The ReShAPE trial: Reverse Shoulder Arthroplasty for treatment of Proximal humeral fractures in the Elderly
Reverse Shoulder Arthroplasty for the treatment of proximal humeral fractures in the elderly – a multicenter combined randomized and observational trial. The ReShAPE Trial
Dr Geoffrey Smith
60 participants
Mar 9, 2016
Interventional
Conditions
Summary
Humeral neck fractures account for 5% of fractures of the appendicular skeleton and are the 3rd commonest osteoporotic fracture occurring with an incidence of 6.6 per 1000 person year. There is a unipolar age distribution with most occurring in the elderly independent population with osteoporosis who fall from a standing height. This incidence is set to increase in the next 20 years as a result of population growth. 49-85% of proximal humeral fractures are minimally displaced and are usually treated non-operatively with most having good outcome regardless of comminution. The poorer outcomes associated with displaced, multi-part fractures has led surgeons to investigate operative alternatives. Studies have not shown a clear benefit from surgical fracture fixation using a variety of implants compared to non-operative treatment because of fracture severity and the difficulty in achieving stable fixation in osteoporotic comminuted (fragmented) bone. Newer fixation devices (locking plates), which have some advantages in osteoporotic bone, have been subject to randomized trials, but have not been shown to improve outcome. Replacement of the fractured humeral head (hemiarthroplasty) is another treatment option, but has not been shown to be clearly superior to non-operative treatment or plate fixation. Recently, reverse total shoulder arthroplasty (replacement) has been used to treat these fractures, with several case series published. This prosthetic design negates the effect of tuberosity malunion and nonunion that are common after internal fixation or hemiarthroplasty by creating a mechanical advantage for the deltoid muscle to allow active forward elevation and abduction. Studies comparing reverse total shoulder arthroplasty to hemiarthroplasty have shown improved pain scores and functional outcomes after reverse shoulder arthroplasty. As a result the use of reverse shoulder arthroplasty for the treatment of proximal humeral fractures is increasing. Reverse shoulder arthroplasty has been reported to have a high complication rate including instability, loosening, poor rotation and radiological notching. The risk of complications and prosthetic longevity limits the use of reverse shoulder arthroplasty in young patients with most prostheses being inserted in patients over 65. No comparative trial has been performed to test the effectiveness of reverse total shoulder arthroplasty against non-operative treatment.
Eligibility
Inclusion Criteria7
- or 4 part proximal humerus fracture according to the Neer classification
- Medically fit for surgery
- Patient 70 years of age or older
- Presentation within 28 days after injury
- Independent living (including hostel accommodation)
- Isolated injury
- Available for follow up for 24 months
Exclusion Criteria10
- Inability to consent (limited cognitive capacity judged by 3 or more errors on the mini- mental status examination 6 item screener or limited English proficiency)
- Pre-existing injury or condition of the affected side which severely affected the movement of the shoulder (eg CVA, pre-existing shoulder pathology, previous fracture or surgery)
- Pathological fracture
- Other injury to the same upper limb requiring surgery
- Open fracture
- Fracture-dislocation or head splitting fracture
- Glenoid fracture
- Axillary nerve palsy
- Gross fracture displacement – no bony contact between humeral shaft and articular segment
- Medical condition precluding anaesthetic
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Interventions
Participants randomised to surgery will be treated by insertion of a reverse total shoulder arthroplasty within 28 days of the date of injury. This procedure usually takes 2 hours to perform. Surgical technique (approach, version, component fixation and prosthesis choice) will be left to the discretion of the treating consultant orthopaedic surgeon. The glenosphere will be placed low, avoiding superior tilt. The tuberosities will be repaired using nonabsorbable sutures. The arm will be placed in a shoulder immobilizer (either in internal rotation or some external rotation at the discretion of the treating surgeon). Post operatively patients will be instructed on elbow wrist and hand exercises to commence immediately. After two weeks pendular exercises and passive flexion to 90 and passive external rotation to neutral will be commenced. Unrestricted passive, active assisted exercises will be allowed, graduating to active mobilisation (as tolerated) at 6 weeks. Resisted range of motion exercises will be allowed after 12 weeks. A minimum of 5 physiotherapy one on one face to face contacts within 3 months of treatment will be required. Patients will perform self-guided exercises every day as instructed in their face-to-face sessions. The exact duration, timing and structure of the physiotherapy sessions is not specified. The design of the trial reflects the heterogeneity of rehabilitation practices in common usage. Patients who do not consent to be randomised will be offered participation in the observational arm of the study. Their treatment will consist the same two treatment options as the RCT arm. Treatment will be decided by patient preference as per usual practice at each institution. Treatment protocols, follow up and outcome measures will be the same as the randomised arm. The outcome of this arm of the trial will be analysed separately. The physiotherapy regime in the observational arm of the study is identical to that of the randomised trial.
Locations(11)
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ACTRN12616000345482