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OpenTrials
Completed

NCT Number: NCT02049684

SPARC: Shoulder PAtch for Rotator Cuff Tears

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.

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Key information

Conditions

Massive Rotator Cuff Tears

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Leeds Teaching Hospital NHS Trust

Leeds, LS7 4SA, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patch

Procedure

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The Leeds Teaching Hospitals NHS Trust

Other

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jan 30, 2014
Registry last updated
Aug 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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