ANZCTR - Registration

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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 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]

Nil

Universal Trial Number (UTN)

Trial acronym

Nil

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Shoulder Arthritis

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Inflammatory and Immune System

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]

Treatment: Surgery

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Reduction in pain compared with pre-operation. Self assessed on a VAS of 0= no pain to 10= worst pain imaginable.

Timepoint [1]

2 weeks, 6-8 weeks and annually for 2 years

Primary outcome [2]

Evaluation of validated shoulder scores, ASES, SPADI, ASES and Constant compared with pre-operation.

Timepoint [2]

6 weeks and annually for two years

Primary outcome [3]

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]

6 weeks and annually thereafter for 15 to 20 years until radiolucent lines indicate prosthesis failure.

Secondary outcome [1]

Patient satisfaction with surgical outcome.

Timepoint [1]

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?

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

Accrual to date

Final

190

Recruitment in Australia

Recruitment state(s)

NSW,VIC

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Mathys Limited Bettlach,Mathys Orthopaedics Pty Ltd

Address [1]

76 Reserve Rd, Artarmon NSW 2064

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics

Ethics committee address [1]

Building 3E, Room 111,Clayton Campus, Wellington Road, Clayton  Vic 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

26/02/2010

Ethics approval number [1]

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

A/Prof Simon Bell

Address

Melbourne Shoulder and Elbow Centre
31 Normanby St., Vic. Brighton 3186

Country

Australia

Phone

+61 3 95928028

Fax

+61 3 95921486

[email protected]

Contact person for public queries

Name

Jennifer Coghlan

Address

Monash University Research Dept, Melbourne Shoulder and Elbow Centre, Suite 1/ 80 Beach Road Sandringham Vic 3191

Country

Australia

Phone

+61 3 95928028

Fax

[email protected]

Contact person for scientific queries

Name

Simon Bell

Address

Melbourne Shoulder and Elbow Centre Suite 1, 80 Beach Road Sandringham VIC 3191

Country

Australia

Phone

+61 3 95928028

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

data dictionaries, small numbers

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
13852	Informed consent form	Nil		[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

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Short stem shoulder replacement	2014	https://doi.org/10.4103/0973-6042.140113
Dimensions AI	Proximal humeral osteolysis and glenoid radiolucent lines in an anatomic shoulder arthroplasty: a comparison of a ceramic and a metal humeral head component	2019	https://doi.org/10.1016/j.jse.2019.09.032
Embase	Mid-term outcomes of a stemless ceramic head anatomic total shoulder replacement.	2022	https://dx.doi.org/10.1186/s12891-021-04988-x

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically