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

Not Applicable

• Conditions: Total Hip Arthroplasty
• Interventions: Procedure: Total Hip Arthoplasty

• Registration Number: NCT01614028
• Lead Sponsor: Rothman Institute Orthopaedics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-04
• Study First Submitted QC: 2012-06-05
• Study First Posted: 2012-06-07
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-08
• Last Update Posted: 2013-04-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Total Hip Arthroplasty using Fitmore femoral stem	Total Hip Arthoplasty	-
Total Hip Arthroplasty using M/L Taper Femoral stem	Total Hip Arthoplasty	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Rothman Institute at AtlantiCare; 🇺🇸 Egg Harbor Township, New Jersey, United States

Rothman Institute at Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States