Hamstring Stiffness After Anterior Cruciate Ligament Reconstruction

NCT05264597 | Completed

• 1 other identifier: ACLSTIFF 1452
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

The role of hamstring has been studied in anterior cruciate ligament (ACL) injury prevention, mainly to counteract the anterior tibial translation , especially when contracting eccentrically, but also with passive stiffness. However, little is known about the passive hamstring stiffness after ACL reconstruction (ACLR). The primary objective of this study is to evaluate the passive stiffness of hamstring muscles after ACLR by using an isokinetic device. Secondary, we aimed to test the individual and surgical characteristics associated with hamstring stiffness and the impact of hamstring stiffness on RTS and knee re-injury. The hypotheses are that hamstring stiffness will be lower in the ACLR leg compared to the uninjured leg and to healthy individuals. Also, we hypothesized that hamstring stiffness will be lower after hamstring autograft compared to patellar tendon autograft and will increase progressively after ACLR to be symmetrical at the time for RTS. Also, we hypothesized that hamstring stiffness could be associated with better outcomes at RTS (RTS at same level and lower re-injury rates)

Conditions

ACL Injury; Stiffness of Knee, Not Elsewhere Classified; Sport Injury

Outcome Measures

Primary Outcomes (2)

• Change in passive hamstring stiffness

  Measurement of knee flexors stiffness (in newton.meter per degree, Nm/°) on isokinetic dynamometer.

  ACLR group: Two evaluations on both injured and healthy knees: (1) 4 months after surgery and (2) 8 months after surgery; Control group:one evaluation at a single point in time through study completion (an average of one year)

• Change in Strength

  Measurement of knee extensors and flexors peak strength (in newton.meter, Nm) on isokinetic dynamometer.

  ACLR group: Two evaluations on both injured and healthy knees: (1) 4 months after surgery and (2) 8 months after surgery; Control group:one evaluation at a single point in time through study completion (an average of one year)

Secondary Outcomes (2)

• Individual characteristics

  ACLR group: Two follow-up medical consultations: (1) 4 months after surgery and (2) 2 years after the surgery for return to sport and reinjury; Control group:one evaluation at a single point in time through study completion (an average of one year)

• Surgery characteristics

  ACLR group only: one follow-up medical consultations at 4 months after surgery

Study Arms (2)

ACLR group

Patients after ACLR with a standardized followup in the Sport Medicine department

Control group

Age and sexe-matches volunteers

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

ACLR group: All patients included in the sport medicine follow-up protocole with isokinetic muscular assessment at 4 months and 8 months after ACL reconstruction surgery since January 2017 Control group: Age- and sexe- matched healthy volunteers with regular sport practice

You may qualify if:

• Patients who have had an ACL reconstruction surgery (isolated or associated with other meniscal or ligamentary surgery)
• Patient included in the sport medicine follow-up protocole with intermediate and final isokinetic muscular assessment at 4 months and 8 mnths after surgery respectively
• Patient who received the information form

You may not qualify if:

• Patient who did not participate in all follow-up consultations and isokinetic muscular assessments
• Cognitive or sensory impairment making it impossible to understand the information form
• Neurological, traumatic or osteoarticular history responsible for muscle imbalance prior to surgery
• Previous severe injury on the ipsilateral or contralateral knee
• Recent muscle damage
• ACL reinjury ( graft failure)
• Patient with genu flexum, or constant flexed knee at 3 months after surgery
• Informed consent not obtained

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

CHU Caen Normandie

Caen, 14000, France

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 3, 2022
• Study Start: January 1, 2017
• Primary Completion: February 1, 2020
• Study Completion: October 1, 2021
• Last Updated: March 26, 2025

Record last verified: 2023-02

Locations

FR (1)