Medium Term Survivorship of Cementless THA Performed Using the Bone Preservation Tri-Lock Femoral Stem
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ClinicalTrials.gov Identifier: NCT01566916
Verified February 2014 by Rothman Institute Orthopaedics. Recruitment status was: Not yet recruiting
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.
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Ages Eligible for Study:
21 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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