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Trial registered on ANZCTR


Registration number
ACTRN12616000345482
Ethics application status
Approved
Date submitted
10/03/2016
Date registered
16/03/2016
Date last updated
22/02/2017
Type of registration
Retrospectively registered

Titles & IDs
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
Secondary ID [1] 288712 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ReShAPE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Proximal Humeral Fractures 297941 0
Condition category
Condition code
Injuries and Accidents 298105 298105 0 0
Fractures
Surgery 298139 298139 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 294144 0
Treatment: Surgery
Comparator / control treatment
Patients will be placed in a shoulder immobilizer. Elbow wrist and hand exercises will be allowed immeadiately. After 2 weeks pendular exercises and passive flexion to 90 and passive external rotation to neutral will be commenced. Unrestricted passive, active assisted will be allowed graduating to active mobilization (as tolerated) at 6 weeks. Resisted range of motion exercises will be allowed after 12 weeks. A minimum of 5 physiotherapy contacts within 3 months of treatment will be required.
Control group
Active

Outcomes
Primary outcome [1] 297616 0
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
Timepoint [1] 297616 0
ASES score will be measured at 3 months 6 months 1, 2, 5 and 10 years.
Secondary outcome [1] 321595 0
DASH (Disability of the Arm, Shoulder and Hand)




Timepoint [1] 321595 0
3 months 6 months 1, 2, 5 and 10 years.
Secondary outcome [2] 321686 0
EQ-5D and EQ VAS (Quality of life and general health)
Timepoint [2] 321686 0
3 months 6 months 1, 2, 5 and 10 years.
Secondary outcome [3] 321687 0
Pain (verbal analogue scale 0-10 points)
Timepoint [3] 321687 0
3 months 6 months 1, 2, 5 and 10 years.
Secondary outcome [4] 321688 0
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.
Timepoint [4] 321688 0
3 months 6 months 1, 2, 5 and 10 years.
Secondary outcome [5] 321689 0
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.
Timepoint [5] 321689 0
3 months, 6 months, 1, 2, 5 and 10 years

Eligibility
Key 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
Minimum age
70 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic (adaptive) random allocation stratified by site using minimisation to allow for gender and age (70-80, over 80).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
The study will be a combined a randomized and observational study
The core study will be a multi-centre prospective randomised controlled trial.
Patients who do not consent to be randomised will be offered participation in the observational arm of the study. The outcome of this arm of the trial will be analysed separately. The use of an observational ‘preference’ arm in addition to the core RCT addresses criticisms of selection bias in the RCT by following non-randomised patients, and increases generalisability by following a large cohort of patients receiving the same treatment options as the RCT, as part of usual care.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample Size calculation
Case series documenting the outcome after reverse shoulder arthroplasty have shown a standard deviation (SD) of 13 in the ASES score. The minimum important clinical difference (MICD) in ASES scores has been estimated to be 6.4-18. We consider a difference of 10 to be necessary in order to justify the additional costs and risks of surgery. A total of 60 patients (30 in each group) will provide 80% power to detect a MICD of 10 points at significance of 0.5%. We aim to recruit 72 patients to allow for 20% loss to follow-up.

Statistical analysis
Differences in baseline characteristics (i.e., intrinsic and injury-related variables) between both intervention groups will be assessed using the student’ s t-test (parametric continuous data), Mann-Whitney U-test (nonparametric continuous data) or Chi-square test (categorical data).
Unadjusted analysis by intention-to-treat will be performed to test the difference in primary and secondary outcomes between the intervention groups. Student’ s t-test (parametric continuous data), Mann Whitney U-test (nonparametric continuous data) or Chi-square analysis (categorical data) will be used. A p-value < 0.05 (2-sided tests) will be taken as threshold of statistical significance.
The observational arm will be analysed separately, comparing the same treatment groups against the same outcomes using multivariable linear regression to adjust for potential confounders


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW
Recruitment hospital [1] 5400 0
St George Hospital - Kogarah
Recruitment hospital [2] 5401 0
The Sutherland Hospital - Caringbah
Recruitment hospital [3] 5403 0
Prince of Wales Hospital - Randwick
Recruitment hospital [4] 5404 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [5] 5405 0
Westmead Hospital - Westmead
Recruitment hospital [6] 5406 0
Concord Repatriation Hospital - Concord
Recruitment hospital [7] 5407 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [8] 5408 0
Gosford Hospital - Gosford
Recruitment hospital [9] 5409 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment hospital [10] 5410 0
Liverpool Hospital - Liverpool
Recruitment hospital [11] 5411 0
The Canberra Hospital - Garran

Funding & Sponsors
Funding source category [1] 293070 0
Hospital
Name [1] 293070 0
St George Hospital Orthopaedic Department
Address [1] 293070 0
Gray Street,
Kogarah
NSW 2217
Country [1] 293070 0
Australia
Primary sponsor type
Individual
Name
Dr Geoffrey Smith
Address
Sydney Orthopaedic Trauma and Reconstructive Surgery
5/19 Kensington Street
Kogarah
NSW 2217

Affiliation
St George Hospital, Sydney, Australia
Country
Australia
Secondary sponsor category [1] 291851 0
None
Name [1] 291851 0
Address [1] 291851 0
Country [1] 291851 0
Other collaborator category [1] 278870 0
Individual
Name [1] 278870 0
Dr Ed Bateman
Address [1] 278870 0
Gosford Private Hospital, Burabil Av, Gosford North. NSW 2250

Affiliation: Gosford Hospital, Australia
Country [1] 278870 0
Australia
Other collaborator category [2] 278871 0
Individual
Name [2] 278871 0
Dr Ben Cass
Address [2] 278871 0
201 / 156 Pacific Highway, St Leonards NSW 2065

Affiliation: Royal North Shore Hospital, Sydney, Australia
Country [2] 278871 0
Australia
Other collaborator category [3] 278872 0
Individual
Name [3] 278872 0
Dr Maurizio Damiani
Address [3] 278872 0
51 Jardine St, Kingston ACT 2604

Affiliation: The Canberra Hospital, Canberra, Australia
Country [3] 278872 0
Australia
Other collaborator category [4] 278873 0
Individual
Name [4] 278873 0
Dr Wade Harper
Address [4] 278873 0
11/ Level 7 Prince of Wales Private Hospital, Barker Street, Randwick. NSW 2301

Affiliation: The Prince of Wales Hospital, Sydney, Australia
Country [4] 278873 0
Australia
Other collaborator category [5] 278874 0
Individual
Name [5] 278874 0
Prof Ian Harris
Address [5] 278874 0
78/23-27 MacMahon Street, Hurstville NSW 2220

Allifilation: Liverpool Hospital, Sydney, Australia
Country [5] 278874 0
Australia
Other collaborator category [6] 278875 0
Individual
Name [6] 278875 0
Dr David Lieu
Address [6] 278875 0
Dept of Orthopaedic Surgery, Locked Bag 7103, Liverpool, NSW 2170

Allifilation: Liverpool Hospital, Sydney, Australia
Country [6] 278875 0
Australia
Other collaborator category [7] 278876 0
Individual
Name [7] 278876 0
Dr Minas Petrelis
Address [7] 278876 0
52 Smith St, Charlestown, NSW 2290

Affiliation: John Hunter Hospital, Australia
Country [7] 278876 0
Australia
Other collaborator category [8] 278877 0
Individual
Name [8] 278877 0
Dr Kalman Piper
Address [8] 278877 0
303/2 Technology Place, Macquarie University, NSW 2109

Affiliation: Westmead Hospital, Australia
Country [8] 278877 0
Australia
Other collaborator category [9] 278878 0
Individual
Name [9] 278878 0
Dr Chris Smithers
Address [9] 278878 0
101/100 Carillon Avenue, Newtown, NSW 2042

Affiliation: Royal Prince Alfred Hospital, Australia
Country [9] 278878 0
Australia
Other collaborator category [10] 278879 0
Individual
Name [10] 278879 0
Dr John Trantalis
Address [10] 278879 0
8 Australia Av, Sydney Olympic Park, NSW 2127

Affiliation: Concord Hospital, Australia
Country [10] 278879 0
Australia
Other collaborator category [11] 278880 0
Individual
Name [11] 278880 0
Dr Hugh Jones
Address [11] 278880 0
Suite3L4, St George Private Hospital, 1 SouthSt, Kogarah, NSW

Affiliation: St George Hospital, Sydney, Australia
Country [11] 278880 0
Australia
Other collaborator category [12] 278881 0
Individual
Name [12] 278881 0
Dr Jeff Petchell
Address [12] 278881 0
Suite 2 155 Missenden Rd, Newtown, NSW 2042

affiliation: Royal Prince Alfred Hospital, Australia
Country [12] 278881 0
Australia
Other collaborator category [13] 278882 0
Individual
Name [13] 278882 0
Dr Doron Sher
Address [13] 278882 0
160 Belmore Road, Randwick, NSW 2031

Affiliation: Concord Hospital, Sydney, Australia
Country [13] 278882 0
Australia
Other collaborator category [14] 278883 0
Individual
Name [14] 278883 0
Prof David Sonnabend
Address [14] 278883 0
201/156 Pacific Highway, St Leonards, NSW 2065

Affiliation: Royal North Shore Hospital, Australia
Country [14] 278883 0
Australia
Other collaborator category [15] 278884 0
Individual
Name [15] 278884 0
Dr Sindy Vrancic
Address [15] 278884 0
Suite 11, NCPH, Garran, ACT 2604

Affiliation: The Canberra Hospital, Australia
Country [15] 278884 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294587 0
South Eastern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 294587 0
Room G71 East Wing
Edmund Blacket Building
Prince of Wales Hospital
Barker Street,
RANDWICK NSW 2031
Ethics committee country [1] 294587 0
Australia
Date submitted for ethics approval [1] 294587 0
25/02/2015
Approval date [1] 294587 0
20/08/2015
Ethics approval number [1] 294587 0
HREC/15/POWH/98
Ethics committee name [2] 294588 0
ACT Health Human Research Ethics Committee
Ethics committee address [2] 294588 0
Building 10, Level 6, Canberra Hospital, PO Box 11, Woden ACT 2606
Ethics committee country [2] 294588 0
Australia
Date submitted for ethics approval [2] 294588 0
04/08/2015
Approval date [2] 294588 0
06/11/2015
Ethics approval number [2] 294588 0
ETH.8.15.152

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64222 0
Dr Geoffrey Smith
Address 64222 0
Sydney Orthopaedic Trauma and Reconstructive Surgery
5/19 Kensington St.,
Kogarah. NSW 2217

Affiliation: St George and Sutherland Hospitals, Sydney, Australia
Country 64222 0
Australia
Phone 64222 0
+61 2 95874720
Fax 64222 0
+61 2 95876927
Email 64222 0
gcssmith@icloud.com
Contact person for public queries
Name 64223 0
Dr Geoffrey Smith
Address 64223 0
Sydney Orthopaedic Trauma and Reconstructive Surgery
5/19 Kensington St.,
Kogarah. NSW 2217

Affiliation: St George and Sutherland Hospitals, Sydney, Australia
Country 64223 0
Australia
Phone 64223 0
+61 2 95874720
Fax 64223 0
+61 2 95876927
Email 64223 0
gcssmith@icloud.com
Contact person for scientific queries
Name 64224 0
Dr Geoffrey Smith
Address 64224 0
Sydney Orthopaedic Trauma and Reconstructive Surgery
5/19 Kensington St.,
Kogarah. NSW 2217

Affiliation: St George and Sutherland Hospitals, Sydney, Australia
Country 64224 0
Australia
Phone 64224 0
+61 2 95874720
Fax 64224 0
+61 2 95876927
Email 64224 0
gcssmith@icloud.com

No information has been provided regarding IPD availability
Summary results
No Results