A Clinical Study to Evaluate the Safety and Efficacy of the Clinical Application of a Human-Derived Collagen Patch in Patients Undergoing Surgical Repair of Repairable Rotator Cuff Tears

Effect of Atelocollagen Pouch-Type Scaffold in Patients with Repairable Rotator Cuff Tears: A Prospective, Single-Center, Single-Blinded, Randomized Investigator-Initiated Pilot Study Protocol

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011399

Enrollment

Registered

2026-01-02

Start date

2025-12-31

Completion date

Unknown

Last updated

2026-01-05

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 : Product Name: ARC Korea Co., Ltd. Polygen, Collagen-Based Tissue Augmentation Material, PG-2010 Instructions for Use: Verify the integrity of the product packaging and ensure that

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adults aged 19 years or older with repairable full-thickness rotator cuff tears who are scheduled to undergo arthroscopic rotator cuff repair and who have voluntarily provided written informed consent to participate in the clinical trial.

Exclusion criteria

Exclusion criteria: Exclusion Criteria Patients with a history of surgery on the same shoulder. Patients with concomitant infection or neuropathy. Patients with irreparable massive rotator cuff tears. Patients with rotator cuff disease associated with glenohumeral arthritis. Patients with mental or neurological conditions that would preclude obtaining informed consent or completing follow-up assessments. Patients with a history of medications or treatments that may affect the rotator cuff, including prolotherapy, platelet-rich plasma (PRP), polydeoxyribonucleotide (PDRN), or shoulder injections, within 4 weeks prior to surgery.

Design outcomes

Primary

Measure	Time frame
The change in the UCLA (University of California, Los Angeles) score from preoperative baseline to 12 months after surgery.;Change in the Constant (Constant–Murley Shoulder) score from preoperative baseline to 12 months postoperatively;Change in the VAS ( Visual analog scale) score from preoperative baseline to 12 months postoperatively;Change in range of motion (ROM) score from preoperative baseline to 12 months postoperatively;Change in overall patient satisfaction from preoperative baseline to 12 months postoperatively;Incidence of re-tear (%) evaluated using follow-up MRI at 6 months after surgery;Change in the ASES (American Shoulder and Elbow Surgeons) score from preoperative baseline to 12 months postoperatively;Change in the SST (Simple Shoulder Test) score from preoperative baseline to 12 months postoperatively;Re-tear rate assessed by ultrasonography at 12 months postoperatively compared with the preoperative status	—

Measure

Time frame

The change in the UCLA (University of California, Los Angeles) score from preoperative baseline to 12 months after surgery.;Change in the Constant (Constant–Murley Shoulder) score from preoperative baseline to 12 months postoperatively;Change in the VAS ( Visual analog scale) score from preoperative baseline to 12 months postoperatively;Change in range of motion (ROM) score from preoperative baseline to 12 months postoperatively;Change in overall patient satisfaction from preoperative baseline to 12 months postoperatively;Incidence of re-tear (%) evaluated using follow-up MRI at 6 months after surgery;Change in the ASES (American Shoulder and Elbow Surgeons) score from preoperative baseline to 12 months postoperatively;Change in the SST (Simple Shoulder Test) score from preoperative baseline to 12 months postoperatively;Re-tear rate assessed by ultrasonography at 12 months postoperatively compared with the preoperative status

—

Secondary

Measure	Time frame
Assessment of adverse drug reactions	—

Countries

Korea, Republic of

Contacts

Public Contactmihyeon jeong

Korea University Anam Hospital

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

Outcome results