Medium Term Survivorship of Cementless THA Performed Using the Bone Preservation Tri-Lock Femoral Stem
1 other identifier
interventional
N/A
1 country
2
Brief 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. 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.
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
February 24, 2012
CompletedFirst Posted
Study publicly available on registry
March 29, 2012
CompletedFebruary 12, 2014
February 1, 2014
February 24, 2012
February 10, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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).
2 years post-op
Secondary Outcomes (1)
TUG (timed up and go) Score
6 weeks post-op
Study Arms (2)
Total Hip Arthroplasty performed via direct anterior approach
ACTIVE COMPARATORTotal Hip Arthroplasty using anterolateral approach
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 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.
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
Egg Harbor, New Jersey, 08234, United States
Rothman Institute
Philadelphia, Pennsylvania, 19107, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2012
First Posted
March 29, 2012
Last Updated
February 12, 2014
Record last verified: 2014-02