Total Hip ArthroplastyNCT01614028
Total Hip Arthroplasty Using Small Direct Anterior Incision: The Role of Short Femoral Stem
A study testing Total Hip Arthoplasty in people with Total Hip Arthroplasty, run by Rothman Institute Orthopaedics at 2 sites in United States.
Trial summary
This study aims to investigate short-term outcomes following the use of two femoral stems used during Total Hip arthoplasty: the Fitmore Femoral stem and the M/L Taper Femoral stem. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- Total Hip Arthoplasty
- 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 18 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 18 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, 2 recruiting
- Recruiting
Rothman Institute at AtlantiCare
Egg Harbor, New Jersey, 08234
Anne Marie Madden, CCRP, 609-407-6446
Zachary Post, MD
- Recruiting
Rothman Institute at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Tiffany Morrison, MS, CCRP, 267-339-7818
Gregory Deirmengian, MD
About this study
This study aims to investigate short-term outcomes following the use of two femoral stems used during Total Hip arthoplasty: the Fitmore Femoral stem and the M/L Taper Femoral stem.
- Conditions
- Total Hip Arthroplasty
- Being tested
- Total Hip Arthoplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip ArthoplastyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Total Hip Arthroplasty using Fitmore femoral stem | Active comparator | Not described Receives: Procedure: Total Hip Arthoplasty |
| Total Hip Arthroplasty using M/L Taper Femoral stem | Active comparator | Not described Receives: Procedure: Total Hip Arthoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short term hip function
Early functional outcome will be measured using the modified Harris Hip score at the first post-operative visit
Measured: within six weeks post-operative
Secondary outcomes (1)
Short-Term Pain Levels of direct anterior and anterolateral surgical approaches
Short-term (6 weeks post-op) pain will also be compared between the approach used for the total hip replacement: namely direct anterior and anterolateral using a VAS pain scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 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
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01614028
- Sponsor's protocol ID
- JP2012-01
- Status last verified
- Apr 2013
- First submitted
- 4 Jun 2012
- Last updated
- 9 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Hip Arthroplasty Using Small Direct Anterior Incision: The Role of Short Femoral Stem
- ClinicalTrials.gov ID
- NCT01614028
- Acronym / sponsor ID
- JP2012-01
- Conditions
- Total Hip Arthroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- First posted
- 7 Jun 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 study aims to investigate short-term outcomes following the use of two femoral stems used during Total Hip arthoplasty: the Fitmore Femoral stem and the M/L Taper Femoral stem.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Hip Arthroplasty using Fitmore femoral stem | Active comparator | Procedure: Total Hip Arthoplasty |
| Total Hip Arthroplasty using M/L Taper Femoral stem | Active comparator | Procedure: Total Hip Arthoplasty |
Who may qualify
- Ages
- 18 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 18 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 Arthoplasty | Procedure or surgery | Total Hip Arthroplasty using Fitmore femoral stem, Total Hip Arthroplasty using M/L Taper Femoral stem |
Primary outcome
Short term hip function
Time frame: within six weeks post-operative
Early functional outcome will be measured using the modified Harris Hip score at the first post-operative visit
1 secondary outcome
Short-Term Pain Levels of direct anterior and anterolateral surgical approaches
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2013.
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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 Arthoplasty 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 9 Apr 2013. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short term hip function (time frame: within six weeks post-operative). 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 9 Apr 2013.