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

NCT05106088 | Active Not Recruiting

• 1 other identifier: 21-811
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 pursuit of novel methods of bone marrow screening to preoperatively identify patients with bone marrow characteristics related to rotator cuff repair success or failure.

Conditions

Rotator Cuff Repairs; Rotator Cuff Tears

Keywords

longitudinal cohort, healing, imaging

Outcome Measures

Primary Outcomes (2)

• 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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Males or females
• years
• cm full thickness tear of the supraspinatus and/or infraspinatus tendon(s) that is fully reparable by double row technique as confirmed at surgery

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

At the time of rotator cuff repair, 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.

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Kathleen Derwin, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Staff Scientist

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: November 3, 2021
• Study Start: November 22, 2021
• Primary Completion: December 22, 2024
• Study Completion (Estimated): June 30, 2029
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)