Rotation Medical Bioinductive Implant Database Registry

NCT ID: NCT02784600

Last Updated: 2021-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

483 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-25

Study Completion Date

2020-01-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this clinical registry is to prospectively collect and compare preoperative and postoperative patient-reported data using validated shoulder-specific and health-related quality of life (QoL) instruments during real-world use of the Rotation Medical bioinductive implant to treat rotator cuff tears.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rotator Cuff Tear

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Partial or full-thickness rotator cuff tear

Rotation Medical bioinductive implant

Bioinductive implant

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bioinductive implant

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Rotation Medical Rotator Cuff Systemâ„¢

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. At least 21 years of age.
2. Able and willing to provide voluntary consent to Registry participation.
3. Able to read, speak, and understand the English language.

Exclusion Criteria

1\. Hypersensitive to bovine-derived materials.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Louis McIntyre, MD

Role: PRINCIPAL_INVESTIGATOR

Phelps Medical Associates

Rachael Winter

Role: STUDY_CHAIR

Smith & Nephew, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Orthopaedic Specialty Institute

Orange, California, United States

Site Status

Glenwood Orthopaedic Center

Glenwood Springs, Colorado, United States

Site Status

Andrews Research & Education Foundation

Gulf Breeze, Florida, United States

Site Status

Andrews Sports Medicine & Orthopaedic Center

Gulf Breeze, Florida, United States

Site Status

Jacksonville Orthopaedic Institute

Jacksonville, Florida, United States

Site Status

Schofield, Hand, & Bright Orthopaedics

Sarasota, Florida, United States

Site Status

Harbin Clinic Orthopaedics & Sports Medicine Rome

Rome, Georgia, United States

Site Status

OrthoIllinois, LTD

Rockford, Illinois, United States

Site Status

Norton Orthopaedic & Sports

Louisville, Kentucky, United States

Site Status

Orthopaedic Surgical Associates

North Chelmsford, Massachusetts, United States

Site Status

Advanced Orthopedics of Detroit, PC

Saint Clair Shores, Michigan, United States

Site Status

Atlantic Orthopaedics & Sports Medicine

Portsmouth, New Hampshire, United States

Site Status

Lourdes Medical Associates (LMA) Professional

Burlington, New Jersey, United States

Site Status

Stony Brook Orthopaedics

Setauket, New York, United States

Site Status

Westchester Medical Pavilion

White Plains, New York, United States

Site Status

Hand and Microsurgery Associates

Columbus, Ohio, United States

Site Status

Central Texas Sports Medicine & Orthopaedics, PA

Bryan, Texas, United States

Site Status

Bone & Joint Clinic of Houston

Houston, Texas, United States

Site Status

Plano Orthopedic Sports Medicine & Spine Center

Plano, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

McIntyre LF, Bishai SK, Brown PB 3rd, Bushnell BD, Trenhaile SW. Patient-Reported Outcomes After Use of a Bioabsorbable Collagen Implant to Treat Partial and Full-Thickness Rotator Cuff Tears. Arthroscopy. 2019 Aug;35(8):2262-2271. doi: 10.1016/j.arthro.2019.02.019. Epub 2019 Jul 23.

Reference Type DERIVED
PMID: 31350082 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

3679-01

Identifier Type: -

Identifier Source: org_study_id