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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Rothman Institute Orthopaedics
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier:
NCT01566916
First received: February 24, 2012
Last updated: February 10, 2014
Last verified: February 2014

February 24, 2012
February 10, 2014
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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).
Same as current
Complete list of historical versions of study NCT01566916 on ClinicalTrials.gov Archive Site
TUG (timed up and go) Score [ Time Frame: 6 weeks post-op ] [ Designated as safety issue: No ]
Same as current
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Medium Term Survivorship of Cementless THA Performed Using the Bone Preservation Tri-Lock Femoral Stem
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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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Interventional
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Primary Purpose: Treatment
Total Hip Arthroplasty
Procedure: Total Hip Arthroplasty
  • Active Comparator: Total Hip Arthroplasty performed via direct anterior approach
    Intervention: Procedure: Total Hip Arthroplasty
  • Active Comparator: Total Hip Arthroplasty using anterolateral approach
    Intervention: Procedure: Total Hip Arthroplasty
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
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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
Both
21 Years and older
No
Contact: Tiffany Morrison, MS, CCRP 267-339-7818 tiffany.morrison@rothmaninstitute.com
United States
 
NCT01566916
RIFJPAR 12-01
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Rothman Institute Orthopaedics
Rothman Institute Orthopaedics
Not Provided
Not Provided
Rothman Institute Orthopaedics
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP