Rotator Cuff Tears of the ShoulderPhase 2PRP-FibrinNCT01612845
Effect of Platelet-rich Fibrin on Rotator Cuff Repair
A Phase 2 study testing Arthroscopic repair without platelet rich fibrin and PRF (vivostat ®) administration after rotator cuff repair in people with Rotator Cuff Tears of the Shoulder, run by Hospital Universitario La Paz at 1 site in Spain.
Trial summary
The objective of this study was to prospectively evaluate the influence of local application of Platelet Rich Fibrin (PRF) on the functional outcome and integrity of the arthroscopically repaired tendons in patients with massive tears of the rotator cuff. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rotator Cuff Tears of the Shoulder
- What is being tested?
- Arthroscopic repair without platelet rich fibrin and PRF (vivostat ®) administration after rotator cuff repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSpain
- Study dates
- May 2007to Jun 2011
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Massive rotator cuff tears affecting supraspinatus and infraspinatus
- Failed conservative treatment for at least 6 months
- No hematologic disorder
Who cannot join
- Rotator cuff affecting subscapularis
- chronic infectious disease
- anemia
- clot disorders
- low platelet count
- history of difficulty in venous puncture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Platelet-Rich Fibrin for Arthroscopically Repaired Massive Rotator Cuff Tears: A Prospective Randomized Pilot Clinical Trial
The objective of this study was to prospectively evaluate the influence of local application of Platelet Rich Fibrin (PRF) on the functional outcome and integrity of the arthroscopically repaired tendons in patients with massive tears of the rotator cuff.
Read the detailed description
A prospective, randomized clinical trial was performed on 28 patients (22 females, 6 males) with an average age of 65 years (range, 53 to 77) undergoing complete arthroscopic repair of a massive rotator cuff tear. In 14 patients, after the repair was completed, 6 cc. of PRF (vivostat ®) were locally applied to the repair site. In 14 patients no addition of PRF was performed. All patients underwent an arthro-MRI to evaluate the integrity of the repair and a clinical exam one year after the operation. All patients were then followed clinically at a minimum of 2 years. Functional outcome was evaluated with the Constant and DASH scores.
- Conditions
- Rotator Cuff Tears of the Shoulder
- Being tested
- Arthroscopic repair without platelet rich fibrin, PRF (vivostat ®) administration after rotator cuff repair
- Keywords
- rotator cuff, shoulder, platelet rich plasma, fibrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic repair without platelet rich fibrinProcedure or surgery
after the tendon is repaired, no additional procedures are performed and no PRF is administered
PRF (vivostat ®) administration after rotator cuff repairBiological
7cc. of autologous PRF are locally administered to the repair site after reconstruction of the rotator cuff
| Study group | Role | What they receive |
|---|---|---|
| PRF | Experimental | the group in which the PRF was administered Receives: Biological: PRF (vivostat ®) administration after rotator cuff repair |
| Control | Active comparator | repair without PRF Receives: Procedure: Arthroscopic repair without platelet rich fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
rotator cuff tear healing rate after surgical reconstruction evaluated by arthro-MRI
Measured: one year
Secondary outcomes (2)
functional outcome evaluated with constant score
Measured: two years
disability outcome evaluated with dash score
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2012 (estimated)
- Study startMay 2007
- Primary completionMay 2009
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff Tears of the ShoulderStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- spanish society of orthopedics and traumatology
- Responsible party
- Principal investigator, Samuel Antuna, Hospital Universitario La Paz
- Investigators
- Samuel A Antuña, MD PhD, Study director, H. La PAzRaul Barco, MD PhD, Principal investigator, HU La PAzJose M Martinez, MD, Principal investigator, HU La PazJose M sanchez, MD, Principal investigator, HU La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612845
- Sponsor's protocol ID
- PI-523
- Acronym
- PRP-Fibrin
- Status last verified
- Jun 2012
- First submitted
- 4 Jun 2012
- Last updated
- 6 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Jo CH, Kim JE, Yoon KS, Lee JH, Kang SB, Lee JH, Han HS, Rhee SH, Shin S. Does platelet-rich plasma accelerate recovery after rotator cuff repair? A prospective cohort study. Am J Sports Med. 2011 Oct;39(10):2082-90. doi: 10.1177/0363546511413454. Epub 2011 Jul 7.
PubMed 21737832Randelli P, Arrigoni P, Ragone V, Aliprandi A, Cabitza P. Platelet rich plasma in arthroscopic rotator cuff repair: a prospective RCT study, 2-year follow-up. J Shoulder Elbow Surg. 2011 Jun;20(4):518-28. doi: 10.1016/j.jse.2011.02.008.
PubMed 21570659Castricini R, Longo UG, De Benedetto M, Panfoli N, Pirani P, Zini R, Maffulli N, Denaro V. Platelet-rich plasma augmentation for arthroscopic rotator cuff repair: a randomized controlled trial. Am J Sports Med. 2011 Feb;39(2):258-65. doi: 10.1177/0363546510390780. Epub 2010 Dec 15.
PubMed 21160018Barber FA, Hrnack SA, Snyder SJ, Hapa O. Rotator cuff repair healing influenced by platelet-rich plasma construct augmentation. Arthroscopy. 2011 Aug;27(8):1029-35. doi: 10.1016/j.arthro.2011.06.010.
PubMed 21802625
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet-Rich Fibrin for Arthroscopically Repaired Massive Rotator Cuff Tears: A Prospective Randomized Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT01612845
- Acronym / sponsor ID
- PRP-Fibrin / PI-523
- Conditions
- Rotator Cuff Tears of the Shoulder
- Keywords
- rotator cuff, shoulder, platelet rich plasma, fibrin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- spanish society of orthopedics and traumatology
- Study start
- May 2007
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 6 Jun 2012 (estimated)
- 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.
The objective of this study was to prospectively evaluate the influence of local application of Platelet Rich Fibrin (PRF) on the functional outcome and integrity of the arthroscopically repaired tendons in patients with massive tears of the rotator cuff.
Detailed description
A prospective, randomized clinical trial was performed on 28 patients (22 females, 6 males) with an average age of 65 years (range, 53 to 77) undergoing complete arthroscopic repair of a massive rotator cuff tear. In 14 patients, after the repair was completed, 6 cc. of PRF (vivostat ®) were locally applied to the repair site. In 14 patients no addition of PRF was performed. All patients underwent an arthro-MRI to evaluate the integrity of the repair and a clinical exam one year after the operation. All patients were then followed clinically at a minimum of 2 years. Functional outcome was evaluated with the Constant and DASH scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRF | Experimental | Biological: PRF (vivostat ®) administration after rotator cuff repairthe group in which the PRF was administered |
| Control | Active comparator | Procedure: Arthroscopic repair without platelet rich fibrinrepair without PRF |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Massive rotator cuff tears affecting supraspinatus and infraspinatus
- Failed conservative treatment for at least 6 months
- No hematologic disorder
Key exclusion criteria (6 listed)
- Rotator cuff affecting subscapularis
- chronic infectious disease
- anemia
- clot disorders
- low platelet count
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 |
|---|---|---|
| Arthroscopic repair without platelet rich fibrinafter the tendon is repaired, no additional procedures are performed and no PRF is administered | Procedure or surgery | Control |
| PRF (vivostat ®) administration after rotator cuff repair7cc. of autologous PRF are locally administered to the repair site after reconstruction of the rotator cuff | Biological | PRF |
Primary outcome
rotator cuff tear healing rate after surgical reconstruction evaluated by arthro-MRI
Time frame: one year
2 secondary outcomes
functional outcome evaluated with constant score
Time frame: two years
disability outcome evaluated with dash score
Time frame: two years
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 6 Jun 2012.
- Background: PubMed 21737832Jo CH, Kim JE, Yoon KS, Lee JH, Kang SB, Lee JH, Han HS, Rhee SH, Shin S. Does platelet-rich plasma accelerate recovery after rotator cuff repair? A prospective cohort study. Am J Sports Med. 2011 Oct;39(10):2082-90. doi: 10.1177/0363546511413454. Epub 2011 Jul 7.
- Background: PubMed 21570659Randelli P, Arrigoni P, Ragone V, Aliprandi A, Cabitza P. Platelet rich plasma in arthroscopic rotator cuff repair: a prospective RCT study, 2-year follow-up. J Shoulder Elbow Surg. 2011 Jun;20(4):518-28. doi: 10.1016/j.jse.2011.02.008.
- Background: PubMed 21160018Castricini R, Longo UG, De Benedetto M, Panfoli N, Pirani P, Zini R, Maffulli N, Denaro V. Platelet-rich plasma augmentation for arthroscopic rotator cuff repair: a randomized controlled trial. Am J Sports Med. 2011 Feb;39(2):258-65. doi: 10.1177/0363546510390780. Epub 2010 Dec 15.
- Results publication: PubMed 21802625Barber FA, Hrnack SA, Snyder SJ, Hapa O. Rotator cuff repair healing influenced by platelet-rich plasma construct augmentation. Arthroscopy. 2011 Aug;27(8):1029-35. doi: 10.1016/j.arthro.2011.06.010.
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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.
Samuel A Antuña, MD PhD study director
H. La PAz
Raul Barco, MD PhD principal investigator
HU La PAz
Jose M Martinez, MD principal investigator
HU La Paz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Arthroscopic repair without platelet rich fibrin and PRF (vivostat ®) administration after rotator cuff repair in people with Rotator Cuff Tears of the Shoulder, run by Hospital Universitario La Paz at 1 site in Spain.
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 3 inclusion and 6 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 6 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
rotator cuff tear healing rate after surgical reconstruction evaluated by arthro-MRI (time frame: one year). 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 NCT01612845, which also lists 4 linked publications.
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 6 Jun 2012.