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Completed

NCT Number: NCT05443243

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

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

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Key information

Conditions

Hip Arthritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Brest

Brest, 29609, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total Hip Arthroplasty

Procedure

Patient were operated, a Total hip arthroplasty was performed

Primary outcomes

  1. Survival rate

    Time frame: It was measured in October 2021

    The main outcome measured was the survival of the implant

Secondary outcomes

  1. HHS

    Time frame: It was measured in October 2021

    Functional outcome : - The Harris Hip Score (HHS) [26] which assesses pain, function, deformity and range of motion (ROM) with a maximum score of 100

  2. PMA score :

    Time frame: It was measured in October 2021

    Functional outcome : which assesses pain, gait and mobility with a maximum score of 18

  3. Thigh pain

    Time frame: It was measured in October 2021

    Functional outcome : we measured the rate of patients experiencing pain at the level of the thigh

  4. Dislocation

    Time frame: It was measured in October 2021

    Functional outcome : hip disclocation rate over the follow up period

  5. Hip ROM

    Time frame: It was measured in October 2021

    Functional outcome : Hip range of motion in flexion, adduction, extension, abduction and rotations

  6. Radiolucency

    Time frame: It was measured in October 2021

    Radiographic outcome : - Radiolucency according to the Gruen/Callaghan zones

  7. Agora Roentgenography Assessment (ARA) score

    Time frame: It was measured in October 2021

    Radiographic outcome : - Agora Roentgenography Assessment (ARA) score for cementless femoral stem stability according to Epinette

  8. Osseointegration

    Time frame: It was measured in October 2021

    Radiographic outcome mesured was described in "Roentgenographic assessment of the biologic fixation of porous-surfaced femoral components" Engh CA, Massin P, Suthers KE"

  9. Heterotopic ossification

    Time frame: t was measured in October 2021

    Radiographic outcome : - Brooker classification of heterotopic ossification

  10. Subsidence

    Time frame: t was measured in October 2021

    Radiographic outcome : - Subsidence: considered significant if more than 5 mm between the immediate postoperative x-ray and the last follow-up x-ray. Subsidence was assessed by measuring the distance between the tip of the trochanter and the "shoulder" of the stem

  11. Stress shielding.

    Time frame: t was measured in October 2021

    Radiographic outcome : we measured the rate of patients with Xray showing stress shielding signs

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: PTHVarus

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 5, 2022
Registry last updated
Jul 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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