Clinical trial NCT06108934: A Prospective, Pre-market, Multi-center Study of Insignia Hip Stem in THA to Determine Implant Survivorship and PROMS.
Official title: A Prospective, Pre-market, Multi-center Evaluation of the Clinical Outcomes of the Insignia Hip Stem in Total Hip Arthroplasty (THA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arthritis (E.G., Degenerative Joint Disease (DJD), Osteoarthritis, and Rheumatoid Arthritis (RA))
Lead sponsor: Stryker South Pacific
Sponsor class: INDUSTRY
First posted: 2023-10-31
Enrollment: 313
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Implant survivorship
timeFrame: 2 years post-operatively
Secondary outcomes:
measure: Oxford Hip Score
timeFrame: Pre-operatively and 6 months, 12 months and 2 years post-operatively
measure: Hip Disability and Osteoarthritis Outcome Score (HOOS-12).
timeFrame: Pre-operatively and 6 months, 12 months and 2 years post-operatively
measure: EQ-5D-5L
timeFrame: Pre-operatively and 6 months, 12 months and 2 years post-operatively
measure: Hip and lower back pain VAS
timeFrame: Pre-operatively and 6 months, 12 months and 2 years post-operatively
measure: Forgotten Joint Score (FJS)
timeFrame: Pre-operatively and 6 months, 12 months and 2 years post-operatively
measure: Complications
timeFrame: Collected as they arise post-operatively. Reported as number within 6 months, 12 months and 2 years post-operatively.
measure: Mortality
timeFrame: 1 and 2 years post-operatively
measure: CPR for stem loosening
timeFrame: 2 years post-operatively
measure: Femoral fracture
timeFrame: 2 years post-operatively
Other outcomes:
Locations:
city: Subiaco
country: Australia
facility: St John of God Subiaco Hospital
state: Western Australia
Study officials:
affiliation: Perth Hip and Knee
name: Gavin Clark, MD
role: PRINCIPAL_INVESTIGATOR
References: