Efficacy and Tolerability of a Nutritional Supplement, Plactive Progen, in ACL Reconstruction

Study Overview
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Brief Summary
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This was a prospective, multicenter, randomized, open-label, phase IV trial to compare the efficacy of supplementation with plasma proteins, hydrolyzed collagen (CH), a complex of HA-CS (HC-15), and vitamin C combined with a standard rehabilitation protocol versus the standard rehabilitation protocol only after arthroscopically-assisted functional ACL reconstruction with hamstrings.

Official Title
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Prospective Study for Assess Efficacy and Tolerability of an Oral Supplement Based on Collagen, HC-15 and Plasmatic Proteins, in the Recovery of ACL After Surgery: a Multicenter, Randomized, Controlled Trial

Conditions
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ACL Reconstruction

Intervention / Treatment
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* Dietary Supplement: PROGEN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects aged between 18 and 55 years with partial or complete anterior cruciate ligament (ACL) rupture, diagnosed clinically and by Magnetic Resonance Imaging (MRI), requiring reconstructive surgery. Patients with symptoms of acute or subacute ACL rupture (such as inflammation of the knee and pain with leg movement) or chronic ACL tear, including instability of the knee. Patients with ACL ruptures without osteochondral lesions requiring additional surgery. Patients with a medical history of therapeutic benefit using analgesic agents. Exclusion Criteria: Patients with concomitant osteochondral pathology. Patients treated with intra-articular injections of corticosteroids and/or platelet-rich plasma, or with oral glucosamine, CS, HA or CH in the two months prior to surgery. Patients with systemic diseases, those treated with antibiotics or other drugs that might alter the healing process, and those who had undergone arthroscopic lavage in the 90 days prior to surgery.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PROGEN Group<br>PROGEN + Standard Rehabilitation + ACL reconstruction | Dietary Supplement: PROGEN<br>* Dietary supplement based on plasma proteins, hydrolyzed collagen, a complex of Hyaluronic Acid - Chondroitin Sulfate (HC-15), and vitamin C<br>|
| No Intervention: Control Group<br>Standard Rehabilitation + ACL reconstruction | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain improvement | Assessed using a 100-mm Visual Analog Scale (VAS) | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee function | Assessed using the International Knee Documentation Committee (IKDC) index. The final score was interpreted as a measure of function, with higher scores representing higher levels of function | 90 days | 
| Analgesic consumption | Analgesic consumption and frequency of analgesic intake during follow-up | 90 days | 
| Number of rehabilitation sessions required | Number of required rehabilitation sessions at the end of follow-up. | 90 days | 
| Maduration of the graft | Assessed by MRI, by a single blind muskuloskeletal radiologist, using a standard procedure based on ACL oblique parasagittal T1 sequences | Day 0, day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anterior Cruciate Ligament Tears, Dietary Supplementations, Plasma Rich Proteins, Collagen, Chondroitin Sulfate, Hyaluronic Acid