NCT04071912

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

2 months

First QC Date

August 26, 2019

Last Update Submit

July 13, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Individual characteristics

    ACL group: Two follow-up medical consultations: (1) 3 months after surgery and (2) 7 months after surgery; Routine practice following guidelines

  • Injury characteristics

    ACL group: Two follow-up medical consultations: (1) 3 months after surgery and (2) 7 months after surgery; Routine practice following guidelines

  • Surgery characteristics

    ACL group: Two follow-up medical consultations: (1) 3 months after surgery and (2) 7 months after surgery; Routine practice following guidelines

Study Arms (1)

ACL

All sports patients who had a muscle evaluation at 3-4 months and 6-8 months after ACL ligamentoplasty since January 2016

Eligibility Criteria

Age16 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Caen Normandie

Caen, 14000, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Resident PM&R and Sport departments MD, MSc

Study Record Dates

First Submitted

August 26, 2019

First Posted

August 28, 2019

Study Start

October 1, 2019

Primary Completion

December 1, 2019

Study Completion

February 1, 2020

Last Updated

July 14, 2020

Record last verified: 2020-07

Locations