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

Total Hip Arthroplasty Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01566916
• Other study ID #: RIFJPAR 12-01
• Status: Not yet recruiting
• Phase: N/A
• First received: February 24, 2012
• Last updated: February 10, 2014

Study information

• Verified date: February 2014
• Source: Rothman Institute Orthopaedics
• Contact: Tiffany Morrison, MS, CCRP
• Phone: 267-339-7818
• Email: tiffany.morrison[@]rothmaninstitute.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Total Hip Arthroplasty

Intervention

Procedure:
• Total Hip Arthroplasty

Locations

Country	Name	City	State
United States	Rothman Institute	Egg Harbor Township	New Jersey
United States	Rothman Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survivorship of Bone Preservation Tri-Lock femoral stem	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).	2 years post-op
Secondary	TUG (timed up and go) Score		6 weeks post-op	No