A clinical study to evaluate the safety and efficacy of human-derived collagen for clinical application in patients undergoing surgery for repairable rotator cuff tears

Effect of human-derived collagen in patients with repairable rotator cuff tear : Prospective, Single-center, Single-blinded, Randomized, Investigator Initiated Pilot Protocol

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0010583

Enrollment

Registered

2025-06-04

Start date

2022-08-16

Completion date

Unknown

Last updated

2025-06-24

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

Conditions

None listed

Interventions

Medical Device : This clinical trial is a prospective, single-center, single-blind, randomized, controlled, exploratory investigator-initiated study. Participants who voluntarily provide written info

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 1. Adults aged 19 years or older. 2. Patients with a full-thickness rotator cuff tear, who are scheduled to undergo arthroscopic rotator cuff repair surgery, and have provided written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: Patients with a history of surgery on the same site Patients with concomitant infection or neuropathy Patients with extensive rotator cuff tears that are not amenable to suturing Patients with rotator cuff pathology accompanied by arthritis Patients with mental or neurological conditions severe enough to prevent obtaining informed consent or performing follow-up evaluations Patients with a history of medications or treatments that may affect the rotator cuff, including prolotherapy, PRP (Platelet-Rich Plasma), or PDRN (Polydeoxyribonucleotide) injections to the shoulder within 4 weeks prior to surgery !

Design outcomes

Primary

Measure	Time frame
Change in UCLA (University of California, Los Angeles) Shoulder Score from Preoperative to 12 Months Postoperative;Changes in the Constant-Murley Shoulder Score from Preoperative to 12 Months Postoperative;Changes in pain intensity measured by the Visual Analogue Scale (VAS) from preoperative to 12 months postoperative;Changes in Range of Motion (ROM) from preoperative to 12 months postoperative;Overall patient satisfaction at 12 months postoperatively;Re-tear rates (%) detected by ultrasound at 3, 6, and 12 months postoperatively compared to 1 month after surgery;Re-tear rate (%) detected by follow-up magnetic resonance imaging (MRI) at 6 months postoperatively;Changes in the ASES(American Shoulder and Elbow Surgeons Standardized) score from Preoperative to 12 Months Postoperative;Changes in the SST(Simple Shoulder Test) score from Preoperative to 12 Months Postoperative	—

Measure

Time frame

Change in UCLA (University of California, Los Angeles) Shoulder Score from Preoperative to 12 Months Postoperative;Changes in the Constant-Murley Shoulder Score from Preoperative to 12 Months Postoperative;Changes in pain intensity measured by the Visual Analogue Scale (VAS) from preoperative to 12 months postoperative;Changes in Range of Motion (ROM) from preoperative to 12 months postoperative;Overall patient satisfaction at 12 months postoperatively;Re-tear rates (%) detected by ultrasound at 3, 6, and 12 months postoperatively compared to 1 month after surgery;Re-tear rate (%) detected by follow-up magnetic resonance imaging (MRI) at 6 months postoperatively;Changes in the ASES(American Shoulder and Elbow Surgeons Standardized) score from Preoperative to 12 Months Postoperative;Changes in the SST(Simple Shoulder Test) score from Preoperative to 12 Months Postoperative

—

Secondary

Measure	Time frame
Adverse Drug Reaction (ADR) Assessment	—

Countries

Korea, Republic of

Contacts

Public Contactmihyeon jeong

Korea University Anam Hospital

aakmcssos003@kumc.or.kr+82-2-920-6176

Outcome results