Hamstring Stiffness After Anterior Cruciate Ligament Reconstruction (ACLSTIFF)

Hamstring Stiffness After Anterior Cruciate Ligament Reconstruction: a Prospective Study

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)

Study Overview

• Status: Completed
• Conditions: Sport Injury; ACL Injury; Stiffness of Knee, Not Elsewhere Classified

• Study Type: Observational
• Enrollment (Actual): 135

Contacts and Locations

Study Locations

• France
  • Caen, France, 14000
    • CHU Caen Normandie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 50 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
ACLR group; Patients after ACLR with a standardized followup in the Sport Medicine department
Control group; Age and sexe-matches volunteers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Individual characteristics	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.	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	Surgery characteristics recorded in the medical report as the type of surgery, the surgery duration and tourniquet time	ACLR group only: one follow-up medical consultations at 4 months after surgery

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Collaborators: INSERM U1075 COMETE, UNICAEN, Caen France

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): February 1, 2020
• Study Completion (ACTUAL): October 1, 2021

Study Registration Dates

• First Submitted: February 22, 2022
• First Submitted That Met QC Criteria: February 22, 2022
• First Posted (ACTUAL): March 3, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Leg Injuries; Knee Injuries; Wounds and Injuries; Anterior Cruciate Ligament Injuries; Athletic Injuries
• Other Study ID Numbers: ACLSTIFF 1452

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No