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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.

Tracking Information
First Submitted Date  ICMJE November 10, 2017
First Posted Date  ICMJE November 28, 2017
Last Update Posted Date November 30, 2017
Actual Study Start Date  ICMJE March 9, 2015
Actual Primary Completion Date February 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2017)
Pain improvement [ Time Frame: 90 days ]
Assessed using a 100-mm Visual Analog Scale (VAS)
Original Primary Outcome Measures  ICMJE
 (submitted: November 21, 2017)
  • Pain improvement [ Time Frame: 90 days ]
    Assessed using a 100-mm Visual Analog Scale (VAS)
  • Analgesic consumption [ Time Frame: 90 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2017)
  • 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
  • Analgesic consumption [ Time Frame: 90 days ]
    Analgesic consumption and frequency of analgesic intake during follow-up
  • Number of rehabilitation sessions required [ Time Frame: 90 days ]
    Number of required rehabilitation sessions at the end of follow-up.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2017)
  • 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
  • Number of rehabilitation sessions required [ Time Frame: 90 days ]
  • 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
Current Other Pre-specified Outcome Measures
 (submitted: November 28, 2017)
  • 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
  • Safety [ Time Frame: 90 days ]
    Assessed by means of all adverse events (AE) treatment related, reported at the end of follow-up.
Original Other Pre-specified Outcome Measures
 (submitted: November 21, 2017)
  • 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
  • Safety [ Time Frame: 90 days ]
    Treatment safety was assessed by means of all adverse events (AE) reported at the end of follow-up.
 
Descriptive Information
Brief Title  ICMJE Efficacy and Tolerability of a Nutritional Supplement, Plactive Progen, in ACL Reconstruction
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE ACL Reconstruction
Intervention  ICMJE Dietary Supplement: PROGEN
Dietary supplement based on plasma proteins, hydrolyzed collagen, a complex of Hyaluronic Acid - Chondroitin Sulfate (HC-15), and vitamin C
Study Arms  ICMJE
  • Active Comparator: PROGEN Group
    PROGEN + Standard Rehabilitation + ACL reconstruction
    Intervention: Dietary Supplement: PROGEN
  • No Intervention: Control Group
    Standard Rehabilitation + ACL reconstruction
Publications * López-Vidriero E, Olivé-Vilas R, López-Capapé D, Varela-Sende L, López-Vidriero R, Til-Pérez L. Efficacy and Tolerability of Progen, a Nutritional Supplement Based on Innovative Plasma Proteins, in ACL Reconstruction: A Multicenter Randomized Controlled Trial. Orthop J Sports Med. 2019 Feb 27;7(2):2325967119827237. doi: 10.1177/2325967119827237. eCollection 2019 Feb.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 21, 2017)
80
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 3, 2017
Actual Primary Completion Date February 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03355651
Other Study ID Numbers  ICMJE OPK-PLA-2015-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party OPKO Health, Inc.
Study Sponsor  ICMJE OPKO Health, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account OPKO Health, Inc.
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP