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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613001183774
Acronym
Nil
Enrollment
190
Registered
2013-10-29
Start date
2012-04-22
Completion date
2014-04-22
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.. The five year outcomes and the outcomes comparing the Anatomic shoulder replacement and reverse shoulder replacements of younger and older than 75 years have been published.

Interventions

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 lin

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.

Sponsors

A/Professor Simon Bell
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
35 Years to 80 Years
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 13, 2026