A Prospective, Pre-market, Multi-center Study of Insignia Hip Stem in THA to Determine Implant Survivorship and PROMS.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the survivorship (revision rates) and patient reported outcomes (PROMs) following implantation of the Insignia hip stem in patients undergoing cementless total hip replacement surgery compared to currently available stems used for the same type of surgery. It is hypothesised the 2-year survivorship of the Insignia stem is noninferior to the benchmark survivorship of similar stems used in the same type of surgery.

Official Title
-----------------
A Prospective, Pre-market, Multi-center Evaluation of the Clinical Outcomes of the Insignia Hip Stem in Total Hip Arthroplasty (THA)

Conditions
-----------------
Arthritis (E.G., Degenerative Joint Disease (DJD), Osteoarthritis, and Rheumatoid Arthritis (RA))

Intervention / Treatment
-----------------
* Device: Hip stem prosthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient has signed the study specific, Human Research Ethics Committee (HREC) approved, Patient Information Consent Form for the use of the study device Primary non-inflammatory degenerative joint disease (including osteoarthritis or avascular necrosis) and/or rheumatoid arthritis The patient is a candidate for a primary cementless THA. Patients who are informed of the conditions of the study and are willing to participate for the length of the prescribed follow-up period. Exclusion Criteria: Active or suspected latent infection in or about the affected hip joint and the time of study device implantation. Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure or complications in post-operative care. Has bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis. Is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. >30 days.) Requires revision THA or hip fusion to the affected joint. Has known sensitivity to device materials. Any involvement in an active Workers' Compensation investigation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Insignia hip stem study group | Device: Hip stem prosthesis<br>* The Insignia hip stem prosthesis will be used in cementless total hip replacement surgery (THA). The surgery typically takes approximately two hours. All study participants will receive the Insignia hip stem and compatible components. Experienced Orthopaedic Surgeons trained in THA will perform the surgeries as per the standard surgical technique guide for this prosthesis.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survivorship | Implant survivorship using cumulative percent revision (CPR) of the Insignia hip stem, for any reason. | 2 years post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford Hip Score | Performance of the Insignia hip stem using Oxford Hip Score (OHS) in the intervention group | Pre-operatively and 6 months, 12 months and 2 years post-operatively | 
| Hip Disability and Osteoarthritis Outcome Score (HOOS-12). | Function, pain and satisfaction in the intervention group using the Hip Disability and Osteoarthritis Outcome Score mid-version (HOOS-12). This is a composite measure. | Pre-operatively and 6 months, 12 months and 2 years post-operatively | 
| EQ-5D-5L | Function, pain and satisfaction in the intervention group using EQ-5D-5L domains and EQ (Visual analogue scale) VAS. This is a composite measure. | Pre-operatively and 6 months, 12 months and 2 years post-operatively | 
| Hip and lower back pain VAS | Hip and lower back pain in the intervention group using a VAS. This is a composite measure. | Pre-operatively and 6 months, 12 months and 2 years post-operatively | 
| Forgotten Joint Score (FJS) | Function, pain and satisfaction in the intervention group using Forgotten Joint Score (FJS). This is a composite measure. | Pre-operatively and 6 months, 12 months and 2 years post-operatively | 
| Complications | Post-operative complications when the Insignia Hip Stem is used in THA in the intervention group.. | Collected as they arise post-operatively. Reported as number within 6 months, 12 months and 2 years post-operatively. | 
| Mortality | Mortality in the intervention group | 1 and 2 years post-operatively | 
| CPR for stem loosening | CPR of the Insignia Hip Stem for stem loosening in the intervention group | 2 years post-operatively | 
| Femoral fracture | Insignia Hip Stem device-related femoral fracture in the intervention group | 2 years post-operatively |