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Clinical Trials/NCT01614028
NCT01614028
Unknown
Not Applicable

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

Rothman Institute Orthopaedics2 sites in 1 countryJune 7, 2012
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ConditionsTotal Hip Arthroplasty

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Total Hip Arthroplasty
Sponsor
Rothman Institute Orthopaedics
Locations
2
Primary Endpoint
Short term hip function
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 7, 2012
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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/m
  • •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.

Outcomes

Primary Outcomes

Short term hip function

Time Frame: within six weeks post-operative

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

Secondary Outcomes

  • Short-Term Pain Levels of direct anterior and anterolateral surgical approaches

Study Sites (2)

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