Rotator Cuff TearsNCT05106088
Variation in Humeral Head Bone Marrow Characteristics With Rotator Cuff Repair Healing
An observational study of Rotator Cuff Tears and Rotator Cuff Repairs, run by The Cleveland Clinic at 1 site in United States.
Trial summary
This study investigates correlations between humeral head bone marrow characteristics and tendon healing of rotator cuff repairs. The anticipated results would motivate future research aimed to investigate local enrichment or transplantation of connective tissue progenitor cells to augment rotator cuff repair and the… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tears, Rotator Cuff Repairs
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2021to 30 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Males or females, 18-75 years, with a 1-5 cm full thickness tear of the supraspinatus and/or infraspinatus tendon(s) requiring surgical repair
Who may be able to join
- Males or females
- 18-75 years
- 1-5 cm full thickness tear of the supraspinatus and/or infraspinatus tendon(s) that is fully reparable by double row technique as confirmed at surgery
Who cannot join
- A 35 point exclusion criteria covers a variety of shoulder, musculoskeletal and general heath related conditions such as:
- prior shoulder surgery (including rotator cuff repair)
- symptomatic cervical spine disease
- a frozen shoulder-- defined as a loss of passive range of motion (ROM) of more than 20° in any plane compared to the contralateral shoulder
- advanced (grade 3 or 4) glenohumeral arthritis
- worker's compensation cases
- isolated subscapularis tears.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Variation in Humeral Head Bone Marrow Characteristics and Their Associations With Rotator Cuff Repair Healing
This study investigates correlations between humeral head bone marrow characteristics and tendon healing of rotator cuff repairs. The anticipated results would motivate future research aimed to investigate local enrichment or transplantation of connective tissue progenitor cells to augment rotator cuff repair and the pursuit of novel methods of bone marrow screening to preoperatively identify patients with bone marrow characteristics related to rotator cuff repair success or failure.
Read the detailed description
Healing following rotator cuff repair (RCR) remains a significant clinical challenge, and repair failure rates of 20-30% continue to be reported. To date limited attention has been directed toward understanding how intrinsic mechanistic factors may contribute to variable healing rates following RCR. The objective of this proposal is to quantify the variability of the humeral head bone marrow in patients undergoing RCR and test the prognostic significance of the local concentration of connective tissue progenitors (CTPs) for tendon healing. Our approach will be to enroll 50 patients undergoing RCR. At the time of RCR, 8 ml of bone marrow will be aspirated from the humeral head for quantitative progenitor cell assays. A core biopsy at the tendon repair footprint will be collected for histologic analysis of bone marrow composition. Tendon healing will be assessed by MRI (Sugaya score) at 6 months follow-up, the timeframe in which majority of re-tears occur The variation of bone marrow characteristics among patients will be described (Aim 1) and their correlation with rotator cuff tendon healing will be investigated (Aim 2). The proposal seeks to shift the investigational paradigm to intrinsic patient biologic factors, a fundamental and under-investigated realm of potential prognostic factors of RCR healing. Demonstrating that humeral head characteristics associate with re-tear after RCR will support future work to develop tools to screen patient bone marrow for characteristics predictive of RCR success or failure and advance novel methods that promote local enrichment or transplantation of progenitor cells to augment RCR.
- Conditions
- Rotator Cuff Tears, Rotator Cuff Repairs
- Keywords
- longitudinal cohort, healing, imaging
- Medical subject headings
- Rotator Cuff Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Tendon healing
Sugaya score, 1-5 classification from MR imaging
Measured: 6 months post-operation
Tendon healing
Tendon retraction (mm) from CT imaging
Measured: 6 months post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start22 Nov 2021
- Primary completion22 Dec 2024
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen Derwin, PhD, The Cleveland Clinic
- Investigators
- Kathleen Derwin, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106088
- Sponsor's protocol ID
- 21-811
- Status last verified
- Apr 2026
- First submitted
- 14 Oct 2021
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variation in Humeral Head Bone Marrow Characteristics and Their Associations With Rotator Cuff Repair Healing
- ClinicalTrials.gov ID
- NCT05106088
- Acronym / sponsor ID
- 21-811
- Conditions
- Rotator Cuff Tears, Rotator Cuff Repairs
- Keywords
- longitudinal cohort, healing, imaging
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 22 Dec 2024 (actual)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 3 Nov 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.
This study investigates correlations between humeral head bone marrow characteristics and tendon healing of rotator cuff repairs. The anticipated results would motivate future research aimed to investigate local enrichment or transplantation of connective tissue progenitor cells to augment rotator cuff repair and the pursuit of novel methods of bone marrow screening to preoperatively identify patients with bone marrow characteristics related to rotator cuff repair success or failure.
Detailed description
Healing following rotator cuff repair (RCR) remains a significant clinical challenge, and repair failure rates of 20-30% continue to be reported. To date limited attention has been directed toward understanding how intrinsic mechanistic factors may contribute to variable healing rates following RCR. The objective of this proposal is to quantify the variability of the humeral head bone marrow in patients undergoing RCR and test the prognostic significance of the local concentration of connective tissue progenitors (CTPs) for tendon healing. Our approach will be to enroll 50 patients undergoing RCR. At the time of RCR, 8 ml of bone marrow will be aspirated from the humeral head for quantitative progenitor cell assays. A core biopsy at the tendon repair footprint will be collected for histologic analysis of bone marrow composition. Tendon healing will be assessed by MRI (Sugaya score) at 6 months follow-up, the timeframe in which majority of re-tears occur The variation of bone marrow characteristics among patients will be described (Aim 1) and their correlation with rotator cuff tendon healing will be investigated (Aim 2). The proposal seeks to shift the investigational paradigm to intrinsic patient biologic factors, a fundamental and under-investigated realm of potential prognostic factors of RCR healing. Demonstrating that humeral head characteristics associate with re-tear after RCR will support future work to develop tools to screen patient bone marrow for characteristics predictive of RCR success or failure and advance novel methods that promote local enrichment or transplantation of progenitor cells to augment RCR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Males or females, 18-75 years, with a 1-5 cm full thickness tear of the supraspinatus and/or infraspinatus tendon(s) requiring surgical repair
Key inclusion criteria (3 listed)
- Males or females
- 18-75 years
- 1-5 cm full thickness tear of the supraspinatus and/or infraspinatus tendon(s) that is fully reparable by double row technique as confirmed at surgery
Key exclusion criteria (7 listed)
- A 35 point exclusion criteria covers a variety of shoulder, musculoskeletal and general heath related conditions such as:
- prior shoulder surgery (including rotator cuff repair)
- symptomatic cervical spine disease
- a frozen shoulder-- defined as a loss of passive range of motion (ROM) of more than 20° in any plane compared to the contralateral shoulder
- advanced (grade 3 or 4) glenohumeral arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tendon healing
Time frame: 6 months post-operation
Sugaya score, 1-5 classification from MR imaging
Tendon healing
Time frame: 6 months post-operation
Tendon retraction (mm) from CT imaging
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- 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.
Kathleen Derwin, PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tears and Rotator Cuff Repairs, run by The Cleveland Clinic 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 3 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Tendon healing (time frame: 6 months post-operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2026.