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SPARC: Shoulder PAtch for Rotator Cuff Tears

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ClinicalTrials.gov Identifier: NCT02049684
Recruitment Status : Unknown
Verified September 2014 by The Leeds Teaching Hospitals NHS Trust.
Recruitment status was:  Recruiting
First Posted : January 30, 2014
Last Update Posted : September 25, 2014
Sponsor:
Information provided by (Responsible Party):
The Leeds Teaching Hospitals NHS Trust

Brief 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. 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.


Condition or disease Intervention/treatment
Massive Rotator Cuff Tears Procedure: Patch

Study Type : Observational
Time Perspective: Prospective
Official Title: SPARC: Shoulder PAtch for Rotator Cuff Tears
Study Start Date : January 2013
Estimated Primary Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Group/Cohort Intervention/treatment
Surgery Procedure: Patch
Physiotherapy



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Change in function, pain and patient satisfaction (Oxford Shoulder Score, EQ5D, Constant Score) [ Time Frame: Baseline and 6 months post surgery ]
    Change in function, pain and patient satisfaction (Oxford Shoulder Score, EQ5D, Constant Score)

  2. Change in muscle volume (MRI assessment) for the supraspinatus, infraspinatous and subscapularis [ Time Frame: Baseline and 6 months post-surgery ]
    Change in muscle volume (MRI assessment) for the supraspinatus, infraspinatous and subscapularis

  3. 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 ]
    Change in Goutallier score of muscle atrophy and fatty infiltration (MRI assessment) for the supraspinatus, infraspinatous and subscapularis



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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Massive rotator cuff tear patients
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02049684


Contacts
Contact: Roger Hackney, FRCS 0113 392 4779 roger.hackney@leedsth.nhs.uk

Locations
United Kingdom
Leeds Teaching Hospital NHS Trust Recruiting
Leeds, United Kingdom, LS7 4SA
Contact: Roger Hackney, FRCS         
Sponsors and Collaborators
The Leeds Teaching Hospitals NHS Trust

Responsible Party: The Leeds Teaching Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02049684     History of Changes
Other Study ID Numbers: OR11/10063
13/YH/0030 ( Other Identifier: Research Ethics Committee )
First Posted: January 30, 2014    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries