Total Hip ArthroplastyNCT01566916
Medium Term Survivorship of Cementless THA Performed Using the Bone Preservation Tri-Lock Femoral Stem
A study testing Total Hip Arthroplasty in people with Total Hip Arthroplasty, run by Rothman Institute Orthopaedics at 2 sites in United States.
Trial summary
This prospective, randomized study will study the 2 year survivorship and short term outcomes of a currently-used femoral stem: the Bone Preservation Tri-Lock femoral stem using two surgical approaches. The surgical approaches being studied are direct anterior and anterolateral. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- Total Hip Arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient signed an IRB, study specific informed patient consent
- Patient is a male or non-pregnant female age 21 years or older at the time of study device implantation
- Patient has primary diagnosis of non-inflammatory degenerative joint disease.
- Patient is a candidate for primary cementless total hip replacement
- Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Who cannot join
- Patient has a Body Mass Index (BMI) > 40 Kg/m2
- Patient has an active or suspected infection at the time of device implantation
- Patient is immunologically suppressed.
- Patient requires revision surgery of a previously implanted total hip replacement
- Patient has a known sensitivity to device materials
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rothman Institute
Egg Harbor, New Jersey, 08234
Rothman Institute
Philadelphia, Pennsylvania, 19107
About this study
This prospective, randomized study will study the 2 year survivorship and short term outcomes of a currently-used femoral stem: the Bone Preservation Tri-Lock femoral stem using two surgical approaches. The surgical approaches being studied are direct anterior and anterolateral. Implant survivorship, radiographic positioning, and functional outcomes will be compared. Subjects will be randomized to surgical approach and followed for a period of two years.
- Conditions
- Total Hip Arthroplasty
- Being tested
- Total Hip Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip ArthroplastyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Total Hip Arthroplasty performed via direct anterior approach | Active comparator | Not described Receives: Procedure: Total Hip Arthroplasty |
| Total Hip Arthroplasty using anterolateral approach | Active comparator | Not described Receives: Procedure: Total Hip Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivorship of Bone Preservation Tri-Lock femoral stem
Survivorship will be assessed via radiographic (x-ray) analysis and need for revision surgery (if patient had femoral stem removed for any reason within the first two years after surgery).
Measured: 2 years post-op
Secondary outcomes (1)
TUG (timed up and go) Score
Measured: 6 weeks post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566916
- Sponsor's protocol ID
- RIFJPAR 12-01
- Status last verified
- Feb 2014
- First submitted
- 24 Feb 2012
- Last updated
- 12 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medium Term Survivorship of Cementless THA Performed Using the Bone Preservation Tri-Lock Femoral Stem
- ClinicalTrials.gov ID
- NCT01566916
- Acronym / sponsor ID
- RIFJPAR 12-01
- Conditions
- Total Hip Arthroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- First posted
- 29 Mar 2012 (estimated)
- 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 prospective, randomized study will study the 2 year survivorship and short term outcomes of a currently-used femoral stem: the Bone Preservation Tri-Lock femoral stem using two surgical approaches. The surgical approaches being studied are direct anterior and anterolateral. Implant survivorship, radiographic positioning, and functional outcomes will be compared. Subjects will be randomized to surgical approach and followed for a period of two years.
Study design
- Primary purpose
- Treatment
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Hip Arthroplasty performed via direct anterior approach | Active comparator | Procedure: Total Hip Arthroplasty |
| Total Hip Arthroplasty using anterolateral approach | Active comparator | Procedure: Total Hip Arthroplasty |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient signed an IRB, study specific informed patient consent
- Patient is a male or non-pregnant female age 21 years or older at the time of study device implantation
- Patient has primary diagnosis of non-inflammatory degenerative joint disease.
- Patient is a candidate for primary cementless total hip replacement
- Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Key exclusion criteria (5 listed)
- Patient has a Body Mass Index (BMI) > 40 Kg/m2
- Patient has an active or suspected infection at the time of device implantation
- Patient is immunologically suppressed.
- Patient requires revision surgery of a previously implanted total hip replacement
- Patient has a known sensitivity to device materials
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 |
|---|---|---|
| Total Hip Arthroplasty | Procedure or surgery | Total Hip Arthroplasty performed via direct anterior approach, Total Hip Arthroplasty using anterolateral approach |
Primary outcome
Survivorship of Bone Preservation Tri-Lock femoral stem
Time frame: 2 years post-op
Survivorship will be assessed via radiographic (x-ray) analysis and need for revision surgery (if patient had femoral stem removed for any reason within the first two years after surgery).
1 secondary outcome
TUG (timed up and go) Score
Time frame: 6 weeks post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2014.
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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. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Hip Arthroplasty in people with Total Hip Arthroplasty, run by Rothman Institute Orthopaedics at 2 sites 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 12 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tiffany Morrison, MS, CCRP (267-339-7818, tiffany.morrison@rothmaninstitute.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survivorship of Bone Preservation Tri-Lock femoral stem (time frame: 2 years post-op). 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 12 Feb 2014; AzTrials last refreshed its copy on 6 Nov 2026.