Rotator Cuff TearREBUILDNCT02784600
Rotation Medical Bioinductive Implant Database Registry
An observational study of Rotator Cuff Tear, run by Smith & Nephew, Inc. at 19 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Bioinductive implant
- Type of treatment
- Medical device
- How many people
- 483 participants
- Where
- 19 sitesUnited States
- Study dates
- 25 Apr 2016to 16 Jan 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- At least 21 years of age.
- Able and willing to provide voluntary consent to Registry participation.
- Able to read, speak, and understand the English language.
Who cannot join
- 1. Hypersensitive to bovine-derived materials.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Central Texas Sports Medicine & Orthopaedics, PA
Bryan, Texas, 77802
Lourdes Medical Associates (LMA) Professional
Burlington, New Jersey, 08016
Hand and Microsurgery Associates
Columbus, Ohio, 43240
Glenwood Orthopaedic Center
Glenwood Springs, Colorado, 81601
Andrews Research & Education Foundation
Gulf Breeze, Florida, 32561
Andrews Sports Medicine & Orthopaedic Center
Gulf Breeze, Florida, 32561
Bone & Joint Clinic of Houston
Houston, Texas, 77030
Jacksonville Orthopaedic Institute
Jacksonville, Florida, 32204
Norton Orthopaedic & Sports
Louisville, Kentucky, 40241
Orthopaedic Surgical Associates
North Chelmsford, Massachusetts, 01863
Orthopaedic Specialty Institute
Orange, California, 92868
Plano Orthopedic Sports Medicine & Spine Center
Plano, Texas, 75093
Atlantic Orthopaedics & Sports Medicine
Portsmouth, New Hampshire, 03801
OrthoIllinois, LTD
Rockford, Illinois, 61107
Harbin Clinic Orthopaedics & Sports Medicine Rome
Rome, Georgia, 30165
Advanced Orthopedics of Detroit, PC
Saint Clair Shores, Michigan, 48080
Schofield, Hand, & Bright Orthopaedics
Sarasota, Florida, 34239
Stony Brook Orthopaedics
Setauket, New York, 11733
Westchester Medical Pavilion
White Plains, New York, 10606
About this study
Official title: 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.
- Conditions
- Rotator Cuff Tear
- Being tested
- Bioinductive implant
- Keywords
- Partial-thickness, Full-thickness
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioinductive implantDevice
Also called Rotation Medical Rotator Cuff System™
| Study group | Role | What they receive |
|---|---|---|
| Partial or full-thickness rotator cuff tear | Rotation Medical bioinductive implant Receives: Device: Bioinductive implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder pain
Change between baseline and post-operative shoulder pain over time using a Visual Analog Scale (VAS).
Measured: 1 year
American Shoulder and Elbow Surgeons Standardized Form for the Assessment of the Shoulder (ASES)
Change between baseline and post-operative ASES shoulder score over time.
Measured: 1 year
Single Assessment Numeric Evaluation (SANE) Score
Change between baseline and post-operative SANE score over time.
Measured: 1 year
Veterans RAND 12 Item Health Survey (VR-12)
Change between baseline and post-operative VR-12 score over time.
Measured: 1 year
Western Ontario Rotator Cuff Index (WORC)
Change between baseline and post-operative WORC score over time.
Measured: 1 Year
Secondary outcomes (9)
Safety assessed by number of Adverse Events and Serious Adverse Events.
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
Measured: 1 Year
Recovery by cumulative number of days shoulder is in a sling
Measured: 1 Year
Recovery by cumulative time in days between discharge and return to work.
Measured: 1 Year
Recovery by cumulative time between discharge and return to driving
Measured: 1 Year
Recovery by cumulative time days between discharge and return to overhead-throwing and non-overhead throwing sports
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.
Measured: 1 Year
Recovery by cumulative number physical therapy (PT) visits to rehabilitate the index shoulder.
Measured: 1 Year
Recovery by cumulative number of days of narcotic medication use to manage post-operative shoulder pain.
Measured: 1 Year
Recovery by cumulative number corticosteroid injections used to manage post-operative shoulder pain.
Measured: 1 Year
Revision Surgery
Number of participants with a revision surgery.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study start25 Apr 2016
- Primary completion16 Jan 2020
- Study completion16 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 483 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Louis McIntyre, MD, Principal investigator, Phelps Medical AssociatesRachael Winter, Study chair, Smith & Nephew, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784600
- Sponsor's protocol ID
- 3679-01
- Acronym
- REBUILD
- Status last verified
- Oct 2021
- First submitted
- 18 May 2016
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 31350082
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotation MEdical BioindUctive ImpLant Database (REBUILD) Registry
- ClinicalTrials.gov ID
- NCT02784600
- Acronym / sponsor ID
- REBUILD / 3679-01
- Conditions
- Rotator Cuff Tear
- Keywords
- Partial-thickness, Full-thickness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 483 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Apr 2016 (actual)
- Primary completion
- 16 Jan 2020 (actual)
- Study completion
- 16 Jan 2020 (actual)
- First posted
- 27 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Partial or full-thickness rotator cuff tear | – | Device: Bioinductive implantRotation Medical bioinductive implant |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- At least 21 years of age.
- Able and willing to provide voluntary consent to Registry participation.
- Able to read, speak, and understand the English language.
Key exclusion criteria (1 listed)
- 1. Hypersensitive to bovine-derived materials.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioinductive implantAlso: Rotation Medical Rotator Cuff System™ | Device | Partial or full-thickness rotator cuff tear |
Primary outcome
Shoulder pain
Time frame: 1 year
Change between baseline and post-operative shoulder pain over time using a Visual Analog Scale (VAS).
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.
Single Assessment Numeric Evaluation (SANE) Score
Time frame: 1 year
Change between baseline and post-operative SANE score over time.
Veterans RAND 12 Item Health Survey (VR-12)
Time frame: 1 year
Change between baseline and post-operative VR-12 score over time.
Western Ontario Rotator Cuff Index (WORC)
Time frame: 1 Year
Change between baseline and post-operative WORC score over time.
9 secondary outcomes
Safety assessed by number of Adverse Events and Serious Adverse Events.
Time frame: 1 Year
Recovery by cumulative number of days shoulder is in a sling
Time frame: 1 Year
Recovery by cumulative time in days between discharge and return to work.
Time frame: 1 Year
Recovery by cumulative time between discharge and return to driving
Time frame: 1 Year
Recovery by cumulative time days between discharge and return to overhead-throwing and non-overhead throwing sports
Time frame: 1 Year
Recovery by cumulative number physical therapy (PT) visits to rehabilitate the index shoulder.
Time frame: 1 Year
Recovery by cumulative number of days of narcotic medication use to manage post-operative shoulder pain.
Time frame: 1 Year
Recovery by cumulative number corticosteroid injections used to manage post-operative shoulder pain.
Time frame: 1 Year
Revision Surgery
Time frame: 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
- Derived from this study: PubMed 31350082McIntyre 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis McIntyre, MD principal investigator
Phelps Medical Associates
Rachael Winter study chair
Smith & Nephew, Inc.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tear, run by Smith & Nephew, Inc. at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder pain (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02784600, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2021.