Muscle Weakness Clinical Trial
— PREDICT-ACLOfficial title:
Isokinetic Muscular Assessment After ACL Ligamentoplasty: Study of Factors Predictive of Muscle Imbalance.
Verified date | July 2020 |
Source | University Hospital, Caen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 113 |
Est. completion date | February 1, 2020 |
Est. primary completion date | December 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 55 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | CHU Caen Normandie | Caen |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Caen | INSERM U1075 COMETE, UNICAEN, Caen France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Strength | Measurement of knee extensors and flexors peak strength (in newton.meter, Nm) on isokinetic dynamometer. | 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 | 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 | ACL group: Two follow-up medical consultations: (1) 3 months after surgery and (2) 7 months after surgery; Routine practice following guidelines | |
Secondary | Injury characteristics | Injury characteristics recorded in the medical report as the type of injury (ACL only, ACL and meniscus, ACL with other ligament injury, recurrent ACL injury) the time before surgery, the type of rehabilitation before and after surgery | ACL group: Two follow-up medical consultations: (1) 3 months after surgery and (2) 7 months after surgery; Routine practice following guidelines | |
Secondary | Surgery characteristics | Surgery characteristics recorded in the medical report as the type of surgery, the surgery duration and tourniquet time | ACL group: Two follow-up medical consultations: (1) 3 months after surgery and (2) 7 months after surgery; Routine practice following guidelines |
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