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Completed

NCT Number: NCT05464485

Hamstring Muscle Strength After ACL Hamstring Reconstruction

Anterior Cruciate Ligament (ACL) reconstructions using hamstring grafts can be performed using one or two hamstring grafts, the semitendinosus (ST) tendon only, or both the semitendinosus and gracilis (ST/G) tendon. As most patients strive to return to sport nine months after reconstruction the purpose of this study was to compare the recovery of hamstring muscle strength during these first nine months after reconstruction using the ST or ST/G tendons.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

About this study

Anterior cruciate ligament (ACL) reconstruction techniques are developing continuously. Studies have shown that anatomical positioning of the femur tunnel is an important predictor for the clinical outcome. This has led to the development of new reconstruction techniques with a more anatomical placement of the femur tunnel: the anteromedial portal (AMP) ACL reconstruction technique and, more recently, the tape locking screw (TLS) ACL reconstruction technique. Multiple retrospective studies have shown that patients have a better short term clinical outcome when the anteromedial portal (AMP) or the tape locking crew (TLS) reconstruction technique is used. At this moment, the most widely used technique is the AMP (performed in approximately 80% of the ACL reconstructions). The TLS technique is widely used in France and the available literature shows good short-term results.

A difference between the AMP and the TLS technique is that the AMP technique uses a double-bundle hamstring graft where the TLS technique uses a single-bundle hamstring graft. The idea is that using a single-bundle hamstring graft causes less hamstring muscle strength deficit. The available literature shows different outcomes of hamstring muscle strength deficit, although, there are no studies found in which the difference in hamstring muscle strength deficit between both techniques directly has been investigated.

Objective: The main objective of this study is to compare the hamstring muscle strength deficit after AMP and TLS reconstruction techniques.

The primary aim of this study is to investigate if there is a difference in hamstring muscle strength deficit at 60°/s flexion in patients with an ACL rupture (18-60 years) who received a tape locking screw ACL reconstruction versus patients who received an anteromedial portal ACL reconstruction 12 weeks after surgery.

The secondary aim of this study is to investigate if there is a difference in muscle strength deficit at 180°/s and 240°/s flexion and extension 12 weeks after surgery and 60°/s, 180°/s and 240°/s flexion and extension 20 weeks after surgery in patients who received a tape locking screw ACL reconstruction versus patients who received an anteromedial portal ACL reconstruction.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient older than 18 years and younger than 60 years old.
  • Mentally competent to understand the informed consent.
  • Patient underwent AMP or TLS ACL reconstruction surgery or will undergo AMP or TLS ACL reconstruction surgery

Exclusion criteria

  • ACL reconstruction surgery older than 12 weeks.
  • Meniscus rupture larger than 25%
  • Indication for meniscal repair.
  • Injury of the collateral ligaments or posterior cruciate ligament
  • History of ACL or meniscal rupture
  • Neurological or systemic disorder that inhibit adequate rehabilitation

Treatment and study plan

ACL hamstring reconstructions using semitendinosus (ST) tendon only

Procedure

ACL reconstruction with a ST tendon graft received a reconstruction according to the Tape Locking Screw technique (FH Industrie, Quimper, France) with a dedicated interference screw

ACL hamstring reconstructions using semitendinosus and gracilis (ST/G) tendon

Procedure

ACL reconstruction with a ST/G tendon graft received a reconstruction with the anteromedial portal technique with endobutton fixation (Smith & Nephew, London, UK).

Primary outcomes

  1. Isokinetic muscle strength deficit

    Time frame: 38 weeks post-surgery

    Comparing isokinetic muscle strength deficit (measured at 60°/s, 180°/s and 240°/s flexion with a the Biodex dynamometer) between both groups

Secondary outcomes

  1. Change in isokinetic muscle strength deficit

    Time frame: 12, 20 and 38 weeks post-surgery

    Comparing the change in isokinetic muscle strength deficit (measured at 60°/s, 180°/s and 240°/s flexion with a the Biodex dynamometer) at 12, 20 and 38 weeks post-surgery

Sponsors and collaborators

Lead sponsor

Isala

Other

Registry information

Official study title

Anterior Cruciate Ligament Hamstring Study: Hamstring Muscle Strength After Anteromedial Portal ACL Reconstruction Versus Tape Locking Screw ACL Reconstruction

Acronym: HAMSTRING

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 19, 2022
Registry last updated
Jul 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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