Health TrialsbyHealthPanel

ACL Reconstruction: Clinical Outcome

ConditionACL Injury
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorStefano Zaffagnini

About this trial

The study is intended to include all patients who will undergo surgical reconstruction of the anterior cruciate ligament (ACL). The patients will be monitored and evaluated preoperatively and also at 6 months and 1, 2 and 5 years after the intervention through a clinical visit or telephone interview. Such assessments will include the administration of questionnaires to determine the patient's functional symptoms and the objective examination of the knee during a medical examination to quantify its stability.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who have provided informed written written consent;

Patients aged between 18 and 60;

Patients undergoing reconstructive surgical treatment of the anterior cruciate ligament (ACL)

Disqualifiers

Patients unable to understand and to want;

Patients who have not signed informed consent;

Trial population

Patients with ACL lesions and undergoing to surgical ACL reconstruction

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • ACL reconstruction

    Procedure/Surgery

    Surgical ACL reconstruction

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Knee Laxity Assessment

Laxity Evaluation with KiRA device

Time frame
5 years

Secondary outcomes

1

SF12 Score

The SF-12v2 is an abbreviated version of the SF-36. SF-36 is the best-known and most widely used measure of health-related quality of life in the international literature. It measures different health concepts through 36 multiple-choice questions, data are aggregated into 8 scales investigating: physical activity, role and physical health, physical pain, Health in general, vitality, social activities, role and emotional state, mental health, a question on change in health status during the last year is also added.

Time frame
5 years
2

Marx Activity Rating Score

The Marx Scale consists of four questions concerning four activities or actions: running, cutting, deceleration, and pivoting. The patient or survey respondent is asked to report on the frequency with which they performed the activity in their healthiest state within the past year.

Time frame
5 years
3

KOOS Score

KOOS SCORE consists of 5 subscales and covers: pain (9 items), symptoms (7 items, two of which are related to stiffness), functions and activities of daily living (17 items), physical function, sports and leisure activities (5 items) and quality of life in relation to the knee (4 items). Each question is scored from 0 to 4, where 0 indicates "no difficulty" and 4 "severe difficulty. Score range 0-100 for each subscale

Time frame
5 years
4

IKDC Score

This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathologies. All questions examines 3 categories: symptoms, sports activity, and knee function.

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stefano Zaffagnini

Lead sponsor

Istituto Ortopedico Rizzoli

Sponsor institution

Source ClinicalTrials.gov
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