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Total Hip Arthroplasty Using Small Direct Anterior Incision: The Role of Short Femoral Stem

This study is currently recruiting participants.
Verified April 2013 by Rothman Institute Orthopaedics
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier:
NCT01614028
First received: June 4, 2012
Last updated: April 8, 2013
Last verified: April 2013
History of Changes
  Purpose

This study aims to investigate short-term outcomes following the use of two femoral stems used during Total Hip arthoplasty: the Fitmore Femoral stem and the M/L Taper Femoral stem.


Condition Intervention
Total Hip Arthroplasty
 Procedure: Total Hip Arthoplasty

Study Type: Interventional

Further study details as provided by Rothman Institute Orthopaedics:

Primary Outcome Measures:
  • Short term hip function [ Time Frame: within six weeks post-operative ] [ Designated as safety issue: No ]
    Early functional outcome will be measured using the modified Harris Hip score at the first post-operative visit


Secondary Outcome Measures:
  • Short-Term Pain Levels of direct anterior and anterolateral surgical approaches [ Designated as safety issue: No ]
    Short-term (6 weeks post-op) pain will also be compared between the approach used for the total hip replacement: namely direct anterior and anterolateral using a VAS pain scale


Arms Assigned Interventions
Active Comparator: Total Hip Arthroplasty using Fitmore femoral stem Procedure: Total Hip Arthoplasty
Active Comparator: Total Hip Arthroplasty using M/L Taper Femoral stem Procedure: Total Hip Arthoplasty

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 18 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01614028

Locations
United States, New Jersey
Rothman Institute at AtlantiCare Recruiting
Egg Harbor Township, New Jersey, United States, 08234
Contact: Anne Marie Madden, CCRP     609-407-6446        
Sub-Investigator: Zachary Post, MD            
Sub-Investigator: Alvin Ong, MD            
Sub-Investigator: Fabio Orozco, MD            
United States, Pennsylvania
Rothman Institute at Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Tiffany Morrison, MS, CCRP     267-339-7818        
Principal Investigator: Gregory Deirmengian, MD            
Sub-Investigator: Javad Parvizi, MD            
Sponsors and Collaborators
Rothman Institute Orthopaedics
  More Information

No publications provided

Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT01614028     History of Changes
Other Study ID Numbers: JP2012-01
Study First Received: June 4, 2012
Last Updated: April 8, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 23, 2013