Clinical trial NCT05264597: Hamstring Stiffness After Anterior Cruciate Ligament Reconstruction
Official title: Hamstring Stiffness After Anterior Cruciate Ligament Reconstruction: a Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ACL Injury
Stiffness of Knee, Not Elsewhere Classified
Sport Injury
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 135
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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)


Eligibility criteria: 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

Primary outcomes:
measure: Change in passive hamstring stiffness
timeFrame: 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)
measure: Change in Strength
timeFrame: 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:
measure: Individual characteristics
timeFrame: 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)
measure: Surgery characteristics
timeFrame: ACLR group only: one follow-up medical consultations at 4 months after surgery
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU Caen Normandie
Study officials:
References: