Collared vs Collarless Femoral Stems for Hip Replacement Surgery

Overseen By Miles Hollimon, B.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medstar Health Research Institute

Disqualifiers: Prior hip surgery, Severe osteoporosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 day

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of implants for hip replacement surgery: one with a collar (Collared Femoral Stem) and one without (Collarless Femoral Stem). The goal is to determine which implant performs better for individuals with hip issues like osteoarthritis, a joint disease causing pain and stiffness. Researchers will compare the implants' stability and their effectiveness in reducing fracture risk during and after surgery. Ideal participants are adults with hip damage from joint diseases who plan to receive a hip replacement using a cementless implant. As an unphased trial, this study allows participants to contribute to valuable research that may enhance future hip replacement outcomes.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these femoral stems are safe for hip replacement surgery?

Research has shown that both collared and collarless femoral stems used in hip replacements yield excellent long-term results. Patients report good outcomes with both types, though some safety differences exist.

Studies indicate that collared stems carry a lower risk of complications. They are four times less likely to cause fractures during and after surgery compared to collarless stems, reducing the likelihood of breakage or the need for a second surgery. Specifically, one study found the risk of complications with collared stems to be only 0.02 compared to collarless stems.

Conversely, collarless stems have a higher rate of early revision surgeries. They are more prone to moving out of place post-surgery and have a greater risk of requiring additional surgeries due to fractures.

In summary, while both collared and collarless femoral stems are generally safe, collared stems demonstrate a better safety record with fewer complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial comparing collared and collarless femoral stems for hip replacement surgery because both options have potential advantages. Collared femoral stems are designed to provide extra stability by anchoring into the bone better, which can help reduce the risk of implant loosening. On the other hand, collarless stems offer a more straightforward design, potentially leading to easier implantation and quicker recovery times. By comparing these two approaches, researchers hope to determine which design offers better outcomes for patients in terms of stability, recovery, and long-term success.

What evidence suggests that this trial's treatments could be effective for hip replacement surgery?

This trial will compare collared femoral stems with collarless femoral stems for hip replacement surgery. Research has shown that both types of femoral stems—those with collars and those without—are effective in the long run. Studies suggest that stems with collars might lower the risk of complications, such as breaks near the implant, compared to those without collars. Specifically, collared stems have a very low complication rate of 0.02. Meanwhile, collarless stems have also proven durable, with some studies indicating a 92% success rate over 30 years. In summary, both designs work well, but collared stems may provide extra protection against certain issues. ^{1 3 5 6 7}

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

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.

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?

Group I: Collard stem Active Control 1 Intervention

Group II: Collarless stem Active Control 1 Intervention

Who Is Running the Clinical Trial?

Medstar Health Research Institute

Lead Sponsor

Trials

202

Recruited

187,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11044085/

Outcomes of total hip arthroplasty using collared versus ...

Both collared and collarless uncemented femoral stems demonstrated excellent long-term survival and patient-reported outcomes for primary total hip ...

2.

boneandjoint.org.uk

boneandjoint.org.uk/Article/10.1302/0301-620X.106B9.BJJ-2024-0353/pdf

The impact of a femoral stem collar on primary hip arthroplasty

This article discusses the influence of a collar on the migration of a femoral component, its outcomes, and the risk of periprosthetic fracture following THA.

3.

cureus.com

cureus.com/articles/201822-five-year-survivorship-of-total-hip-arthroplasty-with-a-proximally-coated-medially-collared-triple-tapered-femoral-stem-a-retrospective-multicenter-registry-review

Five-Year Survivorship of Total Hip Arthroplasty With a ...

In this cohort of 5,264 medially collared, hydroxyapatite-coated, triple-tapered stems, the midterm clinical outcomes were excellent.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07337642

Comparing Collared and Collarless Femoral Stems in ...

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

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/31363848/

Comparative outcomes between collared versus collarless ...

Indirect meta-analysis shows that collared femoral stem provided a lower risk of complications of 0.02 (95%CI 0.001, 0.30) when compared to collarless femoral ...

6.

arthroplastyjournal.org

arthroplastyjournal.org/article/S0883-5403(24)01108-2/fulltext

Is There a Difference in Outcomes Between Collared and ...

The use of both collared and noncollared uncemented femoral stems result in an excellent clinical outcome in patients undergoing total hip arthroplasty (THA).

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1877056825003949

Does a Collar Reduce Revision Rates and Periprosthetic ...

Data from a German registry have supported the strong effect of the collar, with intra- and postoperative fracture risks reduced fourfold ...