PREDICT-ACLv2: Association Between 4-Month Isokinetic Testing Measures and Second Knee Injuries After Primary Anterior Cruciate Ligament Reconstruction

Sponsor
University Hospital, Caen (Other)
Overall Status
Completed
CT.gov ID
NCT05897970
Collaborator
(none)
150
1
24
6.3

Study Details

Study Description

Brief Summary

Anterior cruciate ligament (ACL) is a frequent and disabling injury in athletes. Most of the time, ACL reconstruction (ACLR) is consider for regaining function and returning to preinjury sports while reducing the risk of secondary injuries. However, the risk of secondary severe knee injury is increased after ACLR, especially in athletes returning to strenuous activities. If strength symmetry is considered as an important factor in the Return-to-sport (RTS) decision, there is conflicting data about the association between strength symmetry and the risk of second knee injury after ACLR. The main objective of this study was to test if knee muscles strength symmetry at 4 months was associated with the psychological readiness and incidence of subsequent severe injury of both knees at a minimum 2 years follow-up after ACL-R.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Return-to-sport (RTS) follow-up

Study Design

Study Type:
Observational
Actual Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Association Between 4-Month Isokinetic Testing Measures and Second Knee Injuries After
Actual Study Start Date :
May 1, 2021
Actual Primary Completion Date :
May 1, 2021
Actual Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
ACLR patients with Return-to-sport (RTS) follow-up

All sports patients who had a muscle evaluation at 3-4 months after ACLR since January 2017

Diagnostic Test: Return-to-sport (RTS) follow-up
All sports patients who had a muscle evaluation at 3-4 months after ACLR since January 2017

Outcome Measures

Primary Outcome Measures

  1. Change in Strength [ACL group: Two evaluations on both injured and healthy knees: 3-4 months after surgery; Routine practice following guidelines]]

    Measurement of knee extensors and flexors peak strength (in newton.meter, Nm) on isokinetic dynamometer.

Secondary Outcome Measures

  1. Individual characteristics [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;]

    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 and severe reinjury on the operated knee or contralateral knee.

  2. Surgery characteristics [ACLR group: Two follow-up medical consultations 4 months after surgery]

    Surgery characteristics recorded in the medical report as the type of surgery, the surgery duration

  3. Re-injuries [ACLR group: One evaluation with a minimum 2 years follow-up after the surgery]

    Web based questionnaire about any sever knee injury (meniscus or ACL) after the primary ACLR

  4. Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) scale. [ACLR group: One evaluation with a minimum 2 years follow-up after the surgery]

    Web based questionnaire with completion of the Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) scale.

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 55 Years
Sexes Eligible for Study:
All
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 Patient who received the information form Patients with access to the Internet

Exclusion Criteria:

Patient who did not participate in all follow-up consultations and isokinetic muscular assessments Patients who had a previous knee surgery before the ACLR Cognitive or sensory impairment making it impossible to understand the information form Neurological, traumatic or osteoarticular history responsible for muscle imbalance prior to surgery

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Caen Normandie Caen France 14000

Sponsors and Collaborators

  • University Hospital, Caen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Joffrey DRIGNY, Senior Lecturer Practitioner, University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT05897970
Other Study ID Numbers:
  • PREDICT-ACLv2
First Posted:
Jun 12, 2023
Last Update Posted:
Jun 12, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 12, 2023