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Recruiting NCT06108934

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

No phase Interventional Arthritis (E.G., Degenerative Joint Disease (DJD), Osteoarthritis, and Rheumatoid Arthritis (RA))

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hip stem prosthesis.
Who it may be relevant to
Registry conditions: Arthritis (E.G., Degenerative Joint Disease (DJD), Osteoarthritis, and Rheumatoid Arthritis (RA)). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • Device 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.

Primary outcome measures

  • Implant survivorship [Time frame: 2 years post-operatively]
Secondary outcome measures (9)
  • Oxford Hip Score [Time frame: Pre-operatively and 6 months, 12 months and 2 years post-operatively]
  • Hip Disability and Osteoarthritis Outcome Score (HOOS-12). [Time frame: Pre-operatively and 6 months, 12 months and 2 years post-operatively]
  • EQ-5D-5L [Time frame: Pre-operatively and 6 months, 12 months and 2 years post-operatively]
  • Hip and lower back pain VAS [Time frame: Pre-operatively and 6 months, 12 months and 2 years post-operatively]
  • Forgotten Joint Score (FJS) [Time frame: Pre-operatively and 6 months, 12 months and 2 years post-operatively]
  • Complications [Time frame: Collected as they arise post-operatively. Reported as number within 6 months, 12 months and 2 years post-operatively.]
  • Mortality [Time frame: 1 and 2 years post-operatively]
  • CPR for stem loosening [Time frame: 2 years post-operatively]
  • Femoral fracture [Time frame: 2 years post-operatively]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Australia · 1 center
  • St John of God Subiaco Hospital — Subiaco

Identifiers

NCT: NCT06108934 · Insignia-23

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗