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OpenTrials
Active, Not Recruiting

NCT Number: NCT05313321

Survival of the Insignia Stem in Total Hip Arthroplasty

The investigators primary objective of this study is to evaluate radiographic fit and fill of the Insignia stem and identify risk factors for aseptic failure. The investigators hypotheses being tested is: the newly designed Insignia stem demonstrates acceptable radiographic fit and fill by reviewing radiolucent lines <2mm.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

About this study

Total hip arthroplasty is one of the most functionally restorative procedures in modern medicine. Since its introduction in the mid twentieth century significant advancements in implant materials have occurred. There is debate on the design of the femoral stem in total hip arthroplasty. The use of uncemented, Hydroxyapatite (HA)-coated femoral stems have been shown to be reliable and are commonly used. One such implant is the Insignia™ Hip Stem (Stryker, Kalamazoo, MI, USA).

The Insignia™ Hip Stem is a collared stem that features a plasma-sprayed Hydroxyapatite (HA) coating over plasma-sprayed titanium in the proximal region and a plasma-sprayed HA coating over grit blast in the distal region and collar underside. Unfortunately, with it's novelty comes a lack of clinical follow-up and evaluation. As such, the investigators purpose of this study is to evaluate the early radiographic of the Insignia™ Hip Stem.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients age ≥18
  • Patients planning on undergoing primary total hip arthroplasty that will likely receive the Insignia stem and associated Stryker Acetabular Component.
  • Preoperative diagnosis of osteoarthritis
  • Patients willing and able to comply with follow-up requirements
  • Patients willing to sign an IRB approved consent and authorization document

Exclusion criteria

  • Patients with inflammatory or pyogenic arthritis
  • Body Mass Index (BMI)>40
  • Bone stock that is inadequate for support or fixation of the prosthesis

Treatment and study plan

Primary total hip arthroplasty receiving the Insignia Stem

Device

Patients receiving the Insignia Stem and associated Stryker Acetabular Component for total hip arthroplasty

Other names: Total Hip Arthroplasty

Primary outcomes

  1. Radiographs review

    Time frame: Pre-operative

    Reviewing radiographic radiolucent lines <2mm

  2. Radiographs review

    Time frame: 6-weeks post-operative

    Reviewing radiographic radiolucent lines <2mm

  3. Radiographs review

    Time frame: 1-year post-operative

    Reviewing radiographic radiolucent lines <2mm

  4. Radiographs review

    Time frame: 2-years post-operative

    Reviewing radiographic radiolucent lines <2mm

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

Mid-term Survival of the Insignia Stem in Primary Total Hip Arthroplasty

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Apr 6, 2022
Registry last updated
Jan 9, 2026

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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