Variation in Humeral Head Bone Marrow Characteristics With Rotator Cuff Repair Healing

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Rotator Cuff Tears; Rotator Cuff Repairs

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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tendon healing	Sugaya score, 1-5 classification from MR imaging	6 months post-operation
Tendon healing	Tendon retraction (mm) from CT imaging	6 months post-operation

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Kathleen Derwin, PhD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2021
• Primary Completion (Actual): December 22, 2024
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: October 14, 2021
• First Submitted That Met QC Criteria: October 25, 2021
• First Posted (Actual): November 3, 2021

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: longitudinal cohort, healing, imaging
• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: 21-811

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No