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OpenTrials
Completed

NCT Number: NCT03355651

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

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.

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Key information

Conditions

ACL Reconstruction Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PROGEN

Dietary Supplement

Dietary supplement based on plasma proteins, hydrolyzed collagen, a complex of Hyaluronic Acid - Chondroitin Sulfate (HC-15), and vitamin C

Primary outcomes

  1. Pain improvement

    Time frame: 90 days

    Assessed using a 100-mm Visual Analog Scale (VAS)

Secondary outcomes

  1. Knee function

    Time frame: 90 days

    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

  2. Analgesic consumption

    Time frame: 90 days

    Analgesic consumption and frequency of analgesic intake during follow-up

  3. Number of rehabilitation sessions required

    Time frame: 90 days

    Number of required rehabilitation sessions at the end of follow-up.

  4. Maduration of the graft

    Time frame: Day 0, day 90

    Assessed by MRI, by a single blind muskuloskeletal radiologist, using a standard procedure based on ACL oblique parasagittal T1 sequences

Other outcomes

  1. Perceived efficacy and tolerability by both patients and physicians

    Time frame: 90 days

    Perceived efficacy and tolerability were rated by both patients and physicians on a 5-point Likert scale, where higher scores indicated better efficacy and tolerability

  2. Safety

    Time frame: 90 days

    Assessed by means of all adverse events (AE) treatment related, reported at the end of follow-up.

Sponsors and collaborators

Lead sponsor

OPKO Health, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 28, 2017
Registry last updated
Nov 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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