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

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.

Study Overview

• Status: Unknown
• Conditions: Total Hip Arthroplasty
• Intervention / Treatment: Procedure: Total Hip Arthoplasty

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short term hip function	Early functional outcome will be measured using the modified Harris Hip score at the first post-operative visit	within six weeks post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description
Short-Term Pain Levels of direct anterior and anterolateral surgical approaches	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

Collaborators and Investigators

• Sponsor: Rothman Institute Orthopaedics

Study record dates

Study Registration Dates

• First Submitted: June 4, 2012
• First Submitted That Met QC Criteria: June 5, 2012
• First Posted (Estimate): June 7, 2012

Study Record Updates

• Last Update Posted (Estimate): April 9, 2013
• Last Update Submitted That Met QC Criteria: April 8, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: JP2012-01