Outcome of Balloon Arthroplasty in Irreparable MassiveRotatorCuff Tear
Research type
Research Study
Full title
Outcome of Balloon Arthroplasty in Irreparable, Massive Rotator Cuff Tears
IRAS ID
232426
Contact name
Alison Armstrong
Contact email
Sponsor organisation
University Hospitals of Leicester NHS Trust
Duration of Study in the UK
10 years, 0 months, 29 days
Research summary
Rotator cuff tears are tears in the tendons around the shoulder joint- the rotator cuff. They can occur by injury or occur gradually and may be small or large. They become more common in patients after the age of 50, such that in patients over the age of 70, 30% may have a tear and be unaware of it.
Symptoms vary from those who cannot lift their arm, to those who have a painful range of movement. Symptoms are not always directly related to the size of the tear. It is not known why some patients do not have any symptoms but it is thought this may be due to other muscles around the shoulder taking over the role of the torn tendons.
Although there has been work showing that massive tears can be repaired with augmentation with allograft or muscle transfers, these are not usually used in patients over 65 years old. This is because not only is the retear rate very high but also the muscles behind the ruptured tendon are often atrophic. They never recover after the operation and hence, many people consider that after the age of 70, cuffs should not be repaired.
Although a number of treatment options exist, there is no consensus or definitive guidance on the preferred surgical option to treat this challenging patient population. It is with this background that the Balloon Inspace was developed.It is a biodegradable spacer device implanted for chronic massive irrepairable rotator cuff tear, reducing friction and allowing smooth gliding and enabling leverage of other muscles around the shoulder.It offers patients less pain and a shorter rehabilitation period compared to other options.The spacer in inserted arthroscopically or by a mini incision under general or regional anaesthesia.Our aim is to identify the role of Balloon Arthroplasty with regard to pain relief and functional improvement in patients more than 65 years old with massive irreparable rotator cuff tear.Summary of results
Balloon Arthroplasty” is the term given to inserting a balloon containing saline in the space between the humeral head and the acromion in patients with a massive rotator cuff tear in the shoulder who are too old to consider repair. Its function was believed to be to push down the head and enable a physiotherapy course to occur which would restore function in the shoulder. The balloon in time would burst but the patient would retain movement. It had been successfully used in other units in the UK, however it was the first time in UHL. So a research study was done to recruit 30 patients and follow them up for 5 years. Research questions were was it safe and effective and for how long.
We started the study and were successfully recruiting when a national study started testing Balloon arthroplasty vs extensive debridement but no ballon insertion was started(START-REACTS study). It reported results that showed that both groups significantly improved but those with the balloon had slightly worse outcomes (by 3 points of 48 on the Oxford score). So we felt we should stop recruiting but continue to follow up our patients to 5 years.
7 patients were recruited into the study, 7 male, 3 female. Average age 77(range 74-81).
Within 6 months all patients had significant reduction in pain and scores approaching those of a normal shoulder. 4 patients completed the study, 3 were still doing well at 5 years, I had scores falling away in the last year. 1 died at 4 years and was doing well till disability took over. 2 developed dementia and withdrew.
One patient had a PE a complication of the GA, not the surgery.In conclusion the balloon arthroplasty technique is safe and effective but a national study which compared an extensive debridement(part of the balloon technique) with balloon arthroplasty showed that the balloon was not necessary for a good outcome, just the extensive debridement was good enough. We do not therefore recommend using it for this condition.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
18/EM/0045
Date of REC Opinion
1 May 2018
REC opinion
Further Information Favourable Opinion