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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05106088

Enrollment

Registered

2021-11-03

Start date

2021-11-22

Completion date

2029-06-30

Last updated

2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff Repairs, Rotator Cuff Tears

Keywords

longitudinal cohort, healing, imaging

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Tendon healing	6 months post-operation	Sugaya score, 1-5 classification from MR imaging

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKathleen Derwin, PhD

The Cleveland Clinic

Outcome results