Comparing Collared and Collarless Femoral Stems in Primary Total Hip Arthroplasty

NCT ID: NCT07337642

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-03

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Total Hip Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Collard stem

Group Type ACTIVE_COMPARATOR

Collared Femoral Stem

Intervention Type OTHER

Patients will be randomized to one of two groups receiving either a collarless or collared femoral stem. Patients randomized to this group will receive a collared femoral stem at the time of surgery.

Collarless stem

Group Type ACTIVE_COMPARATOR

Collarless Femoral Stem

Intervention Type OTHER

Patients will be randomized to one of two groups receiving either a collarless or collared femoral stem. Patients randomized to this group will receive a collarless femoral stem implant at time of surgery.

Interventions

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Collarless Femoral Stem

Patients will be randomized to one of two groups receiving either a collarless or collared femoral stem. Patients randomized to this group will receive a collarless femoral stem implant at time of surgery.

Intervention Type OTHER

Collared Femoral Stem

Patients will be randomized to one of two groups receiving either a collarless or collared femoral stem. Patients randomized to this group will receive a collared femoral stem at the time of surgery.

Intervention Type OTHER

Other Intervention Names

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Collarless collared

Eligibility Criteria

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Inclusion Criteria

* Adults (≥ 18 years old) scheduled for primary, uncemented THA using a cementless femoral stem
* Diagnosis of primary osteoarthritis or other non-inflammatory degenerative joint disease.
* 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
* Prior surgery on the ipsilateral hip (e.g., prior THA, internal fixation, osteotomy)
* Use of cemented or hybrid femoral components.
* Revision THA or conversion THA
* Active or prior infection of the hip joint.
* Severe osteoporosis (T-score ≤ -2.5) or known metabolic bone disease.
* Inability to complete follow-up or anticipated relocation out of the area.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medstar Health Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Miles Hollimon, B.S.

Role: CONTACT

(202) 444-8766

Facility Contacts

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Miles Hollimon, B.S.

Role: primary

(202) 444-8766

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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STUDY00009612

Identifier Type: -

Identifier Source: org_study_id

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