ACL ReconstructionNCT03355651
Efficacy and Tolerability of a Nutritional Supplement, Plactive Progen, in ACL Reconstruction
A study testing PROGEN in people with ACL Reconstruction, run by OPKO Health, Inc..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- ACL Reconstruction
- What is being tested?
- PROGEN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 9 Mar 2015to 3 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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.
- Conditions
- ACL Reconstruction
- Being tested
- PROGEN
- Keywords
- Anterior Cruciate Ligament Tears, Dietary Supplementations, Plasma Rich Proteins, Collagen, Chondroitin Sulfate, Hyaluronic Acid
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROGENDietary supplement
Dietary supplement based on plasma proteins, hydrolyzed collagen, a complex of Hyaluronic Acid - Chondroitin Sulfate (HC-15), and vitamin C
| Study group | Role | What they receive |
|---|---|---|
| PROGEN Group | Active comparator | PROGEN + Standard Rehabilitation + ACL reconstruction Receives: Dietary Supplement: PROGEN |
| Control Group | No intervention | Standard Rehabilitation + ACL reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain improvement
Assessed using a 100-mm Visual Analog Scale (VAS)
Measured: 90 days
Secondary outcomes (4)
Knee function
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
Measured: 90 days
Analgesic consumption
Analgesic consumption and frequency of analgesic intake during follow-up
Measured: 90 days
Number of rehabilitation sessions required
Number of required rehabilitation sessions at the end of follow-up.
Measured: 90 days
Maduration of the graft
Assessed by MRI, by a single blind muskuloskeletal radiologist, using a standard procedure based on ACL oblique parasagittal T1 sequences
Measured: Day 0, day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start9 Mar 2015
- Primary completion1 Feb 2017
- Study completion3 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ACL ReconstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- OPKO Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355651
- Sponsor's protocol ID
- OPK-PLA-2015-01
- Status last verified
- Nov 2017
- First submitted
- 10 Nov 2017
- Last updated
- 30 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30834280
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03355651
- Acronym / sponsor ID
- OPK-PLA-2015-01
- Conditions
- ACL Reconstruction
- Keywords
- Anterior Cruciate Ligament Tears, Dietary Supplementations, Plasma Rich Proteins, Collagen, Chondroitin Sulfate, Hyaluronic Acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- OPKO Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Mar 2015 (actual)
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 3 Mar 2017 (actual)
- First posted
- 28 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PROGEN Group | Active comparator | Dietary Supplement: PROGENPROGEN + Standard Rehabilitation + ACL reconstruction |
| Control Group | No intervention | –Standard Rehabilitation + ACL reconstruction |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PROGENDietary supplement based on plasma proteins, hydrolyzed collagen, a complex of Hyaluronic Acid - Chondroitin Sulfate (HC-15), and vitamin C | Dietary supplement | PROGEN Group |
Primary outcome
Pain improvement
Time frame: 90 days
Assessed using a 100-mm Visual Analog Scale (VAS)
4 secondary outcomes
Knee function
Time frame: 90 days
Analgesic consumption
Time frame: 90 days
Number of rehabilitation sessions required
Time frame: 90 days
Maduration of the graft
Time frame: Day 0, day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- Derived from this study: PubMed 30834280Lopez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing PROGEN in people with ACL Reconstruction, run by OPKO Health, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain improvement (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03355651, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2017.