An interventional study of Hip stem prosthesis in Arthritis (E.G., Degenerative Joint Disease (DJD), Osteoarthritis, and Rheumatoid Arthritis (RA)), sponsored by Stryker Australia Pty Ltd.. Recruiting at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-15.
Sponsored by Stryker Australia Pty Ltd. (part of Stryker) · Not applicable, Interventional, and Treatment
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.
843 studies on the registry are indexed under Arthritis; 118 are open to participants now.
This study's planned enrollment of 313 is above the median of 97 across 599 interventional studies indexed under Arthritis.
Browse Arthritis studies →This is the only study on the registry with Stryker Australia Pty Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Insignia hip stem study group
Device: Hip stem prosthesis
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.
Implant survivorship
Implant survivorship using cumulative percent revision (CPR) of the Insignia hip stem, for any reason.
Time frame: 2 years post-operatively
Oxford Hip Score
Performance of the Insignia hip stem using Oxford Hip Score (OHS) in the intervention group
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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..
Time frame: 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
Time frame: 1 and 2 years post-operatively
CPR for stem loosening
CPR of the Insignia Hip Stem for stem loosening in the intervention group
Time frame: 2 years post-operatively
Femoral fracture
Insignia Hip Stem device-related femoral fracture in the intervention group
Time frame: 2 years post-operatively
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