Zimmer ActivBraid Rotator Cuff Repair (RCR) Study

NeuroTherapia, Inc.

Status: Not yet enrolling

Conditions: Rotator Cuff Repair of the Shoulder

Treatments: Device: ActivBraid™Collagen Co-Braid suture (Zimmer Biomet)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06971497

25-252

Details and patient eligibility

About

We will enroll up to 65 patients undergoing primary arthroscopic rotator cuff repair (RCR) using ActivBraid™Collagen Co-Braid suture (Zimmer Biomet) and evaluate RCR healing as well as shoulder range of motion, strength, and patient-reported outcomes at 6m, 1y and 2y.

Enrollment: 65 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-75 years
• acute or chronic, reparable, 1-5 cm full thickness tear of the supraspinatus and/or infraspinatus tendons

Exclusion criteria

• prior ipsilateral shoulder surgery
• outstanding worker's compensation claim
• symptomatic cervical spine disease
• a frozen shoulder
• advanced glenohumeral arthritis
• isolated subscapularis tear
• significant radiation exposure for other medical reasons.
• known is advance to be claustrophobic
• known history of hypersensitivity to bovine-derived materials.

Trial design

65 participants in 1 patient group

patients undergoing primary arthroscopic rotator cuff repair

Description:

Patients undergoing primary arthroscopic rotator cuff repair will have their repair completed with ActivBraid™Collagen Co-Braid suture (Zimmer Biomet).

Treatment:

Device: ActivBraid™Collagen Co-Braid suture (Zimmer Biomet)