Radiographic evaluation of the Paragon femoral stem over 2 years post hip replacement surgery

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000060549
• Date of registration: 23/01/2015
• Prospective Registration: No
• Primary sponsor: Global Orthopaedic Technology Pty Ltd
• Public title: Radiographic evaluation of the Paragon femoral stem over 2 years post hip replacement surgery
• Scientific title: Prospective clinical trial assessing subsidence and rotation after Paragon hip stem arthroplasty in patients with a primary diagnosis of non-inflammatory degenerative joint disease
• Date of first enrolment: 12/12/2014
• Target sample size: 50
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000060549.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Mr Lyndon Crossley

• Name: Mr Lyndon Crossley

Key inclusion & exclusion criteria

Inclusion criteria: The individual clinically qualifies for a primary total hip replacment using the Paragon cementless hip stem study prosthesis.
The individual has a primary diagnosis of non-inflammatory degenerative joint disease.
The individual has signed a study specifc informed consent.
The individual is physically and mentally willing and able to comply with pre-operative and post-operative assessments and procedures.


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 to the affected hip joint.
The individual has a neuromuscular or neurosensory deficit which limits the ability to assess the performance of the prosthesis.


Age minimum: 21 Years
Age maximum: 85 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

non-inflammatory degenerative joint disease;
non-inflammatory degenerative joint disease

Musculoskeletal - Osteoarthritis

Surgery - Surgical techniques

Intervention(s)

Patients undergoing primary total hip replacement and suitable for the cementless Paragon hip stem will be selected. Radiographic visible tantalum beads are inserted around the hip prosthesis during surgery. The procedure adds approx 10 minutes to the standard total hip replacment surgery time.

Primary Outcome(s)

To determine the movement patterns of the Paragon femoral stem for the first 2 years post surgery using radiostereogrammetric analysis.[Post-operative at,
6 weeks
6 months
12 months
24 months]

Secondary Outcome(s)

Functional evaluation will be measured pre-operative to post-operative using the Oxford Hip Score. [Pre-operative
Post-operative at,
6 weeks
6 months
12 months
24 months]

Health related quality of life evaluation will be measured using the EQ-5D questionnaire.[Pre-operative
Post-operative at,
6 weeks
6 months
12 months
24 months]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Global Orthopaedic Technology Pty Ltd

Ethics review

Status: Approved
Approval date:
Contact:

Nepean Blue Mountains Local Health District HREC