100 Participants Needed

Collared vs Collarless Femoral Stems for Hip Replacement Surgery

MH
Overseen ByMiles Hollimon, B.S.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medstar Health Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a prospective randomized control trial comparing two collared and collarless femoral implants used in primary total hip arthroplasty. The specific aims of this trial are to:

SA1: Prospectively assess clinical outcomes in patients undergoing primary total hip arthroplasty with a collared versus collarless femoral stem of the same design.

SA2: Evaluate serial radiographs to quantify differences in subsidence between collared and collarless implant groups.

SA3: Report and compare incidence rates of intraoperative and postoperative periprosthetic fractures and aseptic loosening following primary total hip arthroplasty with use of either a collared or collarless stem.

Hypothesis: The addition of a collar to the same designed triple-taper primary hip stem will lead to a reduction in subsidence and incidence of perioperative and periprosthetic femur fractures.

Are You a Good Fit for This Trial?

This trial is for patients undergoing primary total hip arthroplasty. Participants must meet certain criteria, but specific inclusion and exclusion details are not provided in the information given.

Inclusion Criteria

I am an adult scheduled for a hip replacement without cement.
Ability and willingness to comply with study procedures and follow-up schedule
Ability to provide written informed consent
See 1 more

Exclusion Criteria

Patients not indicated for a cementless THA
Use of cemented or hybrid femoral components
I am having or have had a revision or conversion total hip replacement.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo primary total hip arthroplasty with either a collared or collarless femoral stem

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with radiographic assessments at specified intervals

1 year
3 visits (in-person) at 6 weeks, 6 months, and 1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Collared Femoral Stem
  • Collarless Femoral Stem

Trial Overview

The study compares two types of femoral implants: one with a collar and one without, in hip replacement surgeries. It aims to assess clinical outcomes, measure implant subsidence through X-rays, and track fracture rates post-surgery.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Collard stemActive Control1 Intervention
Group II: Collarless stemActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medstar Health Research Institute

Lead Sponsor

Trials
202
Recruited
187,000+