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Trial registered on ANZCTR


Registration number
ACTRN12613001183774
Ethics application status
Approved
Date submitted
8/10/2013
Date registered
29/10/2013
Date last updated
21/05/2024
Date data sharing statement initially provided
27/11/2018
Date results information initially provided
28/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of the Mathys Affinis Short Stem Total Shoulder Replacement on medium to long term pain and functional outcomes in patients with shoulder arthritis
Scientific title
The effect of the Mathys Affinis Short Stem Total Shoulder Replacement on medium to long term pain and functional outcomes in patients with shoulder arthritis
Secondary ID [1] 283368 0
Nil
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder Arthritis 290272 0
Condition category
Condition code
Musculoskeletal 290661 290661 0 0
Osteoarthritis
Inflammatory and Immune System 290681 290681 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All suitable patients with arthritis of the glenohumeral joint causing marked decrease in quality of life were operated on and had the Affinis Short stem prosthesis implanted.
The Affinis Short Stem glenoid component is double pegged, curved back polyethylene. The stem is titanium with bioactive calcium phosphate coating and on growth surface. The surgical procedure takes about 2 hours.
A change in the material used in the glenoid component liner from polyethylene to Vitamin E enhanced cross linked polyethylene, included a cohort of a further 110 patients.
Intervention code [1] 288098 0
Treatment: Surgery
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290681 0
Reduction in pain compared with pre-operation. Self assessed on a VAS of 0= no pain to 10= worst pain imaginable.
Timepoint [1] 290681 0
2 weeks, 6-8 weeks and annually for 2 years
Primary outcome [2] 290682 0
Evaluation of validated shoulder scores, ASES, SPADI, ASES and Constant compared with pre-operation.
Timepoint [2] 290682 0
6 weeks and annually for two years
Primary outcome [3] 290699 0
Assessment of radioluncency around the glenoid and stem. Plain X-ray with 3 views. 1. True AP Glenoid with forearm in 20 degrees of external rotation. 2. Axillary view 3. Scapular lateral
Timepoint [3] 290699 0
6 weeks and annually thereafter for 15 to 20 years until radiolucent lines indicate prosthesis failure.
Secondary outcome [1] 305025 0
Patient satisfaction with surgical outcome.
Timepoint [1] 305025 0
Annually self scored as 0% 25%, 50%, 75% or 100% and annually thereafter as routine follow up for 15 to 20 years until prosthesis failure.

Eligibility
Key inclusion criteria
Age 35- 80 years. Booked for a total shoulder replacement. The following concurrent diagnoses are not an exclusion: Osteoarthritis, AVN, Cuff tear Full thickness supraspinatus<1cm with centralised head, Clinical diagnosis of osteoporosis<2SD,Post instability arthritis, post capsulorrhaphy.
Minimum age
35 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Rotator cuff tears not included in inclusion criteria, Clinical diagnosis of osteoporosis >2SD, post traumatic osteo-arthritis, abnormal neurology, mental inability to comply with rehabilitation, mental inability to comply with study requirements.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients presenting with shoulder disease requiring a total shoulder replacement will have pre and post operative care routine care. If the Mathys Affinis Short Stem prosthesis is the most suitable prosthesis for their disease, they will be invited to enrol in the outcome study in which they agree to complete the additional post operative validated shoulder outcome scores.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not randomised
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Consecutive patients.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A statistician from the Department of Mathematics, University of Melbourne calculated that 80 patients were required for 80% power to assess failure at 2 years defined as the need to revise the prosthesis.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
22/04/2012
Actual
22/04/2012
Date of last participant enrolment
Anticipated
22/04/2014
Actual
22/04/2014
Date of last data collection
Anticipated
30/04/2028
Actual
Sample size
Target
80
Accrual to date
Final
190
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 288102 0
Commercial sector/Industry
Name [1] 288102 0
Mathys Limited Bettlach,Mathys Orthopaedics Pty Ltd
Country [1] 288102 0
Australia
Primary sponsor type
Individual
Name
A/Professor Simon Bell
Address
Melbourne Shoulder and Elbow Centre
31 Normanby St., Vic. Brighton 3186
Country
Australia
Secondary sponsor category [1] 286822 0
None
Name [1] 286822 0
Address [1] 286822 0
Country [1] 286822 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290025 0
Monash University Human Research Ethics
Ethics committee address [1] 290025 0
Building 3E, Room 111,Clayton Campus, Wellington Road, Clayton Vic 3168
Ethics committee country [1] 290025 0
Australia
Date submitted for ethics approval [1] 290025 0
Approval date [1] 290025 0
26/02/2010
Ethics approval number [1] 290025 0
CF10/0376-2010000170

Summary
Brief summary
Shoulder arthritis can be extremely painful and debilitating and impact on a person's work and life. A solution in appropriate patients is the replace the ball and socket joint of the shoulder and so reduce pain and improve mobility. Historically these replacements have had a long stem in the humerus (long bone of the upper arm) and a new socket in the shoulder where the glenoid bone is. The developments in hip surgery with the replacement of the hip ball and socket, includes a stem which is now much shorter. It is postulated this results in less pain in the femur and may decrease the possibility of mid shaft fracture around the base of the stem. The development in shoulder prostheses has adopted the same concept. Short stem prostheses have been used for several years and this study is not experimental. This study will evaluate whether in this Australian population the short stem ceramic head has greater efficacy than the published studies of the long stem metal head prosthesis in total shoulder replacement. The five year prosthesis outcomes have been submitted for publication and a manuscript on the differences in outcomes between anatomic and reverse prostheses is in final draft. A second analysis will evaluate the efficacy of the Vitamin E enhanced crosslinked polyethylene glenoid component . A study of outcomes in patients 70 and above and below 70 in this cohort is in preparation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43522 0
A/Prof Simon Bell
Address 43522 0
Melbourne Shoulder and Elbow Centre
31 Normanby St., Vic. Brighton 3186
Country 43522 0
Australia
Phone 43522 0
+61 3 95928028
Fax 43522 0
+61 3 95921486
Email 43522 0
[email protected]
Contact person for public queries
Name 43523 0
Jennifer Coghlan
Address 43523 0
Monash University Research Dept, Melbourne Shoulder and Elbow Centre, Suite 1/ 80 Beach Road Sandringham Vic 3191
Country 43523 0
Australia
Phone 43523 0
+61 3 95928028
Fax 43523 0
Email 43523 0
[email protected]
Contact person for scientific queries
Name 43524 0
Simon Bell
Address 43524 0
Melbourne Shoulder and Elbow Centre Suite 1, 80 Beach Road Sandringham VIC 3191
Country 43524 0
Australia
Phone 43524 0
+61 3 95928028
Fax 43524 0
Email 43524 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
data dictionaries, small numbers


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13852Informed consent formNil [email protected] Nil 365116-(Uploaded-21-02-2020-13-45-29)-Study-related document.doc



Results publications and other study-related documents

Documents added manually

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIShort stem shoulder replacement2014https://doi.org/10.4103/0973-6042.140113
Dimensions AIProximal humeral osteolysis and glenoid radiolucent lines in an anatomic shoulder arthroplasty: a comparison of a ceramic and a metal humeral head component2019https://doi.org/10.1016/j.jse.2019.09.032
EmbaseMid-term outcomes of a stemless ceramic head anatomic total shoulder replacement.2022https://dx.doi.org/10.1186/s12891-021-04988-x
N.B. These documents automatically identified may not have been verified by the study sponsor.