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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Arthritis (E.G., Degenerative Joint Disease (DJD), Osteoarthritis, and Rheumatoid Arthritis (RA))
• Intervention / Treatment: Device: Hip stem prosthesis

• Study Type: Interventional
• Enrollment (Estimated): 313
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Holly Solomon; Phone Number: +61405307762; Email: holly.solomon@stryker.com

Study Locations

• Australia
  • Western Australia
    • Subiaco, Western Australia, Australia, 6008
      • Recruiting
      • St John of God Subiaco Hospital
      • Contact: Gavin Clark, MD; Phone Number: +61 8 64891777; Email: clark@hipnknee.com.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention group; 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.

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

Collaborators and Investigators

• Sponsor: Stryker Australia Pty Ltd.
• Investigators: Principal Investigator: Gavin Clark, MD, Perth Hip and Knee

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: October 25, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Joint Diseases; Osteoarthritis
• Other Study ID Numbers: Insignia-23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes