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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by Rothman Institute Orthopaedics.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01566916
First Posted: March 29, 2012
Last Update Posted: February 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rothman Institute Orthopaedics
February 24, 2012
March 29, 2012
February 12, 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 ]
Same as current
Not Provided
Not Provided
 
Medium Term Survivorship of Cementless THA Performed Using the Bone Preservation Tri-Lock Femoral Stem
Not Provided
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.
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
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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
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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