- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07249645
Description of Return to Sport in Amateur Athletes Who Underwent Several Functional Tests (K-STARTS, Vertical Jumps and Soleus Muscle Strength) After Initial ACL Reconstruction (K-STARTS +)
Description of Return to Sport in Amateur Athletes Who Underwent Several Functional Tests (K-STARTS, Vertical Jumps and Soleus Muscle Strength) After Initial ACL Reconstruction.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
ACL injuries are incapacitating for both professional and amateur athletes, with long-term repercussions on performance and return to sport (RTS). Only 60% of amateurs return to their pre-injury level of performance.
Surgical reconstruction of the ACL is the main treatment option. Despite this, recurrence rates are high (ranging from 17% to 40% depending on the population). Half of all recurrences occur within 8 months of reconstruction, and 70% within the first 6 months after RTS. The 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 (Ardern et al. 2016):
- 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 :
- The Knee Santy Athletic Return to Sport (K-STARTS) test, which includes psychological and functional assessments of the knee. The K-STARTS test consists mainly of horizontal jumps that assess the functional capabilities of the knee.
- A. Kotsifaki, et al. (2021) assessed the contribution of the knee joint during various horizontal and vertical jumping tasks. In particular, they reported a greater contribution of the knee during propulsion in vertical vs. horizontal jumps (34.1% vs. 12.9%, respectively) and, conversely, a greater contribution of the knee during landing in horizontal vs. vertical jumps (64.7% vs. 34.3%, respectively). Thus, the combination of vertical and horizontal jumps would allow for a functional assessment of the knee during the different phases of jumping. Counter-Movement Jump (CMJ) and drop jump (DJ) are the main types of vertical jumps recommended for functional assessment of the knee.
- Measurement of soleus muscle strength. Recent studies have shown a decrease in the contribution of the soleus muscle during propulsion and landing in horizontal and vertical jumps in subjects with ACL injury.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bertrand SONNERY-COTTET
- Phone Number: +33437530022
- Email: sonnerycottet@aol.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: K-STARTS +
K-STARTS + arm involves following tests : K-STARTS, CMJ, DJ and soleus muscle strength measurement
|
K-STARTS, CMJ, DJ, and soleus muscle strength measurement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Return to sport
Time Frame: 18 months
|
This is time period (in months) between surgery and:
|
18 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-A01104-45
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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