Recruiting

Fitmore & M/L Taper

Sponsor:

Rothman Institute Orthopaedics

Code:

NCT01614028

Conditions

Total Hip Arthroplasty

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Total Hip Arthoplasty

Study Details

Brief summary:

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.

Conditions

Total Hip Arthroplasty

Study ID

NCT01614028

Status verified date

Apr, 2013

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Interventions and Outcome Measures

Arms

active comparator: Total Hip Arthroplasty using Fitmore femoral stem

active comparator: Total Hip Arthroplasty using M/L Taper Femoral stem

Interventions

Total Hip Arthoplasty

Primary outcome measure

  • Short term hip function [ Time Frame: within six weeks post-operative ]

Central Contacts and Locations

Locations

Rothman Institute at AtlantiCare

Recruiting

Egg Harbor Township, New Jersey, United States, 08234

Contacts

Anne Marie Madden, CCRP

609-407-6446

Rothman Institute at Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Tiffany Morrison, MS, CCRP

267-339-7818

Principal Investigator:

Gregory Deirmengian, MD

More Information

Sponsor

Rothman Institute Orthopaedics

Last update posted

Apr 9, 2013

Last verified

Apr, 2013

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Rothman Institute Orthopaedics on 2013-04-09.