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

Total Hip Arthroplasty Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01614028
• Other study ID #: JP2012-01
• Status: Recruiting
• Phase: N/A
• First received: June 4, 2012
• Last updated: April 8, 2013

Study information

• Verified date: April 2013
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

N/A

Related Conditions & MeSH terms

• Total Hip Arthroplasty

Intervention

Procedure:
• Total Hip Arthoplasty

Locations

Country	Name	City	State
United States	Rothman Institute at AtlantiCare	Egg Harbor Township	New Jersey
United States	Rothman Institute at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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		No