Survival of the Insignia Stem in Total Hip Arthroplasty

Primary Total Hip Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05313321
• Other study ID #: 145076
• Status: Enrolling by invitation
• Start date: March 17, 2022
• Est. completion date: March 2026

Study information

• Verified date: January 2024
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Primary Total Hip Arthroplasty

Intervention

Device:
• Primary total hip arthroplasty receiving the Insignia Stem
Patients receiving the Insignia Stem and associated Stryker Acetabular Component for total hip arthroplasty

Locations

Country	Name	City	State
United States	University of Utah Orthopaedic Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographs review	Reviewing radiographic radiolucent lines <2mm	Pre-operative
Primary	Radiographs review	Reviewing radiographic radiolucent lines <2mm	6-weeks post-operative
Primary	Radiographs review	Reviewing radiographic radiolucent lines <2mm	1-year post-operative
Primary	Radiographs review	Reviewing radiographic radiolucent lines <2mm	2-years post-operative