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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03355651
Recruitment Status : Completed
First Posted : November 28, 2017
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
OPKO Health, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
ACL Reconstruction Dietary Supplement: PROGEN Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: ACL parasagittal cuts were performed in T1 sequences and analyzed by a blinded musculoskeletal radiologist to improve the quality of the study
Primary Purpose: Treatment
Official 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
Actual Study Start Date : March 9, 2015
Actual Primary Completion Date : February 1, 2017
Actual Study Completion Date : March 3, 2017

Resource links provided by the National Library of Medicine


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


Outcome Measures
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Primary Outcome Measures :
  1. Pain improvement [ Time Frame: 90 days ]
    Assessed using a 100-mm Visual Analog Scale (VAS)


Secondary Outcome Measures :
  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 Outcome Measures:
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: OPKO Health, Inc.
ClinicalTrials.gov Identifier: NCT03355651    
Other Study ID Numbers: OPK-PLA-2015-01
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by OPKO Health, Inc.:
Anterior Cruciate Ligament Tears
Dietary Supplementations
Plasma Rich Proteins
 Collagen
Chondroitin Sulfate
Hyaluronic Acid