Hamstring Muscle Strength After ACL Hamstring Reconstruction

Anterior Cruciate Ligament Rupture Clinical Trial

— HAMSTRING  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05464485
• Other study ID #: 60029.075.16
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: July 1, 2018

Study information

• Verified date: July 2022
• Source: Isala
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Rupture
• Rupture

Intervention

Procedure:
• ACL hamstring reconstructions using semitendinosus (ST) tendon only
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
ACL reconstruction with a ST/G tendon graft received a reconstruction with the anteromedial portal technique with endobutton fixation (Smith & Nephew, London, UK).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Isala

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Isokinetic muscle strength deficit	Comparing isokinetic muscle strength deficit (measured at 60°/s, 180°/s and 240°/s flexion with a the Biodex dynamometer) between both groups	38 weeks post-surgery
Secondary	Change in isokinetic muscle strength deficit	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	12, 20 and 38 weeks post-surgery