Rotator Cuff InjuriesNCT04686396
Demineralized Bone Matrix Rotator Cuff Study
A study testing Demineralized bone matrix in people with Rotator Cuff Injuries, run by Arthrex, Inc. at 1 site in United States.
Trial summary
Patients undergoing rotator cuff repair surgery will experience improved tendon healing with the use of demineralized bone matrix augmentation. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Injuries
- What is being tested?
- Demineralized bone matrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to Sep 2024
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The Subject is between the ages of 40 and 75 years.
- Subject is planning to undergo arthroscopic surgery for full thickness rotator cuff tears (RCT) of supraspinatus and infraspinatus muscles, who are candidates for demineralized bone matrix with BMC.
- Two tendon tear or tear size equal to or greater than 3cm
- Amenable to double-row repair
- Primary rotator cuff tears with or without superior labral tear and/or biceps tear)
Who cannot join
- The Subject is unable or unwilling to sign the Patient Informed Consent, approved by the Institutional Review Board.
- The Subject objects to use of allograft
- Irreparable Rotator Cuff Tear
- Complete full thickness subscapularis tears of > than the superior 1/3 of the tendon (Lafosse grade 3 and above)
- < 2 mm joint space of the glenohumeral joint on either an anteroposterior or axillary radiograph
- Recurrent shoulder instability
Show all 11Show fewer
- Intra-articular injections (steroids) within 1 month of surgery
- RCR revisions
- Subject MRI taken more than 12 months prior to surgery
- Pregnant or planning to become pregnant during the study period
- Workman's compensation case
Trial locations and contacts
1 site in 1 country.
About this study
Patients undergoing rotator cuff repair surgery will experience improved tendon healing with the use of demineralized bone matrix augmentation.
Read the detailed description
This is a prospective randomized study comparing the outcomes of patient undergoing rotator cuff repair with either an interpositional procedure administering demineralized bone matrix (DBM), or a control group without demineralized bone matrix. Patient outcomes will be collected and compared between the two cohorts up to a five (5) year post-operative period and will include a range of subjective and functional outcomes, along with radiographic imaging.
- Conditions
- Rotator Cuff Injuries
- Being tested
- Demineralized bone matrix
- 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.
Demineralized bone matrixDevice
Demineralized bone matrix
| Study group | Role | What they receive |
|---|---|---|
| Interpositional Group | Experimental | Demineralized bone matrix Receives: Device: Demineralized bone matrix |
| Control | No intervention | Without demineralized bone matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI
Rate of healing of the rotator cuff repair
Measured: 24 weeks
Secondary outcomes (4)
American Shoulder and Elbow Surgeons Shoulder Score (ASES score)
Changes in patient self evaluation and physician assessment score
Measured: pretreatment, 24 weeks, 1 year, 2 year and 5 year
Veterans RAND Health (VR-12)
Changes in patient reported general health and mental survey. Average score is 50 (negative answers bring scores down, positive answers bring score up)
Measured: pretreatment, 24 weeks, 1 year, 2 year and 5 year
Single Assessment Numerical Evaluation (SANE)
Changes in patient reported affected shoulder survey base on percentage (0 - 100%, 100% being normal)
Measured: pretreatment, 24 weeks, 1 year, 2 year and 5 year
Visual Analogue Scale (VAS)
Changes in patient reported pain survey. 0 - 10 point scale (0 no pain, 10 worst possible pain)
Measured: pretreatment, 24 weeks, 1 year, 2 year and 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start1 Sep 2019
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff InjuriesStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to have either the addition of demineralized bone matrix to their procedure (Interpositional Group), or standard Rotator Cuff repair without demineralized bone matrix administered (Control group).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arthrex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686396
- Sponsor's protocol ID
- US-1300
- Status last verified
- Dec 2020
- First submitted
- 23 Dec 2020
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demineralized Bone Matrix Rotator Cuff Study
- ClinicalTrials.gov ID
- NCT04686396
- Acronym / sponsor ID
- US-1300
- Conditions
- Rotator Cuff Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Arthrex, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 28 Dec 2020 (actual)
- 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.
Patients undergoing rotator cuff repair surgery will experience improved tendon healing with the use of demineralized bone matrix augmentation.
Detailed description
This is a prospective randomized study comparing the outcomes of patient undergoing rotator cuff repair with either an interpositional procedure administering demineralized bone matrix (DBM), or a control group without demineralized bone matrix. Patient outcomes will be collected and compared between the two cohorts up to a five (5) year post-operative period and will include a range of subjective and functional outcomes, along with radiographic imaging.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be randomized to have either the addition of demineralized bone matrix to their procedure (Interpositional Group), or standard Rotator Cuff repair without demineralized bone matrix administered (Control group).
| Arm | Type | Receives |
|---|---|---|
| Interpositional Group | Experimental | Device: Demineralized bone matrixDemineralized bone matrix |
| Control | No intervention | –Without demineralized bone matrix |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The Subject is between the ages of 40 and 75 years.
- Subject is planning to undergo arthroscopic surgery for full thickness rotator cuff tears (RCT) of supraspinatus and infraspinatus muscles, who are candidates for demineralized bone matrix with BMC.
- Two tendon tear or tear size equal to or greater than 3cm
- Amenable to double-row repair
- Primary rotator cuff tears with or without superior labral tear and/or biceps tear)
Key exclusion criteria (11 listed)
- The Subject is unable or unwilling to sign the Patient Informed Consent, approved by the Institutional Review Board.
- The Subject objects to use of allograft
- Irreparable Rotator Cuff Tear
- Complete full thickness subscapularis tears of > than the superior 1/3 of the tendon (Lafosse grade 3 and above)
- < 2 mm joint space of the glenohumeral joint on either an anteroposterior or axillary radiograph
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 |
|---|---|---|
| Demineralized bone matrixDemineralized bone matrix | Device | Interpositional Group |
Primary outcome
MRI
Time frame: 24 weeks
Rate of healing of the rotator cuff repair
4 secondary outcomes
American Shoulder and Elbow Surgeons Shoulder Score (ASES score)
Time frame: pretreatment, 24 weeks, 1 year, 2 year and 5 year
Veterans RAND Health (VR-12)
Time frame: pretreatment, 24 weeks, 1 year, 2 year and 5 year
Single Assessment Numerical Evaluation (SANE)
Time frame: pretreatment, 24 weeks, 1 year, 2 year and 5 year
Visual Analogue Scale (VAS)
Time frame: pretreatment, 24 weeks, 1 year, 2 year and 5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Demineralized bone matrix in people with Rotator Cuff Injuries, run by Arthrex, Inc. 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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 2 Aug 2021. 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?
Results are not available in the source record.
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?
MRI (time frame: 24 weeks). 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 2 Aug 2021.