All participants will do ACL reconstruction with and without Augmentation and will receive Accelerated rehabilitation program

Primary outcome measures

  • Clinical outcome [Time frame: 1 year follow up]
  • Clinical outcome [Time frame: 1 year follow up]
Secondary outcome measures (1)
  • Radiological outcome [Time frame: 6 months follow up]

Eligibility criteria

Inclusion criteria

  • Age from 15 to 50 years old.
  • With or without meniscal injury.
  • Isolated ACL injury without any other ligament injury.
  • Recent and chronic injury.

Exclusion criteria

  • Multiligament injury.
  • Deformed knee (Genu varus or valgus).
  • Previous ACL reconstruction or repair.
  • Older than 50 years old and younger than 15 years old.
  • Failed ACL reconstruction or repair -

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Schlumberger M, Schuster P, Schulz M, Immendorfer M, Mayer P, Bartholoma J, Richter J. Traumatic graft rupture after primary and revision anterior cruciate ligament reconstruction: retrospective analysis of incidence and risk factors in 2915 cases. Knee Surg Sports Traumatol Arthrosc. 2017 May;25(5):1535-1541. doi: 10.1007/s00167-015-3699-0. Epub 2015 Sep 26. PMID 26410092
  • Riediger MD, Stride D, Coke SE, Kurz AZ, Duong A, Ayeni OR. ACL Reconstruction with Augmentation: a Scoping Review. Curr Rev Musculoskelet Med. 2019 Jun;12(2):166-172. doi: 10.1007/s12178-019-09548-4. PMID 30945237
  • Cristiani R, Mikkelsen C, Wange P, Olsson D, Stalman A, Engstrom B. Autograft type affects muscle strength and hop performance after ACL reconstruction. A randomised controlled trial comparing patellar tendon and hamstring tendon autografts with standard or accelerated rehabilitation. Knee Surg Sports Traumatol Arthrosc. 2021 Sep;29(9):3025-3036. doi: 10.1007/s00167-020-06334-5. Epub 2020 Oct 31. PMID 33128587
  • Smith PA, Bley JA. Allograft Anterior Cruciate Ligament Reconstruction Utilizing Internal Brace Augmentation. Arthrosc Tech. 2016 Oct 10;5(5):e1143-e1147. doi: 10.1016/j.eats.2016.06.007. eCollection 2016 Oct. PMID 28224069
  • Chmielewski TL, Jones D, Day T, Tillman SM, Lentz TA, George SZ. The association of pain and fear of movement/reinjury with function during anterior cruciate ligament reconstruction rehabilitation. J Orthop Sports Phys Ther. 2008 Dec;38(12):746-53. doi: 10.2519/jospt.2008.2887. PMID 19047767
  • Beynnon BD, Johnson RJ, Abate JA, Fleming BC, Nichols CE. Treatment of anterior cruciate ligament injuries, part 2. Am J Sports Med. 2005 Nov;33(11):1751-67. doi: 10.1177/0363546505279922. PMID 16230470
  • Dean AG. OpenEpi: open source epidemiologic statistics for public health, version 2.3. 1. http://www. openepi. com. 2010.

Identifiers

NCT: NCT05270551 · ACL Recon. rehabilitation

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗