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Clinical Trials/NCT05443243
NCT05443243CompletedNot Applicable

Is a THA Stem in Varus a Risk Factor of Long-term Mechanical Complication

University Hospital, Brest1 site in 1 country210 target enrollmentStarted: May 13, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
210
Locations
1
Primary Endpoint
Survival rate

Study Overview

Brief Summary

The objective of this study is to compare the long-term survival as well as the functional and radiographic results of the rods in the alignment of the varus to the stems in the neutral alignment by comparing 2 groups of implanted Total Hip Arthroplasty. 1 group of stems implanted in varus position. 1 group of stems implanted in neutral position

Detailed Description

ABSTRACT:

Introduction

Femoral stem positioning in the frontal plane has always been considered a fundamental criterion for implant survival and for functional and radiographic outcomes in total hip arthroplasty (THA). The impact of implanting cementless femoral stems in varus alignment on long-term mechanical complications remains poorly defined in the literature. The aim of our study is to compare long-term survivorship as well as functional and radiographic outcomes of stems in varus alignment to stems in neutral alignment.

Patients and Methods: This single center, multi-surgeon, retrospective case-control study will compare a group of 105 THA patients with varus stem alignment (VS) to a control group of 105 THA patients with neutral stem alignment (NS), operated in Brest center between January 2007 and December 2012. The primary outcome measure is implant survival. Secondary outcomes include functional outcomes: HHS, PMA, thigh pain, dislocation and hip ROM; and radiographic outcomes: radiolucency, Agora Roentgenography Assessment (ARA) score, osseointegration, heterotopic ossification, subsidence and stress shielding.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • PTH rod implanted in varus,
  • Having X-rays and clinical data in their file
  • Within a period of less than 6 months
  • No opposition

Exclusion Criteria

  • PTH in a context of fracture of the femoral neck
  • PTH 2nd intention
  • Lost to sight
  • Patients who died within 6 months
  • Refusal to participate

Outcomes

Primary Outcomes

Survival rate

Time Frame: It was measured in October 2021

The main outcome measured was the survival of the implant

Secondary Outcomes

  • Thigh pain(It was measured in October 2021)
  • PMA score :(It was measured in October 2021)
  • HHS(It was measured in October 2021)
  • Hip ROM(It was measured in October 2021)
  • Osseointegration(It was measured in October 2021)
  • Dislocation(It was measured in October 2021)
  • Radiolucency(It was measured in October 2021)
  • Agora Roentgenography Assessment (ARA) score(It was measured in October 2021)
  • Stress shielding.(t was measured in October 2021)
  • Heterotopic ossification(t was measured in October 2021)
  • Subsidence(t was measured in October 2021)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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