Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
NCT ID:
NCT06768957
Eligibility Criteria:
The inclusion criteria for the test group (patients with ACL reconstruction) were as follows :
* Patients with an isolated, unilateral ACL rupture, corresponding to a first injury occurring without contact,
* Patients who have undergone surgical reconstruction using an autograft of the semitendinosus tendon alone, or an autograft of the semitendinosus tendon and gracilis, or BTB surgery,
* Patients at 6 +/- 1 months post-operative management,
* Patients aged between 16 and 40 included,
* Patients whose level of physical activity, assessed using the Tegner scale, is greater than or equal to 5.
Patients meeting all these inclusion criteria will be included in the study.
Thus, for the test group, the non-inclusion criteria to be taken into account are as follows:
* Patients with injuries associated with ACL rupture,
* Patients who have received conservative treatment or who have benefited from another surgical technique,
* Patients less than 5 months or more than 7 months post-operatively,
* Patients aged under 16 or over 40,
* Patients with a Tegner score of less than 5,
* Patients with recurrent homolateral or controlateral ACL rupture,
* Patients with an ACL rupture resulting from a direct or indirect impact injury mechanism.
Finally, for the test group, the exclusion criteria to be taken into account are as follows:
* Refusal to take part in the study,
* Withdrawal of the participant during the study,
* Loss of sight of the participant between the two weeks.
For the control group (healthy persons), the inclusion criteria are similar to those for the test group. They correspond to :
* Persons with no knee trauma in the six months prior to the start of the study,
* Persons between 16 and 40 years of age included,
* Persons whose level of physical activity, assessed using the Tegner scale, was greater than or equal to 5.
Persons meeting all these inclusion criteria will be included in the study.
Thus, for the control group, the non-inclusion criteria are as follows:
* Persons with knee lesions in the six months preceding the start of the study,
* Persons aged under 16 or over 40,
* Persons with a Tegner score strictly below 5.
Finally, the exclusion criteria for this group correspond to :
* Refusal to take part in the study,
* Retraction of the participant during the study,
* Loss of vision between the two weeks,
* Knee trauma between the two weeks.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
40 Years
Study:
NCT06768957
Study Brief:
Protocol Section:
NCT06768957