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Recruiting NCT06971497

Zimmer ActivBraid Rotator Cuff Repair (RCR) Study

— Observational Rotator Cuff Repair of the Shoulder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ActivBraid™Collagen Co-Braid suture (Zimmer Biomet).
Who it may be relevant to
Registry conditions: Rotator Cuff Repair of the Shoulder. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Cleveland Clinic ActivBraid Rotator Cuff Repair (RCR) Study

Overview

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.

Interventions

  • Device ActivBraid™Collagen Co-Braid suture (Zimmer Biomet)
    ActivBraid™ is a suture made from approximately half ultra-high molecular weight polyethylene and and half collagen derived from cow skin. Collagen is the most abundant protein in our bodies and serves as the building block for tendons and bones. The collagen in ActivBraid™ is intended to enhance cell attachment and tissue integration which may improve the healing of a rotator cuff repair. ActivBraid™ suture has been shown to have equivalent strength as other high strength sutures used in orthop

Primary outcome measures

  • Rotator cuff repair healing [Time frame: 1 year post-operation]
  • Rotator cuff repair healing [Time frame: 1 year post-operation]
Secondary outcome measures (3)
  • Patient-reported outcome measures [Time frame: 1 year post-operation]
  • Shoulder strength [Time frame: 1 year post-operation]
  • Shoulder range of motion [Time frame: 1 year post-operation]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 2 centers
  • Cleveland Clinic — Cleveland
  • Cleveland Clinic — Cleveland

Identifiers

NCT: NCT06971497 · 25-252

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗