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

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ClinicalTrials.gov Identifier: NCT01566916
Recruitment Status : Unknown
Verified February 2014 by Rothman Institute Orthopaedics.
Recruitment status was:  Not yet recruiting
First Posted : March 29, 2012
Last Update Posted : February 12, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Total Hip Arthroplasty Procedure: Total Hip Arthroplasty

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment

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

Primary Outcome Measures :
  1. 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 :
  1. TUG (timed up and go) Score [ Time Frame: 6 weeks post-op ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01566916

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

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

Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT01566916     History of Changes
Other Study ID Numbers: RIFJPAR 12-01
First Posted: March 29, 2012    Key Record Dates
Last Update Posted: February 12, 2014
Last Verified: February 2014