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Clinical Study on Bone Morphogenetic Protein (BMP) for Enhancing Tendon-to-Bone Healing in Rotator Cuff Repair: A Randomized Controlled Trial

A Clinical Study on Bone Morphogenetic Protein (BMP) for Promoting Tendon-to-Bone Healing in Rotator Cuff Repair

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118568
Enrollment
Unknown
Registered
2026-02-09
Start date
2022-01-27
Completion date
Unknown
Last updated
2026-02-16

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

Conditions

Rotator cuff injury

Interventions

Experimental group:The tendon-bone interface at the rotator cuff footprint area received an injection of BMP material.
Control group:The tendon-bone interface at the rotator cuff footprint area did not receive an injection of BMP material.

Sponsors

Northern Jiangsu People's Hospital Affiliated to Yangzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Aged between 18 and 75 years. Diagnosis of a symptomatic rotator cuff tear confirmed by both preoperative MRI and intraoperative arthroscopy. Patients with an inadequate response to at least 3 months of structured conservative treatment (e.g., physical therapy, NSAIDs, and activity modification). Ability to understand and provide informed consent for the study protocol. Willingness and ability to comply with the standardized postoperative rehabilitation protocol and complete the scheduled follow-up assessments.

Exclusion criteria

Exclusion criteria: Combined with shoulder instability, shoulder arthritis, periarthritic fracture dislocation, or nerveinjury. MRI evaluation of rotator cuff muscle atrophy and fat infiltration, the supraspinatus muscle tangential sign is positive, or the Goutallier grade > III. Shoulder previous surgical history. Those who were mentally disturbed.

Design outcomes

Primary

MeasureTime frame
Joint range of motion;Magnetic resonance imaging (MRI);visual analogue scale (VAS);American Shoulder and Elbow Surgeons (ASES);Constant-Murley score;

Secondary

MeasureTime frame
scapular plane abduction strength;

Countries

China

Contacts

Public ContactFei Wenyong

Northern Jiangsu People's Hospital Affiliated to Yangzhou University

fwy202406@163.com+86 180 5106 1779

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 15, 2026