Clinical trial NCT04071912: Isokinetic Muscular Assessment After ACL Ligamentoplasty: Study of Factors Predictive of Muscle Imbalance.
Official title: Isokinetic Muscular Assessment After ACL Ligamentoplasty: Study of Factors Predictive of Muscle Imbalance.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ACL - Anterior Cruciate Ligament Deficiency
Muscle Weakness
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: INSERM U1075 COMETE, UNICAEN, Caen France
First posted: 2019-08-28
Enrollment: 113
Sex: ALL
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All sports patients included in the sport medicine follow-up protocole with isokinetic muscular assessment at 3-4 months and 6-8 months after ACL reconstruction surgery since January 2016

Brief summary: Despite advances in surgery and rehabilitation, the return to sport after anterior cruciate ligament (ACL) reconstruction surgery remains a major challenge.

challenge. Among the objective criteria retained, the isokinetic muscle strength assessment is an increasingly practiced evaluation and it is recommended to carry out follow-ups at 3-4 months (intermediate) and at 6-8 months (final) after surgery. However, the factors associated with muscle imbalance are uncertain and the threshold values of the intermediate isokinetic strength test (3-4 months) are inconsistent. In a retrospective analysis, the investigators aim to assess the predictive criteria for muscle imbalance after ACL reconstruction surgery.

Detailed description: The investigators aim to retrospectively studied all sports patients who had a muscle evaluation at 3-4 months and 6-8 months after anterior cruciate ligament (ACL) reconstruction surgery since January 2016. The objective criterion were based on the international guidelines for muscle imbalance after ACL surgery and return to sport, as a muscle deficit of less than 20% on knee extensor muslces and less than 10% on knee flexor muscles of the operated knee (vs. healthy).

The investigators will study the predictive analysis of the intermediate muscle strength test to predict the risk of muscle imbalance on the final isokinetic muscle strength assessment. The investigators will also study the individual, injury and surgical criteria associated with muscle imbalance.

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 3-4 months and 6-8 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

Primary outcomes:
measure: Change in Strength
timeFrame: ACL group: Two evaluations on both injured and healthy knees: (1) 3 months after surgery and (2) 7 months after surgery; Routine practice following guidelines
Secondary outcomes:
measure: Individual characteristics
timeFrame: ACL group: Two follow-up medical consultations: (1) 3 months after surgery and (2) 7 months after surgery; Routine practice following guidelines
measure: Injury characteristics
timeFrame: ACL group: Two follow-up medical consultations: (1) 3 months after surgery and (2) 7 months after surgery; Routine practice following guidelines
measure: Surgery characteristics
timeFrame: ACL group: Two follow-up medical consultations: (1) 3 months after surgery and (2) 7 months after surgery; Routine practice following guidelines
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU Caen Normandie
Study officials:
References:
citation: Drigny J, Ferrandez C, Gauthier A, Guermont H, Praz C, Reboursiere E, Hulet C. Knee strength symmetry at 4 months is associated with criteria and rates of return to sport after anterior cruciate ligament reconstruction. Ann Phys Rehabil Med. 2022 Jun;65(4):101646. doi: 10.1016/j.rehab.2022.101646. Epub 2022 Apr 30.