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

Not Applicable

• Conditions: Total Hip Arthroplasty
• Interventions: Procedure: Total Hip Arthroplasty

• Registration Number: NCT01566916
• Lead Sponsor: Rothman Institute Orthopaedics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-24
• Study First Submitted QC: 2012-03-27
• Study First Posted: 2012-03-29
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-10
• Last Update Posted: 2014-02-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Total Hip Arthroplasty performed via direct anterior approach	Total Hip Arthroplasty	-
Total Hip Arthroplasty using anterolateral approach	Total Hip Arthroplasty	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
TUG (timed up and go) Score	6 weeks post-op

Trial Locations

Locations (1)

Rothman Institute; 🇺🇸 Philadelphia, Pennsylvania, United States