Rotator Cuff TearsNCT04703998
Arthroscopic Rotator Cuff Repair Augmented With Platelet Rich Plasma
A study testing Arthroscopic rotator cuff repair and platelet rich plasma in people with Rotator Cuff Tears, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
Purpose: To assess whether the use of platelet-rich plasma used as an adjuvant to arthroscopic rotator cuff repairs modify the rate of re-tears (measured by MRI) compared to a control group that only underwent the isolated arthroscopic repair. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Arthroscopic rotator cuff repair and platelet rich plasma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteArgentina
- Study dates
- 3 Jan 2021to 1 Sep 2022
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults between 50 and 75 years with a defined complete rotator cuff tear as compatible clinical and confirmation by magnetic resonance imaging (MRI).
- Minimum of 3 months of failed conservative treatment (anti-inflammatory, physical therapy and infiltration with corticosteroids)
Who cannot join
- Refusal to participate or informed consent,
- Revision surgery,
- Partial repair,
- Patients with shoulder osteoarthritis> 2
- Advanced fat infiltration of the rotator cuff muscles (STAGE 3 or 4)
- Systemic or rheumatoid arthritis,
Show all 13Show fewer
- Uncontrolled diabetes, (patients for whom surgery is contraindicated in the preoperative evaluation by the clinician and anesthesiologist)
- Acute or chronic infections of the shoulder to be operated on
- Ongoing cancer chemotherapy therapies
- Sepsis, septic arthritis, osteomyelitis or other ongoing infectious processes;
- Previous operations on the affected shoulder,
- Patients with autoimmune diseases;
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arthroscopic Rotator Cuff Repair Augmented With Platelet Rich Plasma. Prospective Randomized Controlled Trial.
Purpose: To assess whether the use of platelet-rich plasma used as an adjuvant to arthroscopic rotator cuff repairs modify the rate of re-tears (measured by MRI) compared to a control group that only underwent the isolated arthroscopic repair. Hypothesis: Platelet rich plasma used as an adjuvant to arthroscopic rotator cuff repairs decrease the rate of retears.
Read the detailed description
Platelet-rich plasma used as an adjuvant to arthroscopic rotator cuff repairs modify the rate of re-tears (measured by MRI) compared to a control group that only underwent the isolated arthroscopic repair.
- Conditions
- Rotator Cuff Tears
- Being tested
- Arthroscopic rotator cuff repair, platelet rich plasma
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic rotator cuff repairProcedure or surgery
A double-row rotator cuff repair will be performed.
platelet rich plasmaBiological
A single dose of 10 ml of autologous platelet rich plasma at the bone-tendon interfase will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic rotator cuff repair and platelet rich plasma | Experimental | A standard double-row arthroscopic rotator cuff repair will be performed and at the end of the procedure 10 ml of autologous platelet-rich plasma will be placed under direct vision at the tendon-bone interface. Receives: Procedure: Arthroscopic rotator cuff repair; Biological: platelet rich plasma |
| Arthroscopic rotator cuff repair | Active comparator | A standard double-row arthroscopic rotator cuff repair will be performed. Receives: Procedure: Arthroscopic rotator cuff repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of re-tear rates between groups.
Postoperative MRI to assess the structural integrity of the repaired rotator cuff.
Measured: 6 months
Secondary outcomes (3)
Change From baseline in shoulder functional scores at 3, 6 and 12 months
The ASES score (American Shoulder and Elbow Surgeons) and the Constant score will be used. Both scores assess the general function of the shoulder in different activities of daily life, global mobility of the shoulder and pain with usual tasks. They are scores ranging from 0 to 100. Both scores are validated and are the reference scores for clinical research on rotator cuff pathology
Measured: baseline, 3, 6, and 12 months
Change From baseline in pain at 3, 6 and 12 months
The visual analog scale (VAS) will be used to assess the level of pain during activities of daily living. 0 will be considered as "no pain" and 10 as "the worst pain of his life."
Measured: baseline, 3, 6, and 12 months
Number of Participants With Treatment-Related Adverse Events
Adverse effects and postoperative complications will be recorded.
Measured: 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start3 Jan 2021
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
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 Rotator Cuff TearsStudies 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
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LUCIANO ANDRES ROSSI, Hospital Italiano de Buenos Aires
- Investigators
- Luciano Rossi, MD, Principal investigator, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703998
- Sponsor's protocol ID
- 5702
- Status last verified
- Dec 2022
- First submitted
- 3 Jan 2021
- Last updated
- 22 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We are planning on sharing the study protocol and the tables contaning all outcomes for every individual patient
Publications
Rossi LA, Gorodischer TD, Camino P, Brandariz RN, Tanoira I, Piuzzi NS, Ranalletta M. Leukocyte-Poor Platelet-Rich Plasma as an Adjuvant to Arthroscopic Rotator Cuff Repair Reduces the Retear Rate But Does Not Improve Functional Outcomes: A Double-Blind Randomized Controlled Trial. Am J Sports Med. 2024 May;52(6):1403-1410. doi: 10.1177/03635465241239062. Epub 2024 Apr 8.
PubMed 38587033
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Rotator Cuff Repair Augmented With Platelet Rich Plasma. Prospective Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04703998
- Acronym / sponsor ID
- 5702
- Conditions
- Rotator Cuff Tears
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- 3 Jan 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 11 Jan 2021 (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.
Purpose: To assess whether the use of platelet-rich plasma used as an adjuvant to arthroscopic rotator cuff repairs modify the rate of re-tears (measured by MRI) compared to a control group that only underwent the isolated arthroscopic repair. Hypothesis: Platelet rich plasma used as an adjuvant to arthroscopic rotator cuff repairs decrease the rate of retears.
Detailed description
Platelet-rich plasma used as an adjuvant to arthroscopic rotator cuff repairs modify the rate of re-tears (measured by MRI) compared to a control group that only underwent the isolated arthroscopic repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic rotator cuff repair and platelet rich plasma | Experimental | Procedure: Arthroscopic rotator cuff repair, Biological: platelet rich plasmaA standard double-row arthroscopic rotator cuff repair will be performed and at the end of the procedure 10 ml of autologous platelet-rich plasma will be placed under direct vision at the tendon-bone interface. |
| Arthroscopic rotator cuff repair | Active comparator | Procedure: Arthroscopic rotator cuff repairA standard double-row arthroscopic rotator cuff repair will be performed. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults between 50 and 75 years with a defined complete rotator cuff tear as compatible clinical and confirmation by magnetic resonance imaging (MRI).
- Minimum of 3 months of failed conservative treatment (anti-inflammatory, physical therapy and infiltration with corticosteroids)
Key exclusion criteria (13 listed)
- Refusal to participate or informed consent,
- Revision surgery,
- Partial repair,
- Patients with shoulder osteoarthritis> 2
- Advanced fat infiltration of the rotator cuff muscles (STAGE 3 or 4)
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 rotator cuff repairA double-row rotator cuff repair will be performed. | Procedure or surgery | Arthroscopic rotator cuff repair, Arthroscopic rotator cuff repair and platelet rich plasma |
| platelet rich plasmaA single dose of 10 ml of autologous platelet rich plasma at the bone-tendon interfase will be administered. | Biological | Arthroscopic rotator cuff repair and platelet rich plasma |
Primary outcome
Comparison of re-tear rates between groups.
Time frame: 6 months
Postoperative MRI to assess the structural integrity of the repaired rotator cuff.
3 secondary outcomes
Change From baseline in shoulder functional scores at 3, 6 and 12 months
Time frame: baseline, 3, 6, and 12 months
Change From baseline in pain at 3, 6 and 12 months
Time frame: baseline, 3, 6, and 12 months
Number of Participants With Treatment-Related Adverse Events
Time frame: 3, 6, and 12 months
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 22 Dec 2022.
- Derived from this study: PubMed 38587033Rossi LA, Gorodischer TD, Camino P, Brandariz RN, Tanoira I, Piuzzi NS, Ranalletta M. Leukocyte-Poor Platelet-Rich Plasma as an Adjuvant to Arthroscopic Rotator Cuff Repair Reduces the Retear Rate But Does Not Improve Functional Outcomes: A Double-Blind Randomized Controlled Trial. Am J Sports Med. 2024 May;52(6):1403-1410. doi: 10.1177/03635465241239062. Epub 2024 Apr 8.
- Individual participant dataSharing planned: Yes. We are planning on sharing the study protocol and the tables contaning all outcomes for every individual patient
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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.
Luciano Rossi, MD principal investigator
Hospital Italiano de Buenos Aires
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic rotator cuff repair and platelet rich plasma in people with Rotator Cuff Tears, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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 2 inclusion and 13 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 22 Dec 2022. 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 Argentina. 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.
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?
Comparison of re-tear rates between groups. (time frame: 6 months). 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 NCT04703998, 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 22 Dec 2022.