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

Stryker Australia Pty Ltd.313 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

313

Conditions

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

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Implant survivorship

Implant survivorship using cumulative percent revision (CPR) of the Insignia hip stem, for any reason.

Time frame: 2 years post-operatively