Isokinetic Muscular Assessment After ACL Ligamentoplasty: Study of Factors Predictive of Muscle Imbalance.

Muscle Weakness Clinical Trial

— PREDICT-ACL  

Official title:

Isokinetic Muscular Assessment After ACL Ligamentoplasty: Study of Factors Predictive of Muscle Imbalance.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04071912
• Other study ID #: PREDICT-ACL
• Status: Completed
• Start date: October 1, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: July 2020
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• ACL - Anterior Cruciate Ligament Deficiency
• Muscle Weakness

Locations

Country	Name	City	State
France	CHU Caen Normandie	Caen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Caen	INSERM U1075 COMETE, UNICAEN, Caen France

Country where clinical trial is conducted

France, 

Outcome

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