Rotator Cuff TearsNCT05458349
Acellular Dermis in Rotator Cuff Repair
A study testing acellular dermis in people with Rotator Cuff Tears and Rotator Cuff Injuries, run by The Royal Orthopaedic Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
To determine if an acellular dermal graft (ADG) will incorporate into the rotator cuff and subsequently improve outcomes without an increase in risk to the patient Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tears, Rotator Cuff Injuries
- What is being tested?
- acellular dermis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Apr 2013to 11 Feb 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic rotator cuff tear that warrants operative intervention.
- A Tear measuring between 1-5cm at arthroscopy.
- An arthroscopic rotator cuff repair.
- Written consent.
Who cannot join
- Rotator cuff tears greater than 5cm and less than 1cm
- Clinical or radiological evidence of osteoarthritis affecting the index side.
- Patients involved in a Compensation claim related to the shoulder.
- Inability to attend follow-up for 1 year and to a repeat MRI scan.
- Previous shoulder surgery or proximal humeral fracture on the index side.
- Patients that are recruited in a current study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Orthopaedic Hospital NHS Trust
Birmingham
About this study
To determine if an acellular dermal graft (ADG) will incorporate into the rotator cuff and subsequently improve outcomes without an increase in risk to the patient
Read the detailed description
Rotator cuff healing poses a significant clinical problem with re-tear rates between 20-50%. The final functional outcome following surgery correlates with healing, with those that completely heal performing best. Failure of repair is mainly due to tendon failure both mechanically and biologically. If the healing and the structural properties of the tendon can be improved then significant functional gains may be achieved. This study will therefore utilise acellular dermal grafts to determine whether they could be used for to improve patient outcomes following surgery
- Conditions
- Rotator Cuff Tears, Rotator Cuff Injuries
- Being tested
- acellular dermis
- Keywords
- rotator cuff, shoulder, surgery, acellular dermal graft, acellular dermis, rotator cuff augmentation
- 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.
acellular dermisDevice
| Study group | Role | What they receive |
|---|---|---|
| dermis group | Experimental | Group will receive standard of care treatment and interventions plus the use of the acellular dermal graft during surgery Receives: Device: acellular dermis |
| control group | No intervention | Group will receive standard of care treatment and interventions but the acellular dermal graft will not be used during surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
rotator cuff healing
Rotator cuff healing on MRI
Measured: 12 month post-surgery
Secondary outcomes (3)
Western Ontario Rotator cuff score
comparison of scores between groups
Measured: 12months
Constant Murley score
comparison of scores between groups
Measured: 12 months
American shoulder and elbow surgeons standardized form
comparison of scores between groups
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start4 Apr 2013
- Primary completion11 Feb 2021
- Study completion11 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies 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
- Parallel groups
- Model description
- It is a Level 1 study, a prospective double blind, randomized controlled trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Royal Orthopaedic Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martyn Mr Snow, MD, Principal investigator, The Royal Orthopaedic Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458349
- Sponsor's protocol ID
- ROH11ORTH09
- Status last verified
- Jul 2022
- First submitted
- 11 Jul 2022
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acellular Dermis in Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT05458349
- Acronym / sponsor ID
- ROH11ORTH09
- Conditions
- Rotator Cuff Tears, Rotator Cuff Injuries
- Keywords
- rotator cuff, shoulder, surgery, acellular dermal graft, acellular dermis, rotator cuff augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- The Royal Orthopaedic Hospital NHS TrustUniversity, hospital or other
- Study start
- 4 Apr 2013 (actual)
- Primary completion
- 11 Feb 2021 (actual)
- Study completion
- 11 Feb 2021 (actual)
- First posted
- 14 Jul 2022 (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.
To determine if an acellular dermal graft (ADG) will incorporate into the rotator cuff and subsequently improve outcomes without an increase in risk to the patient
Detailed description
Rotator cuff healing poses a significant clinical problem with re-tear rates between 20-50%. The final functional outcome following surgery correlates with healing, with those that completely heal performing best. Failure of repair is mainly due to tendon failure both mechanically and biologically. If the healing and the structural properties of the tendon can be improved then significant functional gains may be achieved. This study will therefore utilise acellular dermal grafts to determine whether they could be used for to improve patient outcomes following surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- It is a Level 1 study, a prospective double blind, randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| dermis group | Experimental | Device: acellular dermisGroup will receive standard of care treatment and interventions plus the use of the acellular dermal graft during surgery |
| control group | No intervention | –Group will receive standard of care treatment and interventions but the acellular dermal graft will not be used during surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Symptomatic rotator cuff tear that warrants operative intervention.
- A Tear measuring between 1-5cm at arthroscopy.
- An arthroscopic rotator cuff repair.
- Written consent.
Key exclusion criteria (6 listed)
- Rotator cuff tears greater than 5cm and less than 1cm
- Clinical or radiological evidence of osteoarthritis affecting the index side.
- Patients involved in a Compensation claim related to the shoulder.
- Inability to attend follow-up for 1 year and to a repeat MRI scan.
- Previous shoulder surgery or proximal humeral fracture on the index side.
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 |
|---|---|---|
| acellular dermis | Device | dermis group |
Primary outcome
rotator cuff healing
Time frame: 12 month post-surgery
Rotator cuff healing on MRI
3 secondary outcomes
Western Ontario Rotator cuff score
Time frame: 12months
Constant Murley score
Time frame: 12 months
American shoulder and elbow surgeons standardized form
Time frame: 12 months
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 14 Jul 2022.
- 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.
Martyn Mr Snow, MD principal investigator
The Royal Orthopaedic Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acellular dermis in people with Rotator Cuff Tears and Rotator Cuff Injuries, run by The Royal Orthopaedic Hospital NHS Trust at 1 site in United Kingdom.
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 4 inclusion and 6 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 14 Jul 2022. 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 Kingdom. 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?
rotator cuff healing (time frame: 12 month post-surgery). 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 14 Jul 2022.