A prospective, pre-market, multi-center study of the Insignia hip stem in total hip replacement surgery to determine implant survivorship (revision rate) and patient reported outcome measures (PROMs).

A prospective, pre-market, multi-center evaluation of the clinical outcomes of the Insignia Hip Stem in Total Hip Arthroplasty (THA)

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12623000391673

Enrollment

313

Registered

2023-04-18

Start date

2023-11-01

Completion date

Unknown

Last updated

2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

The Insignia hip stem prosthesis will be used in cementless THA surgery. The surgery typically takes approximately two hours. All study participants will receive the Insignia hip stem and compatible components. There are seven hospitals in Australia participating in this study. Seven experienced Orthopaedic Surgeons trained in THA will perform the surgeries as per the standard surgical technique guide for this prosthesis.

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results