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Official title A Prospective, Pre-market, Multi-center Study of Insignia Hip Stem in THA to Determine Implant Survivorship and PROMS.
ClinicalTrials.gov ID: NCT06108934
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The patient has signed the study specific, Human Research Ethics Committee (HREC) approved, Patient Information Consent Form for the use of the study...
- 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.
You likely can't join if
- 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...
- 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.
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Subiaco, Western Australia, Australia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Subiaco, Western Australia, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.