Clinical outcome study following Total Hip Replacement using the Paragon femoral stem and Global acetabular cup prostheses

Active, not recruiting

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

• Registration Number: ACTRN12614000294651
• 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: 2014-03-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

The individual clinically qualifies for primary total hip arthroplasty surgery.
-The individual is diagnosed with a primary diagnosis of non-Inflammatory Degenerative Joint Disease.
-The individual is physically and mentally willing and able to comply with post-operative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria

-The individual has an active infection within the affected hip joint.
-The individual has had a 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
Evaluate the safety and performance of the Paragon femoral stem and the Global acetabular cup. Patient clinical and radiographic outcomes will be analysed through 2 years post surgery.[Pre-operative, 1 week, 6 weeks, 6 months and 2 years]

Secondary Outcome Measures

Name	Time	Method
Patient Quality of Life and clinical and functional evaluation will be measured using the,<br><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>Oxford Hip Score - a disease specific assessment that evaluates hip pain, symptoms and related function.<br>Pain Visual Analogue Scale (VAS) - a simple assessment tool consisting of a horizontal 100 mm line, where the endpoints are labelled ‘no pain’, and ‘extreme pain’ that the patient places a vertical line through the horizontal line to monitor their own perception of their pain and its severity.[Pre-operative, 6 weeks, 6 months and 2 years]