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

Not Applicable

Recruiting

• Conditions: Arthritis (E.G., Degenerative Joint Disease (DJD), Osteoarthritis, and Rheumatoid Arthritis (RA))
• Interventions: Device: Hip stem prosthesis

• Registration Number: NCT06108934
• Lead Sponsor: Stryker Australia Pty Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-18
• Study First Submitted QC: 2023-10-25
• Study First Posted: 2023-10-31
• Study Start: 2024-02-22
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-15
• Primary Completion: 2028-03
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 313

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention group	Hip stem prosthesis	Insignia hip stem study group

Primary Outcome Measures

Name	Time	Method
Implant survivorship	2 years post-operatively	Implant survivorship using cumulative percent revision (CPR) of the Insignia hip stem, for any reason.

Secondary Outcome Measures

Name	Time	Method
Hip Disability and Osteoarthritis Outcome Score (HOOS-12).	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.
Hip and lower back pain VAS	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.
EQ-5D-5L	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.
Oxford Hip Score	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
Femoral fracture	2 years post-operatively	Insignia Hip Stem device-related femoral fracture in the intervention group
Forgotten Joint Score (FJS)	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.
Complications	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..
Mortality	1 and 2 years post-operatively	Mortality in the intervention group
CPR for stem loosening	2 years post-operatively	CPR of the Insignia Hip Stem for stem loosening in the intervention group

Trial Locations

Locations (1)

St John of God Subiaco Hospital; 🇦🇺 Subiaco, Western Australia, Australia