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

This study is not yet open for participant recruitment.
Verified April 2013 by Rothman Institute Orthopaedics
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier:
NCT01566916
First received: February 24, 2012
Last updated: April 8, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Total Hip Arthroplasty
 Procedure: Total Hip Arthroplasty

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Further study details as provided by Rothman Institute Orthopaedics:

Primary Outcome Measures:
  • Survivorship of Bone Preservation Tri-Lock femoral stem [ Time Frame: 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:
  • TUG (timed up and go) Score [ Time Frame: 6 weeks post-op ] [ Designated as safety issue: No ]

Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566916

Contacts
Contact: Tiffany Morrison, MS, CCRP 267-339-7818 tiffany.morrison@rothmaninstitute.com

Locations
United States, New Jersey
Rothman Institute Not yet recruiting
Egg Harbor Township, New Jersey, United States, 08234
United States, Pennsylvania
Rothman Institute Not yet recruiting
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Rothman Institute Orthopaedics
  More Information

No publications provided

Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT01566916     History of Changes
Other Study ID Numbers: RIFJPAR 12-01
Study First Received: February 24, 2012
Last Updated: April 8, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 23, 2013