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NCT Number: NCT06108934

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St John of God Subiaco Hospital

Subiaco, Western Australia, 6008, Australia

Location status: Recruiting

Location contact

Gavin Clark, MD

CONTACT

[email protected]

+61 8 64891777

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hip stem prosthesis

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.

Primary outcomes

  1. Implant survivorship

    Time frame: 2 years post-operatively

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

Secondary outcomes

  1. Oxford Hip Score

    Time frame: 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

  2. Hip Disability and Osteoarthritis Outcome Score (HOOS-12).

    Time frame: 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.

  3. EQ-5D-5L

    Time frame: 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.

  4. Hip and lower back pain VAS

    Time frame: 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.

  5. Forgotten Joint Score (FJS)

    Time frame: 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.

  6. Complications

    Time frame: 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..

  7. Mortality

    Time frame: 1 and 2 years post-operatively

    Mortality in the intervention group

  8. CPR for stem loosening

    Time frame: 2 years post-operatively

    CPR of the Insignia Hip Stem for stem loosening in the intervention group

  9. Femoral fracture

    Time frame: 2 years post-operatively

    Insignia Hip Stem device-related femoral fracture in the intervention group

Study contacts

Contact information is provided by the study sponsor or research team.

Holly Solomon

CONTACT

[email protected]

+61405307762

Sponsors and collaborators

Lead sponsor

Stryker Australia Pty Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Oct 31, 2023
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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