Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000232437
Ethics application status
Not required
Date submitted
14/02/2016
Date registered
19/02/2016
Date last updated
27/11/2018
Date data sharing statement initially provided
27/11/2018
Date results information initially provided
27/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Medium-term clinical and radiographic outcome of DePuy Delta Xtend reverse shoulder replacement at a minimum 5 year follow-up
Scientific title
Medium-term clinical and radiographic outcome of DePuy Delta Xtend reverse TSA at a minimum 5 year follow-up
Secondary ID [1] 288532 0
Nil known
Universal Trial Number (UTN)
Nil known
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
shoulder arthritis associated with rotator cuff tear 297630 0
post traumatic shoulder arthritis with rotator cuff tear 297678 0
massive irreparable rotator cuff tear with or without arthritis 297679 0
Condition category
Condition code
Musculoskeletal 297820 297820 0 0
Osteoarthritis
Musculoskeletal 297855 297855 0 0
Other muscular and skeletal disorders
Surgery 297856 297856 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Clinical (objective and patient derived) outcome analysis at a minimum of 5 years post-op following implantation of Delta Xtend reverse TSA - one clinical assessment and completion of patient questionnaires. Approximate duration of assessment 1.5 hours.
Standardised radiographic analysis of Delta Xtend reverse TSA at a minimum of 5 years follow-up to assess for the presence of recognised complications associated with the use of reverse TSA. No maximium duration since surgery. All patients will fall between 5 and 8 years post-op.
Analysis of patient outcome and relationship to radiographic findings.
Analysis of patient outcome and radiographic findings to pre-op diagnosis.
Survivorship analysis looking at re-operation and revision rates.
Intervention code [1] 293908 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297345 0
Clinical (objective examination and patient derived outcome from questionnaires) outcome analysis at a minimum of 5 years post-op following implantation of Delta Xtend reverse TSA.
Patient questionnaires include ASES Score, DASH, Oxford Score, and SF-12. All have been validated.
Timepoint [1] 297345 0
minimum 5 years post-op. No maximum duration.
Primary outcome [2] 297381 0
Standardised radiographic analysis of Delta Xtend reverse TSA at a minimum of 5 years
Timepoint [2] 297381 0
minimum 5 years post-op. No maximum duration.
Primary outcome [3] 297382 0
Analysis to assess for the presence of recognised complications associated with the use of reverse TSA - these include dislocation, fracture, nerve injury, infection, loosening, notching, and ongoing pain. All patients have continued to be followed-up by primary investigator and all complications and re-operations to date have already been recorded.
Timepoint [3] 297382 0
minimum 5 years post-op. No maximum duration.
Secondary outcome [1] 320768 0
Analysis of patient outcome and relationship to radiographic findings. Assessment will include clinical assessment including range of motion and strength, patient derived outcomes including ASES Score, DASH, Oxford Score, and SF-12, and standard radiographic views including joint space AP and axillary lateral.
This is a composite secondary outcome.
Range of motion will be assessed using a standard goniometer; strength will be assessed using an isokinetic dynamometer (flexion and external rotation).
Timepoint [1] 320768 0
Minimum 5 year follow-up. No maximum duration.
Secondary outcome [2] 320886 0
Analysis of patient outcome and radiographic findings to pre-op diagnosis. Clinical assessment including range of motion and strength. Patient derived outcomes including ASES Score, DASH, Oxford Score, and SF-12. Standard radiographic views including joint space AP and axillary lateral.
This is a composite secondary outcome.
Timepoint [2] 320886 0
Minimum 5 year follow-up. No maximum duration.
Secondary outcome [3] 320887 0
Survivorship analysis looking at re-operation and revision rates. Statistical analysis using University of Auckland statistician. Re-operation and revision rates will be determined and overall survivorship at 5 years determined. Kaplan-Meir analysis to determine long-term survivorship. Routine statistical analysis.
Timepoint [3] 320887 0
Minimum 5 year follow-up. No maximum duration.

Eligibility
Key inclusion criteria
Retrospective analysis of a consecutive series of prospectively enrolled patients following reverse TSA for a variety of indications using the DePuy Delta Xtend reverse RSA system.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients excuded if surgery not carried out by pre-designated surgeon, if a conventional TSA or other form of arthroplasty rather than a reverse TSA was performed, or if an alternative implant was used for the procedure.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Primary focus will be on patient and radiographic analysis at a minimum of 5 years follow-up period as an assessment of medium term outcome of this implant. Patient outcome will be determined by objective examinaion criteria including range of motion and strength assessment. Radiographic analysis performed utilising standardised AP and axillary lateral projections to assess for evidence of complications and early loosening. Statistical analysis will be performed by University of Auckland statistician looking for specific associations. Results will be compared to previously published literature of other similar implants.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
27/06/2007
Date of last participant enrolment
Anticipated
Actual
20/11/2013
Date of last data collection
Anticipated
Actual
22/12/2017
Sample size
Target
80
Accrual to date
Final
68
Recruitment outside Australia
Country [1] 7589 0
New Zealand
State/province [1] 7589 0
Auckland

Funding & Sponsors
Funding source category [1] 292882 0
Commercial sector/Industry
Name [1] 292882 0
DePuy International Ltd
Country [1] 292882 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
DePuy International Ltd
Address
St. Anthony's Road,
Leeds,
LS11 8DT
UK
Country
United Kingdom
Secondary sponsor category [1] 291626 0
None
Name [1] 291626 0
Nil
Address [1] 291626 0
Nil
Country [1] 291626 0
Other collaborator category [1] 278825 0
Individual
Name [1] 278825 0
Craig M Ball
Address [1] 278825 0
Auckland Bone and Joint Surgery
Private Bag 28912
Remuera
Auckland 1541
Country [1] 278825 0
New Zealand

Ethics approval
Ethics application status
Not required

Summary
Brief summary
TSA is now well established as a means to relieve pain and improve function for a variety of shoulder arthritic conditions. Reverse TSA use has increased, with most joint registries showing that at least 50% of arthroplasty procedures performed involve use of the reverse TSA. Concerns remain however regarding complication and failure rates with reverse TSA, with little medium and no long term outcomes reported in the literature. Many different reverse TSA designs are now in use, including 155 degree neck shaft angle Grammont designs, to designs that utilise either 145 degree or even 135 degree neck shaft angles. Short stem designs are now available, in addition to designs that lateralise the centre of rotation or lateralise the humeral shaft. At present we do not know what the optimal reverse configuration is, and only medium and long term follow-up studies that look specifically at implant design can help answer this question. Longer term outcomes following reverse TSA remains poorly defined, and very little literature is available on newer implant designs.
The primary purpose of this study is to critically look at both clinical (patient) and radiographic (Xray) outcomes of the DePuy Delta Xtend reverse TSA. This will to add to the body of literature regarding reverse TSA and specifically to our understanding of this implant and the indications for its use.
Trial website
Trial related presentations / publications
Public notes
Ethical approval applied for to Health and Disability Ethics Committee. They determined that study did not require formal submission to HDEC as it was not within the scope of a HDEC review.

Contacts
Principal investigator
Name 63522 0
Dr Craig M Ball
Address 63522 0
Auckland Bone and Joint Surgery
Private Bag 28912,
Remuera,
Auckland 1541
Country 63522 0
New Zealand
Phone 63522 0
+6495209631
Fax 63522 0
+6495209636
Email 63522 0
[email protected]
Contact person for public queries
Name 63523 0
Dr Craig M Ball
Address 63523 0
Auckland Bone and Joint Surgery
Private Bag 28912,
Remuera,
Auckland 1541
Country 63523 0
New Zealand
Phone 63523 0
+6495209631
Fax 63523 0
+6495209636
Email 63523 0
[email protected]
Contact person for scientific queries
Name 63524 0
Dr Craig M Ball
Address 63524 0
Auckland Bone and Joint Surgery
Private Bag 28912,
Remuera,
Auckland 1541
Country 63524 0
New Zealand
Phone 63524 0
+6495209631
Fax 63524 0
+6495209636
Email 63524 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All data deidentified


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Submitted for publication in "Shoulder and Elbow" ... [More Details]

Documents added automatically
No additional documents have been identified.