Rotator Cuff TearNCT01788683
Regenexx™ SD Versus Exercise Therapy for Rotator Cuff Tears
A study testing Regenexx SD and Exercise Therapy in people with Rotator Cuff Tear, run by Regenexx, LLC at 1 site in United States.
Trial summary
The primary objective of this study is to compare the improvement in subject-reported clinical outcomes, for Regenexx SD treatment vs. Exercise Therapy of non-retracted supraspinatus tendon tears, from baseline to 3 months, with continued evaluation of efficacy and durability up to 24 months. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Regenexx SD and Exercise Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to 28 Jul 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physical examination consistent with Rotator Cuff tear
- Unremitting pain in the affected shoulder for at least 3 months
- Significant functional disability related to pain, lack of strength, or other shoulder symptoms
- Positive diagnostic imaging, which may include arthrogram, ultrasound and/or MR, on the affected shoulder indicating a non-retracted supraspinatus tendon tear comprising at least one half the tendon thickness in the anterior-posterior and/or superior-inferior planes
- Reasonable movement of the non-treated arm, defined as a shoulder elevation of equal or more than 90°, and able to perform (post-injection) exercises
- Is independent, ambulatory, and can comply with all post-operative evaluations and visits
Who cannot join
- A massive rotator cuff tear as demonstrated by Grade 3 or less muscle strength on testing internal and external rotation of the affected shoulder
- Previous surgery to the affected shoulder
- Concomitant tears of biceps tendons
- Grade 2 or greater SLAP tear
- Type 3 acromion
- Significant bone spur in subacromial space
Show all 21Show fewer
- Inflammatory or auto-immune based joint diseases or other upper extremity pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout pseudogout)
- Quinolone or Statin induced myopathy/ tendinopathy
- Kellgren-Lawrence grade 2 or greater glenohumeral osteoarthritis
- Adhesive capsulitis (mild or severe)
- Symptomatic cervical spine pathology (e.g. radicular cervical pain)
- Severe neurogenic inflammation of the cutaneous nerves about the shoulder
- Shoulder instability requiring surgical stabilization
- Contraindications for MRI
- Tested positive or has been treated for a malignancy in the past or is suspected of having a malignancy or is currently undergoing radiation or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed injection site
- Condition represents a worker's compensation case
- Currently involved in a health-related litigation procedure
- Is pregnant
- Bleeding disorders
- Currently taking anticoagulant or immunosuppressive medication
- Use of chronic opioid
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Regenexx™ SD Versus Exercise Therapy for Treatment of Non-retracted Supraspinatus Tendon Tears
The primary objective of this study is to compare the improvement in subject-reported clinical outcomes, for Regenexx SD treatment vs. Exercise Therapy of non-retracted supraspinatus tendon tears, from baseline to 3 months, with continued evaluation of efficacy and durability up to 24 months.
Secondary objectives include evaluation of US evidence of tendon repair; incidence of post-operative complications, adverse events, re-injections, and surgical intervention; change in pain score and use of pain medications.
Read the detailed description
Prospective, randomized, controlled to include 34 subjects treated with Regenexx SD and 17 subjects treated with Exercise Therapy alone (2:1 randomization).
Subjects will have a non-retracted supraspinatus tendon tear comprising at least one half the tendon thickness in the anterior-posterior and/or superior-inferior planes as evidenced with positive diagnostic imaging such as arthrogram, ultrasound and/or MR.
Subjects will be enrolled within 60 days prior to Regenexx-SD injection or initiation of exercise therapy and take part in follow-up visits for two years following treatment. A preoperative visit will occur at the time of enrollment; follow-up visits will occur at the clinical site at 6 weeks, 3 months, 6 months, 12 months, and 24 months post injection.
The primary endpoint analysis will be conducted once all subjects reach the 3 month endpoint. At that point, subjects enrolled in the Exercise Therapy group will be given the option of crossing over to the Regenexx SD treatment groups. Subjects will continue to be followed through the 2 year endpoint with data analysis performed at the 1 year and 2 year time points.
Subjects will complete the study following the 2 year follow-up visit.
- Conditions
- Rotator Cuff Tear
- Being tested
- Regenexx SD, Exercise Therapy
- Keywords
- Rotator Cuff, Rotator Cuff Tear, Supraspinatus Tear
- 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.
Regenexx SDProcedure or surgery
stem cell treatment
Exercise TherapyOther
exercise therapy control
| Study group | Role | What they receive |
|---|---|---|
| Regenexx SD | Active comparator | Bone Marrow Aspirate Concentrate injected under imaging guidance into the area of the damaged tendon. Receives: Procedure: Regenexx SD |
| Exercise Therapy | Active comparator | Subjects will be instructed in a set of appropriate rotator cuff strengthening exercises and given an instructional hand-out to take home. Receives: Other: Exercise Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
DASH Score Change from Baseline
The primary endpoint for this study is the difference between treatment groups in the within patient mean change from baseline to 3 months in Disabilities of the Arm Shoulder and Hand (DASH) scores.
Measured: Change from Baseline to 3 months
Secondary outcomes (5)
Mean Pain Scales
Difference between treatment groups in mean 0-10 pain scales at each follow-up timepoint
Measured: 3, 6, 12 and 24 months
MRI evidence of tendon repair
Comparison between groups of MRI evidence of tendon repair at 12 months
Measured: 12 months
Mean DASH scores
Difference between treatment groups in mean Disabilities of Arm Shoulder and Hand (DASH) scores at 6, 12 and 24 months.
Measured: 6, 12 and 24 months
Incidence of Complications and Adverse Events
Incidence and time to resolution of post-operative complications and adverse events between treatment groups.
Measured: 24 months
Incidence of re-injection and surgical revision
Incidence of and time to re-injection and surgical revision between treatment groups.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completion28 Aug 2020
- Study completion28 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regenexx, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Centeno, MD, Principal investigator, Centeno-Schultz Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788683
- Sponsor's protocol ID
- RSI2012-RCT01
- Status last verified
- Dec 2022
- First submitted
- 6 Feb 2013
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Centeno CJ, Fausel Z, Dodson E, Berger DR, Steinmetz NJ. Percutaneous bone marrow concentrate and platelet products versus exercise therapy for the treatment of rotator cuff tears: a randomized controlled, crossover trial with 2-year follow-up. BMC Musculoskelet Disord. 2024 May 18;25(1):392. doi: 10.1186/s12891-024-07519-6.
PubMed 38762734Centeno C, Fausel Z, Stemper I, Azuike U, Dodson E. A Randomized Controlled Trial of the Treatment of Rotator Cuff Tears with Bone Marrow Concentrate and Platelet Products Compared to Exercise Therapy: A Midterm Analysis. Stem Cells Int. 2020 Jan 30;2020:5962354. doi: 10.1155/2020/5962354. eCollection 2020.
PubMed 32399045
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Regenexx™ SD Versus Exercise Therapy for Treatment of Non-retracted Supraspinatus Tendon Tears
- ClinicalTrials.gov ID
- NCT01788683
- Acronym / sponsor ID
- RSI2012-RCT01
- Conditions
- Rotator Cuff Tear
- Keywords
- Rotator Cuff, Rotator Cuff Tear, Supraspinatus Tear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Regenexx, LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2013 (actual)
- Primary completion
- 28 Aug 2020 (actual)
- Study completion
- 28 Jul 2022 (actual)
- First posted
- 11 Feb 2013 (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 primary objective of this study is to compare the improvement in subject-reported clinical outcomes, for Regenexx SD treatment vs. Exercise Therapy of non-retracted supraspinatus tendon tears, from baseline to 3 months, with continued evaluation of efficacy and durability up to 24 months.
Secondary objectives include evaluation of US evidence of tendon repair; incidence of post-operative complications, adverse events, re-injections, and surgical intervention; change in pain score and use of pain medications.
Detailed description
Prospective, randomized, controlled to include 34 subjects treated with Regenexx SD and 17 subjects treated with Exercise Therapy alone (2:1 randomization).
Subjects will have a non-retracted supraspinatus tendon tear comprising at least one half the tendon thickness in the anterior-posterior and/or superior-inferior planes as evidenced with positive diagnostic imaging such as arthrogram, ultrasound and/or MR.
Subjects will be enrolled within 60 days prior to Regenexx-SD injection or initiation of exercise therapy and take part in follow-up visits for two years following treatment. A preoperative visit will occur at the time of enrollment; follow-up visits will occur at the clinical site at 6 weeks, 3 months, 6 months, 12 months, and 24 months post injection.
The primary endpoint analysis will be conducted once all subjects reach the 3 month endpoint. At that point, subjects enrolled in the Exercise Therapy group will be given the option of crossing over to the Regenexx SD treatment groups. Subjects will continue to be followed through the 2 year endpoint with data analysis performed at the 1 year and 2 year time points.
Subjects will complete the study following the 2 year follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regenexx SD | Active comparator | Procedure: Regenexx SDBone Marrow Aspirate Concentrate injected under imaging guidance into the area of the damaged tendon. |
| Exercise Therapy | Active comparator | Other: Exercise TherapySubjects will be instructed in a set of appropriate rotator cuff strengthening exercises and given an instructional hand-out to take home. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Physical examination consistent with Rotator Cuff tear
- Unremitting pain in the affected shoulder for at least 3 months
- Significant functional disability related to pain, lack of strength, or other shoulder symptoms
- Positive diagnostic imaging, which may include arthrogram, ultrasound and/or MR, on the affected shoulder indicating a non-retracted supraspinatus tendon tear comprising at least one half the tendon thickness in the anterior-posterior and/or superior-inferior planes
- Reasonable movement of the non-treated arm, defined as a shoulder elevation of equal or more than 90°, and able to perform (post-injection) exercises
Key exclusion criteria (21 listed)
- A massive rotator cuff tear as demonstrated by Grade 3 or less muscle strength on testing internal and external rotation of the affected shoulder
- Previous surgery to the affected shoulder
- Concomitant tears of biceps tendons
- Grade 2 or greater SLAP tear
- Type 3 acromion
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 |
|---|---|---|
| Regenexx SDstem cell treatment | Procedure or surgery | Regenexx SD |
| Exercise Therapyexercise therapy control | Other | Exercise Therapy |
Primary outcome
DASH Score Change from Baseline
Time frame: Change from Baseline to 3 months
The primary endpoint for this study is the difference between treatment groups in the within patient mean change from baseline to 3 months in Disabilities of the Arm Shoulder and Hand (DASH) scores.
5 secondary outcomes
Mean Pain Scales
Time frame: 3, 6, 12 and 24 months
MRI evidence of tendon repair
Time frame: 12 months
Mean DASH scores
Time frame: 6, 12 and 24 months
Incidence of Complications and Adverse Events
Time frame: 24 months
Incidence of re-injection and surgical revision
Time frame: 24 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 21 Dec 2022.
- Derived from this study: PubMed 38762734Centeno CJ, Fausel Z, Dodson E, Berger DR, Steinmetz NJ. Percutaneous bone marrow concentrate and platelet products versus exercise therapy for the treatment of rotator cuff tears: a randomized controlled, crossover trial with 2-year follow-up. BMC Musculoskelet Disord. 2024 May 18;25(1):392. doi: 10.1186/s12891-024-07519-6.
- Derived from this study: PubMed 32399045Centeno C, Fausel Z, Stemper I, Azuike U, Dodson E. A Randomized Controlled Trial of the Treatment of Rotator Cuff Tears with Bone Marrow Concentrate and Platelet Products Compared to Exercise Therapy: A Midterm Analysis. Stem Cells Int. 2020 Jan 30;2020:5962354. doi: 10.1155/2020/5962354. eCollection 2020.
- 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.
Christopher Centeno, MD principal investigator
Centeno-Schultz Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regenexx SD and Exercise Therapy in people with Rotator Cuff Tear, run by Regenexx, LLC at 1 site in United States.
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 6 inclusion and 21 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 21 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 United States. 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?
DASH Score Change from Baseline (time frame: Change from Baseline to 3 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 NCT01788683, which also lists 2 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 21 Dec 2022.