Massive Rotator Cuff TearsNCT02049684
SPARC: Shoulder PAtch for Rotator Cuff Tears
An observational study of Massive Rotator Cuff Tears, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Rotator cuff tears (injury to the muscle or tendons which stabilise the shoulder) are one of the most common conditions affecting the shoulder. Small and medium sized rotator cuff tears can be managed with arthroscopic or keyhole surgery. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Massive Rotator Cuff Tears
- What is being tested?
- Patch
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2013to 31 Mar 2018
- 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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Massive rotator cuff tear patients
Who may be able to join
- Ultrasound confirming massive rotator full thickness tear, unacceptable pain and disability following conservative treatment, or previous surgery that has failed, deltoid muscle that is functional, and compliance with post operative rehabilitation.
Who cannot join
- History of infection
- Neurological condition that affects the shoulder girdle
- Presence of rotator cuff arthropathy with stiffness
- Subjects with inability to give informed consent
- Pregnancy or lactation
- Malignancy
Show all 15Show fewer
- Age less than 18 years
- Subjects currently participating in other research studies
- Subjects with the following contraindications to MRI scanning will not have an MR scan but may be asked to have alternative imaging, for example ultrasound:
- Pacemakers
- Surgical clips within the head
- Certain inner ear implants
- Neuroelectrical stimulators
- Metal fragments within the eye or head
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Rotator cuff tears (injury to the muscle or tendons which stabilise the shoulder) are one of the most common conditions affecting the shoulder. Small and medium sized rotator cuff tears can be managed with arthroscopic or keyhole surgery. Very large or massive tears are difficult to operate on and often have poor rates of healing. As a result surgeons have investigated the use of products to improve the outcome of surgery on massive tears.
The product that the investigators are currently using to try to improve the outcome of surgery for massive rotator cuff tears is called a patch. The patch provides a scaffold to support the muscles of the rotator cuff. Studies of rotator cuff surgery using similar patches have found that recovery is improved and there is a lower rate of postsurgical problems. The aim of this study is to look at whether using the patch improves pain and the clinical function of the shoulder after surgery. In addition, the investigators would like to understand how the patch works. To do this the investigators will scan (take images of) the shoulder using magnetic resonance imaging to look at the muscle damage in the shoulder before and after surgery.
- Conditions
- Massive Rotator Cuff Tears
- Being tested
- Patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PatchProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Not described Receives: Procedure: Patch | |
| Physiotherapy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in supraspinatus, infraspinatous and subscapularis water:fat ratio
Change in supraspinatus, infraspinatous and subscapularis water:fat ratio, assessed by MRI, 6 months postsurgery/ physiotherapy compared to baseline (presurgery/physiotherapy)
Measured: Baseline and 6 months post surgery
Secondary outcomes (3)
Change in function, pain and patient satisfaction (Oxford Shoulder Score, EQ5D, Constant Score)
Change in function, pain and patient satisfaction (Oxford Shoulder Score, EQ5D, Constant Score)
Measured: Baseline and 6 months post surgery
Change in muscle volume (MRI assessment) for the supraspinatus, infraspinatous and subscapularis
Change in muscle volume (MRI assessment) for the supraspinatus, infraspinatous and subscapularis
Measured: Baseline and 6 months post-surgery
Change in Goutallier score of muscle atrophy and fatty infiltration (MRI assessment) for the supraspinatus, infraspinatous and subscapularis
Change in Goutallier score of muscle atrophy and fatty infiltration (MRI assessment) for the supraspinatus, infraspinatous and subscapularis
Measured: Baseline and 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study start1 Jan 2013
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Massive 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049684
- Sponsor's protocol ID
- OR11/10063
- Other IDs
- 13/YH/0030
- Status last verified
- Aug 2019
- First submitted
- 23 Jan 2014
- Last updated
- 19 Aug 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPARC: Shoulder PAtch for Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT02049684
- Acronym / sponsor ID
- OR11/10063
- Conditions
- Massive Rotator Cuff Tears
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 30 Jan 2014 (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.
Rotator cuff tears (injury to the muscle or tendons which stabilise the shoulder) are one of the most common conditions affecting the shoulder. Small and medium sized rotator cuff tears can be managed with arthroscopic or keyhole surgery. Very large or massive tears are difficult to operate on and often have poor rates of healing. As a result surgeons have investigated the use of products to improve the outcome of surgery on massive tears.
The product that the investigators are currently using to try to improve the outcome of surgery for massive rotator cuff tears is called a patch. The patch provides a scaffold to support the muscles of the rotator cuff. Studies of rotator cuff surgery using similar patches have found that recovery is improved and there is a lower rate of postsurgical problems. The aim of this study is to look at whether using the patch improves pain and the clinical function of the shoulder after surgery. In addition, the investigators would like to understand how the patch works. To do this the investigators will scan (take images of) the shoulder using magnetic resonance imaging to look at the muscle damage in the shoulder before and after surgery.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | – | Procedure: Patch |
| Physiotherapy | – | – |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Massive rotator cuff tear patients
Key inclusion criteria (1 listed)
- Ultrasound confirming massive rotator full thickness tear, unacceptable pain and disability following conservative treatment, or previous surgery that has failed, deltoid muscle that is functional, and compliance with post operative rehabilitation.
Key exclusion criteria (15 listed)
- History of infection
- Neurological condition that affects the shoulder girdle
- Presence of rotator cuff arthropathy with stiffness
- Subjects with inability to give informed consent
- Pregnancy or lactation
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 |
|---|---|---|
| Patch | Procedure or surgery | Surgery |
Primary outcome
Change in supraspinatus, infraspinatous and subscapularis water:fat ratio
Time frame: Baseline and 6 months post surgery
Change in supraspinatus, infraspinatous and subscapularis water:fat ratio, assessed by MRI, 6 months postsurgery/ physiotherapy compared to baseline (presurgery/physiotherapy)
3 secondary outcomes
Change in function, pain and patient satisfaction (Oxford Shoulder Score, EQ5D, Constant Score)
Time frame: Baseline and 6 months post surgery
Change in muscle volume (MRI assessment) for the supraspinatus, infraspinatous and subscapularis
Time frame: Baseline and 6 months post-surgery
Change in Goutallier score of muscle atrophy and fatty infiltration (MRI assessment) for the supraspinatus, infraspinatous and subscapularis
Time frame: Baseline and 6 months post-surgery
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 19 Aug 2019.
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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?
An observational study of Massive Rotator Cuff Tears, run by The Leeds Teaching Hospitals 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 1 inclusion and 15 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 19 Aug 2019. 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?
Change in supraspinatus, infraspinatous and subscapularis water:fat ratio (time frame: Baseline and 6 months 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 19 Aug 2019.