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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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
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, see Learn About Clinical Studies.

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 July 20, 2014