Cemented versus uncemented fixation of humeral components in total shoulder arthroplasty for primary osteoarthritis

Cemented versus uncemented fixation of humeral components in total shoulder arthroplasty for primary osteoarthritis: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN75566721

Enrollment

160

Registered

2005-09-26

Start date

2002-04-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Primary osteoarthritis of the shoulder Musculoskeletal Diseases Polyarthrosis

Interventions

Group 1: Cemented fixation of the humeral component in total shoulder arthroplasty Group 2: Uncemented fixation of the humeral component in total shoulder arthroplasty Trial details received: 12 Sept

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Primary osteoarthritis of the shoulder of grade III or higher (Kellgren and Lawrence modified for the shoulder) 2. Aged 18 years and older, either sex

Exclusion criteria

Exclusion criteria: Patients who have failed standard conservative management of their shoulder osteoarthritis

Design outcomes

Primary

Measure	Time frame
The main evaluation of patient outcome is disease specific quality of life comparing the 2 groups at 2 years using several shoulder function rating scales. These include the Western Ontario Osteoarthritis of the Shoulder Index (WOOS), the Constant Score and American Shoulder and Elbow Surgeons (ASES) Standardised Shoulder Assessment form. Overall global health status will be measured and compared at 2 years using the Short Form-12 which has previously been shown to be the most appropriate instrument for evaluating global health status in orthopaedic clinical research.	—

Measure

Time frame

The main evaluation of patient outcome is disease specific quality of life comparing the 2 groups at 2 years using several shoulder function rating scales. These include the Western Ontario Osteoarthritis of the Shoulder Index (WOOS), the Constant Score and American Shoulder and Elbow Surgeons (ASES) Standardised Shoulder Assessment form. Overall global health status will be measured and compared at 2 years using the Short Form-12 which has previously been shown to be the most appropriate instrument for evaluating global health status in orthopaedic clinical research.

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Secondary

Measure	Time frame
The evaluation of radiolucent lines indicative of implant loosening and the incidence of revision surgery complications will be monitored during the 2 year post-operative course.	—

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 12, 2026