A prospective, observational, cohort study of the MASTER-SL Femoral stem in patients with degenerative disease of the hip

Not Applicable

Completed

• Conditions: Osteoarthritis; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12617000550303
• Lead Sponsor: The Orthopaedic Institute of Queensland (ORIQL)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-19
• Study Completion: 2017-10-30
• Last Update Posted: 11 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Male and female >18 years;
radiologically confirmed diagnosis of primary osteoarthritis (OS) of the hip and suitable for primary total hip replacement;
Life expectancy of > 10 years
Receiving a MASTER-SL femoral stem
Voluntary written informed consent obtained

Exclusion Criteria

Prospect for recovery to independent mobility compromised by known coexistent, medical problems;
Requiring revision hip replacement;
Loss of abductor musculature, poor bone stock, or poor skin coverage around the hip join;
Previous organ transplant;
Previous hip replacement (resurfacing or THR) on the contra-lateral side within the last 6 months;
Previous hip replacement (resurfacing or THR) on the contralateral side and whose outcome is achieving an Oxford Hip score <18 points;
Body mass index > 40 kg/m2
Active or suspected infection;
Known sensitivity to device materials;
Pregnant woman

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Outcome Scores: harris Hip Score, [Pre-Operative, 6 weeks post op, 6 months post-op, 1 year post op, 2 year Post op];Outcome score: Oxford Hip [Pre-Operative, 6 weeks post op, 6 months post-op, 1 year post op, 2 year Post op];Outcome score: Non arthritic hip score[Pre-Operative, 6 weeks post op, 6 months post-op, 1 year post op, 2 year Post op]

Secondary Outcome Measures

Name	Time	Method
Outcome Score: EQ5D 5L[Pre-Operative, 6 weeks post op, 6 months post-op, 1 year post op, 2 year Post op];Revision surgery during the observation follow up period due to prosthesis failure[2 year follow up]