RecruitingACTRN12616000345482

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


Sponsor

Dr Geoffrey Smith

Enrollment

60 participants

Start Date

Mar 9, 2016

Study Type

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

Sex: Both males and femalesMin Age: 70 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares two treatments for a type of complex shoulder fracture (3- or 4-part proximal humerus fracture) in older adults: surgery to replace the broken shoulder joint with a reverse total shoulder prosthesis, versus non-surgical treatment (wearing a sling and rehabilitation). These fractures are common in elderly people who fall, and there is currently no strong evidence about whether surgery is better than non-surgical care. Participants are followed for two years. You may be eligible if: - You are 70 years of age or older - You have a 3 or 4-part shoulder fracture (as classified by your surgeon) - You are medically well enough for surgery - The fracture happened within the past 28 days - You live independently (including hostel accommodation) - You have no other major injuries - You are able to return for follow-up over 2 years You may NOT be eligible if: - You have cognitive difficulties or limited English that prevents you from giving informed consent - You have a pre-existing condition on the affected side severely limiting shoulder movement (e.g. stroke, previous surgery) - The fracture was caused by cancer - You have other injuries on the same arm needing surgery - The fracture is open, involves the socket, or has split the head of the bone - You have nerve damage to the arm (axillary nerve palsy) Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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

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)

St George Hospital - Kogarah

ACT,NSW, Australia

The Sutherland Hospital - Caringbah

ACT,NSW, Australia

Prince of Wales Hospital - Randwick

ACT,NSW, Australia

Royal Prince Alfred Hospital - Camperdown

ACT,NSW, Australia

Westmead Hospital - Westmead

ACT,NSW, Australia

Concord Repatriation Hospital - Concord

ACT,NSW, Australia

Royal North Shore Hospital - St Leonards

ACT,NSW, Australia

Gosford Hospital - Gosford

ACT,NSW, Australia

John Hunter Hospital Royal Newcastle Centre - New Lambton

ACT,NSW, Australia

Liverpool Hospital - Liverpool

ACT,NSW, Australia

The Canberra Hospital - Garran

ACT,NSW, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12616000345482


Related Trials