Primary Total Hip ArthroplastyNCT07337642
Comparing Collared and Collarless Femoral Stems in Primary Total Hip Arthroplasty
A study testing Collarless Femoral Stem and Collared Femoral Stem in people with Primary Total Hip Arthroplasty, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Primary Total Hip Arthroplasty
- What is being tested?
- Collarless Femoral Stem and Collared Femoral Stem
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Miles Hollimon, B.S., (202) 444-8766, miles.hollimon@medstar.net
About this study
Official title: Comparing Collared and Collarless Femoral Stems in Total Hip Arthroplasty
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.
Read more
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.
- Conditions
- Primary Total Hip Arthroplasty
- Being tested
- Collarless Femoral Stem, Collared Femoral Stem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collarless Femoral StemOther
Also called Collarless
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.
Collared Femoral StemOther
Also called collared
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.
| Study group | Role | What they receive |
|---|---|---|
| Collard stem | Active comparator | Not described Receives: Other: Collared Femoral Stem |
| Collarless stem | Active comparator | Not described Receives: Other: Collarless Femoral Stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of femoral stem subsidence at 6 weeks, 6 months, and 1-year post-operation
Measurement of femoral stem subsidence at 6 weeks, 6 months, and 1-year post-operation used radiographic evidence.
Measured: 6 weeks, 6 months, and 1 year post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start3 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Total Hip ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337642
- Sponsor's protocol ID
- STUDY00009612
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Collared and Collarless Femoral Stems in Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT07337642
- Acronym / sponsor ID
- STUDY00009612
- Conditions
- Primary Total Hip Arthroplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collard stem | Active comparator | Other: Collared Femoral Stem |
| Collarless stem | Active comparator | Other: Collarless Femoral Stem |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collarless Femoral StemAlso: CollarlessPatients 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. | Other | Collarless stem |
| Collared Femoral StemAlso: collaredPatients 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. | Other | Collard stem |
Primary outcome
Measurement of femoral stem subsidence at 6 weeks, 6 months, and 1-year post-operation
Time frame: 6 weeks, 6 months, and 1 year post operation
Measurement of femoral stem subsidence at 6 weeks, 6 months, and 1-year post-operation used radiographic evidence.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collarless Femoral Stem and Collared Femoral Stem in people with Primary Total Hip Arthroplasty, run by Medstar Health Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miles Hollimon, B.S. ((202) 444-8766, miles.hollimon@medstar.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of femoral stem subsidence at 6 weeks, 6 months, and 1-year post-operation (time frame: 6 weeks, 6 months, and 1 year post operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.