Total Hip Arthroplasty
Conditions
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.
Interventions
PROCEDURETotal Hip Arthroplasty
Sponsors
Rothman Institute Orthopaedics
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survivorship of Bone Preservation Tri-Lock femoral stem | 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). |
Secondary
| Measure | Time frame |
|---|---|
| TUG (timed up and go) Score | 6 weeks post-op |
Countries
United States
Contacts
Primary ContactTiffany Morrison, MS, CCRP
Outcome results
None listed