Evaluation of radiographic and clinical outcomes following Absolut femoral prosthesis and Global acetabular cup total hip replacement surgery

Not Applicable

Recruiting

• Conditions: Degenerative Joint Disease; primary Total Hip Arthroplasty; Surgery - Other surgery; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12614000318684
• Lead Sponsor: Global Orthopaedic Technology Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

The individual is diagnosed with a primary diagnosis of Degenerative Joint Disease.

Exclusion Criteria

-The individual has an active infection within the affected hip joint.
-The individual has had previous total hip replacement or hip fusion of the affected hip joint.
-The individual has a neuromuscular or neurosensory deficit which limits the ability to evaluate safety and effectiveness of the device or has a systemic disease that would affect the subject's welfare or overall outcome of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the performance of the Absolut cemented femoral stem with the Global acetabular cup. Patient clinical and radiolographic outcomes will be analysed through 10 years post surgery.[Pre-operative, post-operative, 6 weeks, 12 month, 2, 5 and 10 years]

Secondary Outcome Measures

Name	Time	Method
Patient Quality of Life questionnaires, clinical and functional evaluation.<br><br>The measurement tools will be:<br>Assessment of Quality of Life AQoL 6D - a descriptive system of health-related quality of life statements consisting of six dimensions (Independent Living, Mental Health, Coping, Relationships, Pain, Senses) with variable item numbers and response levels.<br><br>Oxford Hip - a disease specific assessment tool that evaluates pain, symptoms and function.<br><br>Pain Visual Analogue Scale (VAS) - a tool that monitors the patient’s own perception of their pain and its severity.[Pre-operative and post-operative at 6 weeks, 12 months, 2, 5, 10 years]