InSpace Balloon or Repair for Massive Rotator Cuff Tears - Randomised Control Study (UK)
InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tears.
Registered with National Institutes of Health Clinical Trials Protocol Registration System in (IRAS ID 122315). ClinicalTrials.gov Identifier: NCT02208440
The Study is conducted by Upper Limb Unit, Wrightington, Wigan & Leigh NHS Foundation Trust, Wrightington Hospital, UK
Background:
Rotator cuff tears (RCTs) are among the most common tendon injuries seen in orthopedic patients, resulting in significant pain and disability. The incidence of rotator cuff tears increases in frequency with age and is often associated with degeneration of the tendons. Full thickness tears of the rotator cuff are among the most common sources of pain and dysfunction in the shoulder.
A range of surgical options are available including debridement, with or without partial tendon repair, tendon transfer, muscle-tendon slide procedures, the utilization of rotator cuff allografts and synthetic graft materials, arthrodesis and arthroplasty, reverse arthroplasty, or hemiarthroplasty.
The tear repair, allows reduction of pain, improvement in shoulder kinematics and rehabilitation.
The InSpace™ device is a biodegradable, balloon-shaped spacer that is deployed arthroscopically into the subacromial space of the shoulder, acting as a spacer in patients with massive rotator cuff tears.
Aims:
The aim of this two-arm , randomized controlled post-marketing clinical trial is to further assess the safety and efficacy of the treatment of InSpace™ device (biodegradable sub-acromial implantable spacer) in comparison to rotator cuff best repair in patients diagnosed with Full-Thickness Massive Rotator Cuff tear who scheduled for a Repair surgery.
Study Design:
The study started in July 2014 and the plan is to recruit 40 participants (20 at each treatment arm).
Patients with positive diagnostic imaging (by MRI) confirming full thickness Massive RCT (of at least 5 cm involving more than one tendon), who has persistent pain of the affected shoulder for at least 3 months (with no response to conservative treatment), scheduled to surgical repair of the tear and eligible per study criteria, will be randomly allocated (using a masked allocation procedure) to either rotator cuff repair or arthroscopic implantation of the InSpaceTM device.
All participants will then be followed and evaluated for clinical outcome (pain, shoulder function, activity of daily living and quality of life) 3-6 weeks, 3,6,12 and 24 months post randomization. Participants (but not surgeons) will be blind to whether repair surgery or InSpace™ device implantation was performed.
Data analysis will be conducted on an intention-to-treat basis.
How can you help?
Clinicians - we are trying to recruit as many patients as possible. If you feel you have a suitable patient and are based in the UK, please refer the patient to Wrightington Hospital in the North.
Patients - If you have been diagnosed with Massive Rotator Cuff Tear that requires surgical repair and would like to participate in the study, please discuss with your doctor or contact us.
Contact Details:
Wrightington - ann.birch@wwl.nhs.uk
