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Completed

NCT Number: NCT05264597

Hamstring Stiffness After Anterior Cruciate Ligament Reconstruction

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)

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Key information

Conditions

ACL Injury Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Sport Injury Stiffness of Knee, Not Elsewhere Classified Wounds and Injuries

Age range

16 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Caen Normandie

Caen, 14000, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Change in passive hamstring stiffness

    Time frame: 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)

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

  2. Change in Strength

    Time frame: 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)

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

Secondary outcomes

  1. Individual characteristics

    Time frame: 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)

    Personal characteristics recorded in the medical report as age, gender, type of sport and sport level of practice and return to sport after the surgery and severe reinjury on the operated knee or contralateral knee.

  2. Surgery characteristics

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

    Surgery characteristics recorded in the medical report as the type of surgery, the surgery duration and tourniquet time

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

Hamstring Stiffness After Anterior Cruciate Ligament Reconstruction: a Prospective Study

Acronym: ACLSTIFF

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Mar 3, 2022
Registry last updated
Mar 26, 2025

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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