NCT03355651

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 9, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 28, 2017

Completed
Last Updated

November 30, 2017

Status Verified

November 1, 2017

Enrollment Period

1.9 years

First QC Date

November 10, 2017

Last Update Submit

November 28, 2017

Conditions

ACL Reconstruction

Keywords

Anterior Cruciate Ligament TearsDietary SupplementationsPlasma Rich ProteinsCollagenChondroitin SulfateHyaluronic Acid

Outcome Measures

Primary Outcomes (1)

  • Pain improvement

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

    90 days

Secondary Outcomes (4)

  • Knee function

    90 days

  • Analgesic consumption

    90 days

  • Number of rehabilitation sessions required

    90 days

  • Maduration of the graft

    Day 0, day 90

Other Outcomes (2)

  • Perceived efficacy and tolerability by both patients and physicians

    90 days

  • Safety

    90 days

Study Arms (2)

PROGEN Group

ACTIVE COMPARATOR

PROGEN + Standard Rehabilitation + ACL reconstruction

Dietary Supplement: PROGEN

Control Group

NO INTERVENTION

Standard Rehabilitation + ACL reconstruction

Interventions

PROGENDIETARY_SUPPLEMENT

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

PROGEN Group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lopez-Vidriero E, Olive-Vilas R, Lopez-Capape D, Varela-Sende L, Lopez-Vidriero R, Til-Perez 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.

    PMID: 30834280DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Estrogens, Conjugated (USP)

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Estradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
ACL parasagittal cuts were performed in T1 sequences and analyzed by a blinded musculoskeletal radiologist to improve the quality of the study
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2017

First Posted

November 28, 2017

Study Start

March 9, 2015

Primary Completion

February 1, 2017

Study Completion

March 3, 2017

Last Updated

November 30, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share