Hamstring Muscle Strength After ACL Hamstring Reconstruction

NCT05464485 | Completed

• 1 other identifier: 60029.075.16
• Study Type: observational
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Anterior Cruciate Ligament Rupture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in isokinetic muscle strength deficit

  12, 20 and 38 weeks post-surgery

Study Arms (2)

ACL hamstring reconstructions using semitendinosus (ST) tendon only

Procedure: ACL hamstring reconstructions using semitendinosus (ST) tendon only

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

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

Interventions

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 (ST) tendon only

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).

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients will be recruited from the Orthopaedic outpatient clinic of the Isala in Zwolle if the patient has an ACL rupture and if there is an indication for surgical reconstruction with the AMP or TLS ACL reconstruction technique or at the (standard) 6 weeks follow-up appointment after AMP or TLS ACL reconstruction surgery

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Isala: lead

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 10, 2022
• First Posted: July 19, 2022
• Study Start: January 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share