CClinicalTrials.gg
Sign In
Status unknownNCT01614028Updated Apr 9, 2013

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

An interventional study of Total Hip Arthoplasty in Total Hip Arthroplasty, sponsored by Rothman Institute Orthopaedics. Status unknown at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-04-09.

Sponsored by Rothman Institute Orthopaedics · Not applicable and Interventional

The sponsor has not verified this record recently (last verified Apr 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Total Hip Arthroplasty
03

In context

Lead sponsor

Rothman Institute Orthopaedics is the lead sponsor of 118 studies on the registry; 17 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable

Study arms

  • 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

Interventions

  • ProcedureTotal Hip Arthoplasty
06

What researchers measure

Primary outcomes

  1. Short term hip function

    Early functional outcome will be measured using the modified Harris Hip score at the first post-operative visit

    Time frame: within six weeks post-operative

Secondary outcomes

  1. 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

07

Study locations

2 of 2 sites recruiting
  • Rothman Institute at AtlantiCare
    Egg Harbor Township, New Jersey 08234, United States
    • Anne Marie Madden, CCRP · Contact · 609-407-6446
    • Zachary Post, MD · Sub investigator
    • Alvin Ong, MD · Sub investigator
    • Fabio Orozco, MD · Sub investigator
    Recruiting
  • Rothman Institute at Thomas Jefferson University
    Philadelphia, Pennsylvania 19107, United States
    • Tiffany Morrison, MS, CCRP · Contact · 267-339-7818
    • Gregory Deirmengian, MD · Principal investigator
    • Javad Parvizi, MD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01614028
Lead sponsor
Rothman Institute Orthopaedics
Responsible party
Sponsor
First posted
Jun 7, 2012
Last update
Apr 9, 2013
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Rothman Institute Orthopaedics

Start the discussion