Rotation Medical Bioinductive Implant Database Registry (REBUILD)

October 15, 2021 updated by: Smith & Nephew, Inc.

Rotation MEdical BioindUctive ImpLant Database (REBUILD) Registry

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
483

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • Orthopaedic Specialty Institute
    • Colorado
      • Glenwood Springs, Colorado, United States, 81601
        • Glenwood Orthopaedic Center
    • Florida
      • Gulf Breeze, Florida, United States, 32561
        • Andrews Research & Education Foundation
      • Gulf Breeze, Florida, United States, 32561
        • Andrews Sports Medicine & Orthopaedic Center
      • Jacksonville, Florida, United States, 32204
        • Jacksonville Orthopaedic Institute
      • Sarasota, Florida, United States, 34239
        • Schofield, Hand, & Bright Orthopaedics
    • Georgia
      • Rome, Georgia, United States, 30165
        • Harbin Clinic Orthopaedics & Sports Medicine Rome
    • Illinois
      • Rockford, Illinois, United States, 61107
        • OrthoIllinois, LTD
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • Norton Orthopaedic & Sports
    • Massachusetts
      • North Chelmsford, Massachusetts, United States, 01863
        • Orthopaedic Surgical Associates
    • Michigan
      • Saint Clair Shores, Michigan, United States, 48080
        • Advanced Orthopedics of Detroit, PC
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Atlantic Orthopaedics & Sports Medicine
    • New Jersey
      • Burlington, New Jersey, United States, 08016
        • Lourdes Medical Associates (LMA) Professional
    • New York
      • Setauket, New York, United States, 11733
        • Stony Brook Orthopaedics
      • White Plains, New York, United States, 10606
        • Westchester Medical Pavilion
    • Ohio
      • Columbus, Ohio, United States, 43240
        • Hand and Microsurgery Associates
    • Texas
      • Bryan, Texas, United States, 77802
        • Central Texas Sports Medicine & Orthopaedics, PA
      • Houston, Texas, United States, 77030
        • Bone & Joint Clinic Of Houston
      • Plano, Texas, United States, 75093
        • Plano Orthopedic Sports Medicine & Spine Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This clinical registry will be a prospective, multi-center registry conducted under a common protocol where all subjects will undergo treatment with the Rotation Medical bioinductive implant.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Partial or full-thickness rotator cuff tear
Rotation Medical bioinductive implant
Device: Bioinductive implant
Other Names:
  • Rotation Medical Rotator Cuff System™

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Shoulder pain
Time Frame: 1 year
Change between baseline and post-operative shoulder pain over time using a Visual Analog Scale (VAS).
1 year
American Shoulder and Elbow Surgeons Standardized Form for the Assessment of the Shoulder (ASES)
Time Frame: 1 year
Change between baseline and post-operative ASES shoulder score over time.
1 year
Single Assessment Numeric Evaluation (SANE) Score
Time Frame: 1 year
Change between baseline and post-operative SANE score over time.
1 year
Veterans RAND 12 Item Health Survey (VR-12)
Time Frame: 1 year
Change between baseline and post-operative VR-12 score over time.
1 year
Western Ontario Rotator Cuff Index (WORC)
Time Frame: 1 Year
Change between baseline and post-operative WORC score over time.
1 Year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety assessed by number of Adverse Events and Serious Adverse Events.
Time Frame: 1 Year
Safety will be evaluated by reporting any Adverse Events that occur over the duration of the study and calculating the overall occurrence rate of Adverse Events and Serious Adverse Events
1 Year
Recovery by cumulative number of days shoulder is in a sling
Time Frame: 1 Year
1 Year
Recovery by cumulative time in days between discharge and return to work.
Time Frame: 1 Year
1 Year
Recovery by cumulative time between discharge and return to driving
Time Frame: 1 Year
1 Year
Recovery by cumulative time days between discharge and return to overhead-throwing and non-overhead throwing sports
Time Frame: 1 Year
Overhead-throwing sports overhead-throwing (e.g., baseball, football or exercise where arm extends above head) and non-overhead-throwing (e.g., running, bowling or exercise where arm DOES NOT extend above head) sports.
1 Year
Recovery by cumulative number physical therapy (PT) visits to rehabilitate the index shoulder.
Time Frame: 1 Year
1 Year
Recovery by cumulative number of days of narcotic medication use to manage post-operative shoulder pain.
Time Frame: 1 Year
1 Year
Recovery by cumulative number corticosteroid injections used to manage post-operative shoulder pain.
Time Frame: 1 Year
1 Year
Revision Surgery
Time Frame: 1 Year
Number of participants with a revision surgery.
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Smith & Nephew, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Louis McIntyre, MD, Phelps Medical Associates

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 25, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 16, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 16, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 27, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3679-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings