St John of God Subiaco Hospital
Subiaco, Western Australia, 6008, Australia
Location status: Recruiting
NCT Number: NCT06108934
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Subiaco, Western Australia, 6008, Australia
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 2 years post-operatively
Implant survivorship using cumulative percent revision (CPR) of the Insignia hip stem, for any reason.
Time frame: Pre-operatively and 6 months, 12 months and 2 years post-operatively
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
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
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 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
Function, pain and satisfaction in the intervention group using Forgotten Joint Score (FJS). This is a composite measure.
Time frame: Collected as they arise post-operatively. Reported as number within 6 months, 12 months and 2 years post-operatively.
Post-operative complications when the Insignia Hip Stem is used in THA in the intervention group..
Time frame: 1 and 2 years post-operatively
Mortality in the intervention group
Time frame: 2 years post-operatively
CPR of the Insignia Hip Stem for stem loosening in the intervention group
Time frame: 2 years post-operatively
Insignia Hip Stem device-related femoral fracture in the intervention group
Contact information is provided by the study sponsor or research team.
Stryker Australia Pty Ltd.
Industry
A Prospective, Pre-market, Multi-center Evaluation of the Clinical Outcomes of the Insignia Hip Stem in Total Hip Arthroplasty (THA)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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