NCT07249645

Brief Summary

ACL injuries are incapacitating for both professional and amateur athletes, with long-term repercussions on performance and return to sport (RTS). Surgical reconstruction of the ACL is the main treatment option. Despite this, recurrence rates are high. Half of all recurrences occur within 8 months of reconstruction, and 70% within the first 6 months after RTS. Decision to RTS is therefore an important one, as returning too early can increase the risk of recurrence, while returning too late delays a return to pre-injury performance levels. As described by the Bern Consensus, RTS consists of three phases :

  • Phase 1: Return to participation (RTp)
  • Phase 2: Return to sport (RTS)
  • Phase 3: Return to performance (RTP) RTS decision must be based on multiple factors, including psychological, athletic and functional components, as well as specific nature of the patient's activities. However, few individual tests have been associated with a specific level of RTS. Furthermore, the majority of studies rely on subjective and non-objective assessments to determine whether the athlete has returned to their pre-injury level. It would therefore be relevant to study the RTS time of patients who have performed a combination of several objective functional tests whose results could be complementary, in particular the K-STARTS, the CMJ, the DJ and the measurement of soleus muscle strength.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
24mo left

Started Dec 2025

Typical duration for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress18%
Dec 2025Apr 2028

First Submitted

Initial submission to the registry

November 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2028

Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

2.4 years

First QC Date

November 18, 2025

Last Update Submit

November 18, 2025

Conditions

Keywords

Return To Sport ACL injury

Outcome Measures

Primary Outcomes (1)

  • Return to sport

    This is time period (in months) between surgery and: * The date of return to sport (phase 2) for patients who resumed sport * The end of follow-up (timepoint date/date of death/date of loss of contact) for patients who did not resume sport

    18 months

Study Arms (1)

K-STARTS +

EXPERIMENTAL

K-STARTS + arm involves following tests : K-STARTS, CMJ, DJ and soleus muscle strength measurement

Other: Physical tests

Interventions

K-STARTS, CMJ, DJ, and soleus muscle strength measurement

K-STARTS +

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient, male or female, aged between ≥ 18 and ≤ 30 years old
  • Amateur athlete with a Tegner score ≥ 5
  • Patient with primary ACL reconstruction dating back 6 months
  • Patients with ACL damage in one knee only
  • Patients who have undergone an isokinetic strength test with results that do not contraindicate functional testing
  • Patients affiliated with or covered by a social security scheme
  • French-speaking patients who have signed an informed consent form

You may not qualify if:

  • Patients treated for bilateral ACL reconstruction
  • Patients who are professional athletes or compete at a national level
  • Patients with severe associated disorders (neurological, connective tissue, congenital diseases)
  • Patients with multiple ligament defects or associated osteotomy
  • Patients already included in another study
  • Protected patients: adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Central Study Contacts

Bertrand SONNERY-COTTET

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2025

First Posted

November 25, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

April 30, 2028

Last Updated

November 25, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share