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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
  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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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


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

Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT01566916     History of Changes
Other Study ID Numbers: RIFJPAR 12-01
First Submitted: February 24, 2012
First Posted: March 29, 2012
Last Update Posted: February 12, 2014
Last Verified: February 2014