The effect of Bone Morphogenetic Protein 2 (BMP-2) for anterior shoulder instability after arthroscopic capsulolabral repair

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011233

Enrollment

Registered

2025-11-28

Start date

2025-11-17

Completion date

Unknown

Last updated

2025-12-08

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

Conditions

None listed

Interventions

Procedure/Surgery : In patients who meet the indications for anterior shoulder instability, recombinant human BMP-2 (rhBMP-2

NOVOSIS 1 g, CGBIO) and ß-tricalcium phosphate (ß-TCP

EXCELLOS 1.5 g, CGBIO) will be applied following arthroscopic capsulolabral repair. For the control group, a retrospective medical record review will be conducted in adult patients who underwent arth

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Shoulder pain or symptoms of instability (including a positive apprehension test). Preoperative shoulder CT or MRI showing glenoid bone loss of 25% or less.

Exclusion criteria

Exclusion criteria: ? Patients with a glenoid rim fracture (e.g., bony Bankart, bony ALPSA) ? Patients with a previous surgical history on the ipsilateral shoulder ? Patients younger than 19 years of age ? Patients without preoperative or postoperative (minimum 6 months) follow-up shoulder CT imaging ? Patients with less than 6 months of postoperative clinical follow-up ? Pregnant patients ? Patients with known hypersensitivity to rhBMP-2 ? Patients with infection at the surgical site ? Patients with a history of tumor resection at the graft site ? Patients undergoing active chemotherapy ? Skeletally immature patients (younger than 18 years or with open physes) ? Patients with glenoid bone loss greater than 25% requiring alternative procedures such as the Latarjet ? Patients with uncontrolled seizures or generalized hypotonia

Design outcomes

Primary

Measure	Time frame
Rowe Rating Scale for Shoulder Instability	—

Secondary

Measure	Time frame
Range of motion;Visual Analog Scale (VAS) for pain;Glenoid width, bone-loss ratio, and the presence of bone regeneration (MRI or CT or CTA; according to the examiner’s judgment_;ASES (American Shoulder and Elbow Surgeons score), Constant-Murley score, University of California, Los Angeles (UCLA), Simple Shoulder Test(SST) Shoulder Rating Scale,	—

Countries

Korea, Republic of

Contacts

Public ContactHYUNG JUN KOO

Seoul National University Hospital

kgudwns24@naver.com+82-2-2072-2368

Outcome results