Total Hip Arthroplasty Using Small Direct Anterior Incision: The Role of Short Femoral Stem
1 other identifier
interventional
N/A
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2012
CompletedFirst Posted
Study publicly available on registry
June 7, 2012
CompletedApril 9, 2013
April 1, 2013
June 4, 2012
April 8, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Short term hip function
Early functional outcome will be measured using the modified Harris Hip score at the first post-operative visit
within six weeks post-operative
Secondary Outcomes (1)
Short-Term Pain Levels of direct anterior and anterolateral surgical approaches
Study Arms (2)
Total Hip Arthroplasty using Fitmore femoral stem
ACTIVE COMPARATORTotal Hip Arthroplasty using M/L Taper Femoral stem
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Rothman Institute at AtlantiCare
Egg Harbor, New Jersey, 08234, United States
Rothman Institute at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2012
First Posted
June 7, 2012
Last Updated
April 9, 2013
Record last verified: 2013-04