Medium Term Survivorship of Cementless THA Performed Using the Bone Preservation Tri-Lock Femoral Stem

Status unconfirmed · Not applicable

Conditions studied: Total Hip Arthroplasty

In brief

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.

Key facts

Study ID

NCT01566916

Run by

Rothman Institute Orthopaedics

Last updated by the study team

2014-02-12

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Rothman Institute — Egg Harbor, New Jersey, United States
• Rothman Institute — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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