None listed
Conditions
Brief summary
Radiographic evaluation using RSA method to measure migration and stability of the Paragon femoral stem over 2 years post-surgery. Functional evaluation using the Oxford Hip Score. Health related quality of life evaluation using the EQ-5D questionnaire.
Interventions
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.
Sponsors
Global Orthopaedic Technology Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
21 Years to 85 Years
Healthy volunteers
No
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.
Outcome results
None listed