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

R

Regional University Hospital Center (CHRU)

Status

Completed

Conditions

Hip Arthritis

Treatments

Procedure: Total Hip Arthroplasty

Study type

Observational

Funder types

Other

Identifiers

NCT05443243
PTHVarus ( 29BRC22.0081)

Details and patient eligibility

About

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

Full 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.

Enrollment

210 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

210 participants in 2 patient groups

Varus Stems
Description:
Patients with a THA Stem implanted in Varus position
Treatment:
Procedure: Total Hip Arthroplasty
Neutral stems
Description:
Patients with a THA Stem implanted in Neutral position
Treatment:
Procedure: Total Hip Arthroplasty

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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