The ReShAPE trial: Reverse Shoulder Arthroplasty for treatment of Proximal humeral fractures in the Elderly

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616000345482
• Date of registration: 16/03/2016
• Prospective Registration: No
• Primary sponsor: Dr Geoffrey Smith
• Public title: The ReShAPE trial: Reverse Shoulder Arthroplasty for treatment of Proximal humeral fractures in the Elderly
• Scientific title: Reverse Shoulder Arthroplasty for the treatment of proximal humeral fractures in the elderly – a multicenter combined randomized and observational trial. The ReShAPE Trial
• Date of first enrolment: 09/03/2016
• Target sample size: 60
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12616000345482.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Geoffrey Smith

• Name: Dr Geoffrey Smith

Key inclusion & exclusion criteria

Inclusion criteria: 3 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 criteria: 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


Age minimum: 70 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Proximal Humeral Fractures;
Proximal Humeral Fractures

Injuries and Accidents - Fractures

Surgery - Surgical techniques

Intervention(s)

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 ra

Primary Outcome(s)

ASES (American Shoulder and Elbow Society) Standardised Shoulder Assessment score patient self-report section.
This scoring system consists of two dimensions: pain and activities of daily living, which are both equally weighted giving a total score out of 100. It has been show to be reliable, valid and responsive across a number of shoulder pathologies
[ASES score will be measured at 3 months 6 months 1, 2, 5 and 10 years. ]

Secondary Outcome(s)

Complications after reverse shoulder arthroplasty (repeat shoulder surgery, readmission, infection requiring treatment, neurological deficit, dislocation, death). These events will be reported to the coordinating centre by the local investigators. At the conclusion of the study this data will be checked using medical records.[3 months, 6 months, 1, 2, 5 and 10 years]

DASH (Disability of the Arm, Shoulder and Hand)




[3 months 6 months 1, 2, 5 and 10 years. ]

Pain (verbal analogue scale 0-10 points)[3 months 6 months 1, 2, 5 and 10 years. ]

EQ-5D and EQ VAS (Quality of life and general health)[3 months 6 months 1, 2, 5 and 10 years. ]

Radiological parameters:
1) healing of the tuberosities (non-union or resorption will be considered failures to heal),
2) position of the tuberosities
3) scapula notching (according to the Sirveaux classification system)
4) prosthetic loosening
5) alignment (coronal and sagittal plane for patients treated non-operatively)

All radiographs will be assessed by two independent observers independently. In case of discrepancy the scoring will be decided by joint assessment.[3 months 6 months 1, 2, 5 and 10 years. ]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

St George Hospital Orthopaedic Department

Ethics review

Status: Approved
Approval date:
Contact:

ACT Health Human Research Ethics Committee

Status: Approved
Approval date:
Contact:

South Eastern Sydney Local Health District Human Research Ethics Committee