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Efficacy and Tolerability of a Nutritional Supplement, Plactive Progen, in ACL Reconstruction | Clinical Trials | Clareo Health

COMPLETEDNA

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

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

NCT03355651•OPKO Health, Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

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.

Key Dates

Start Date

March 9, 2015

Primary Completion Date

February 1, 2017

Completion Date

March 3, 2017

Last Updated

November 30, 2017

Enrollment

ACTUAL participants

Conditions

ACL Reconstruction

Interventions

PROGEN

DIETARY_SUPPLEMENT

Validity of the SHD-LESS Scale After ACL Reconstruction

NCT06829849

ACL ReconstructionACL Injury

View study

RECRUITINGNA

Does Blood Flow Restriction Training Improve Quadriceps Function After Arthroscopic Knee Surgery?

NCT03096366

Quadriceps AtrophyACL Reconstruction

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 30, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Validity of the SHD-LESS Scale After ACL Reconstruction

Does Blood Flow Restriction Training Improve Quadriceps Function After Arthroscopic Knee Surgery?

Developing and Validating the Risk-taking Intention and Sport Engagement After ACL Reconstruction (RISE-ACL) Scale

Clinical and Biomechanical Outcomes of Anterior Cruciate Ligament (ACL) Reconstruction Associated With Lateral Extra-articular Tenodesis (LET)

Test of Return to Sport After ACL Reconstruction and Cognitive Task.

Testosterone Administration and ACL Reconstruction in Men