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

NCT ID: NCT06108934

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 313 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-22
• Study Completion Date: 2028-12-31

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.

Conditions

Arthritis (E.G., Degenerative Joint Disease (DJD), Osteoarthritis, and Rheumatoid Arthritis (RA))

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

Insignia hip stem study group

Group Type: EXPERIMENTAL

Hip stem prosthesis

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Australia Pty Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gavin Clark, MD

Role: PRINCIPAL_INVESTIGATOR

Perth Hip and Knee

Locations

St John of God Subiaco Hospital

Subiaco, Western Australia, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Holly Solomon

Role: CONTACT

holly.solomon@stryker.com

+61405307762

Facility Contacts

Gavin Clark, MD

Role: primary

clark@hipnknee.com.au

+61 8 64891777

Other Identifiers

Insignia-23

Identifier Type: -

Identifier Source: org_study_id