Efficacy and safety of the InSpace device in rotator cuff repairs.
Research type
Research Study
Full title
A randomised, two-arm, prospective, subject blind study to assess the efficacy and safety of InSpace device in comparison to massive rotator cuff repair in subjects scheduled for a repair surgery.
IRAS ID
122315
Contact name
Lennard Funk
Sponsor organisation
OrthoSpace Ltd
Research summary
This is a post marketing study to further assess the safety and effectiveness of the use of the InSpace biodegradeable balloon in the surgical repair of large rotator cuff tears as compared with surgery alone. The rotator cuff is a complex network of muscles and tendons that hold the shoulder in place and enable the arm to rotate. The space between the rotator cuff and the upper bone of the shoulder (the Acromion) is filled with a fluid sac called the bursa. The InSpaceTM balloon, implanted using a simple 10-minute procedure during shoulder surgery, is designed to replicate the action of the bursa during the healing process. It removes friction, and correctly spaces the tendons and muscles in the rotator cuff which in turn promotes more successful rehabilitation. Patients with radiologically confirmed full-thickness tears will be approached to take part in the study. On acceptance they will be randomised to either the control arm(surgical intervention alone)or to the study arm (surgical intervention plus placement of the balloon. The effectiveness will be assessed using outcome questionnaires with respect to pain reduction and improvement of activity of daily living throughout the rehabilitation period. Participants will also be asked to attend post-operative follow-up clinic visits so that a therapist can assess improvement in range of motion. A MRI scan will be taken at 12 months post-op in order to assess the clinical outcome.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
13/NW/0754
Date of REC Opinion
16 Jan 2014
REC opinion
Further Information Favourable Opinion