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

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.

Study Overview

• Status: Unknown
• Conditions: Total Hip Arthroplasty
• Intervention / Treatment: Procedure: Total Hip Arthroplasty

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Egg Harbor Township, New Jersey, United States, 08234
      • Rothman Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Total Hip Arthroplasty performed via direct anterior approach	Procedure: Total Hip Arthroplasty
Active Comparator: Total Hip Arthroplasty using anterolateral approach	Procedure: Total Hip Arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
TUG (timed up and go) Score	6 weeks post-op

Collaborators and Investigators

• Sponsor: Rothman Institute Orthopaedics

Study record dates

Study Registration Dates

• First Submitted: February 24, 2012
• First Submitted That Met QC Criteria: March 27, 2012
• First Posted (Estimate): March 29, 2012

Study Record Updates

• Last Update Posted (Estimate): February 12, 2014
• Last Update Submitted That Met QC Criteria: February 10, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: RIFJPAR 12-01