Rotator Cuff TearNCT00957255
Rotator Cuff Repair (RCR) With and Without OrthoADAPT Augmentation
A study testing OrthoADAPT in people with Rotator Cuff Tear, run by Baxter Healthcare Corporation at 1 site in United States.
Trial summary
Prospective, randomized, multi-center, controlled study for patients undergoing open rotator cuff repair. Patients are stratified based on tear size to one of three groups. Each group is then randomized 1:1 to either repair with OrthoADAPT or repair without OrthoADAPT. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- OrthoADAPT
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Apr 2010
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18-70
- MRI confirmed full thickness or high grade partial thickness rotator cuff tear equal or more than 1 cm and involving the supraspinatus and/or infraspinatus tendons
- Tear is repairable by surgery using protocol prescribed fixation procedure
- Patient is able to sign and IRB approved study informed consent
- Patient is willing and able to return for follow-up appointments and study related procedures
- Patient is willing to comply with prescribed physical therapy regimen
Who cannot join
- Emergency, poly trauma patients
- Prior same shoulder surgery including rotator cuff repair except prior subacromial decompression or distal clavicle resection
- Shoulder pathology requiring concomitant procedures during the rotator cuff repair including Labral repair, anterior or posterior stabilization, and/or capsular plication or shift
- Cervical spine disease
- History of adhesive capsulitis in either shoulder
- Patient whose injury does or may involve litigation
Show all 17Show fewer
- Diabetics
- Rotator cuff tear cannot be repaired by primary surgical means including superiorly migrated humeral head, retracted rotator cuff that cannot be mobilized to humeral head, end stage tears, rotator cuff tissue cannot retain sutures, any comorbidities that would directly or indirectly affect the reparability of the cuff
- Patients with grade 3 or 4 glenohumeral arthritis
- Patients with systemic collage disease
- Patients with a known hypersensitivity to equine derived materials
- Active or latent infection
- Chronic use of immunosuppressive agents
- Any oral or IM NSAID usage within 5 days before surgery
- Cancer patients
- Decisional impaired patients
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Medical Research Foundation
Seattle, Washington, 98104
About this study
Prospective, randomized, multi-center, controlled study for patients undergoing open rotator cuff repair. Patients are stratified based on tear size to one of three groups. Each group is then randomized 1:1 to either repair with OrthoADAPT or repair without OrthoADAPT.
- Conditions
- Rotator Cuff Tear
- Being tested
- OrthoADAPT, Standard of care
- Keywords
- rotator cuff tear, rotator cuff repair
- 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.
OrthoADAPTDevice
soft tissue augmentation device
Standard of careProcedure or surgery
Standard of care rotator cuff repair
| Study group | Role | What they receive |
|---|---|---|
| RCR without augmentation | Active comparator | Rotator cuff repair without OrthoADAPT augmentation Receives: Procedure: Standard of care |
| RCR with augmentation | Experimental | Rotator cuff repair with OrthoADAPT augmentation Receives: Device: OrthoADAPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Passive and active range of motion
Measured: Pre-op, 6 weeks, 3, 4, 6, 12, and 24 months
American Shoulder and Elbow Surgeons assessment score
Measured: Pre-op, 6 weeks, 3, 4, 6, 12, and 24 months
Constant shoulder score
Measured: Pre-op, 6 weeks, 3, 4, 6, 12, and 24 months
Pain
Measured: Pre-op, 2, 3, 4, and 6 weeks, 3, 4, 6, 12 and 24 months
Secondary outcomes (3)
MRI
Measured: 12 months
Rotator cuff re-rupture and adhesions
Measured: 6 weeks, 3, 4, 6, 12 and 24 months
Incidence of device or procedure related adverse events
Measured: 6 weeks, 3, 4, 6, 12, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2009 (estimated)
- Study startMar 2009
- Primary completionApr 2010
- Study completionApr 2010
Why it stopped: Funding withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Synovis Surgical Innovations
- Responsible party
- Sponsor
- Investigators
- Charles DePaolo, MD, Principal investigator, Mission Health Research InstitutePierce Scranton, MD, Principal investigator, Seattle Medical Research FoundationWilliam Bryan, MD, Principal investigator, Methodist Center for Orthopedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957255
- Sponsor's protocol ID
- O-0803
- Status last verified
- Apr 2017
- First submitted
- 11 Aug 2009
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotator Cuff Repair (RCR) With and Without OrthoADAPT Augmentation
- ClinicalTrials.gov ID
- NCT00957255
- Acronym / sponsor ID
- O-0803
- Conditions
- Rotator Cuff Tear
- Keywords
- rotator cuff tear, rotator cuff repair
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Synovis Surgical Innovations
- Study start
- Mar 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 12 Aug 2009 (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.
Prospective, randomized, multi-center, controlled study for patients undergoing open rotator cuff repair. Patients are stratified based on tear size to one of three groups. Each group is then randomized 1:1 to either repair with OrthoADAPT or repair without OrthoADAPT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RCR without augmentation | Active comparator | Procedure: Standard of careRotator cuff repair without OrthoADAPT augmentation |
| RCR with augmentation | Experimental | Device: OrthoADAPTRotator cuff repair with OrthoADAPT augmentation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ages 18-70
- MRI confirmed full thickness or high grade partial thickness rotator cuff tear equal or more than 1 cm and involving the supraspinatus and/or infraspinatus tendons
- Tear is repairable by surgery using protocol prescribed fixation procedure
- Patient is able to sign and IRB approved study informed consent
- Patient is willing and able to return for follow-up appointments and study related procedures
Key exclusion criteria (17 listed)
- Emergency, poly trauma patients
- Prior same shoulder surgery including rotator cuff repair except prior subacromial decompression or distal clavicle resection
- Shoulder pathology requiring concomitant procedures during the rotator cuff repair including Labral repair, anterior or posterior stabilization, and/or capsular plication or shift
- Cervical spine disease
- History of adhesive capsulitis in either shoulder
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 |
|---|---|---|
| OrthoADAPTsoft tissue augmentation device | Device | RCR with augmentation |
| Standard of careStandard of care rotator cuff repair | Procedure or surgery | RCR without augmentation |
Primary outcome
Passive and active range of motion
Time frame: Pre-op, 6 weeks, 3, 4, 6, 12, and 24 months
American Shoulder and Elbow Surgeons assessment score
Time frame: Pre-op, 6 weeks, 3, 4, 6, 12, and 24 months
Constant shoulder score
Time frame: Pre-op, 6 weeks, 3, 4, 6, 12, and 24 months
Pain
Time frame: Pre-op, 2, 3, 4, and 6 weeks, 3, 4, 6, 12 and 24 months
3 secondary outcomes
MRI
Time frame: 12 months
Rotator cuff re-rupture and adhesions
Time frame: 6 weeks, 3, 4, 6, 12 and 24 months
Incidence of device or procedure related adverse events
Time frame: 6 weeks, 3, 4, 6, 12, and 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
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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.
Charles DePaolo, MD principal investigator
Mission Health Research Institute
Pierce Scranton, MD principal investigator
Seattle Medical Research Foundation
William Bryan, MD principal investigator
Methodist Center for Orthopedic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OrthoADAPT in people with Rotator Cuff Tear, run by Baxter Healthcare Corporation at 1 site 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 6 inclusion and 17 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: withdrawn, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
Passive and active range of motion (time frame: Pre-op, 6 weeks, 3, 4, 6, 12, and 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2017.