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

Sponsor
University Hospital, Brest (Other)
Overall Status
Completed
CT.gov ID
NCT05443243
Collaborator
(none)
210
1
3
2130.6

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Total Hip Arthroplasty

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
Actual Enrollment :
210 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Is a THA Stem in Varus a Risk Factor of Long-term Mechanical Complication
Actual Study Start Date :
May 13, 2022
Actual Primary Completion Date :
May 16, 2022
Actual Study Completion Date :
May 16, 2022

Arms and Interventions

Arm Intervention/Treatment
Varus Stems

Patients with a THA Stem implanted in Varus position

Procedure: Total Hip Arthroplasty
Patient were operated, a Total hip arthroplasty was performed

Neutral stems

Patients with a THA Stem implanted in Neutral position

Procedure: Total Hip Arthroplasty
Patient were operated, a Total hip arthroplasty was performed

Outcome Measures

Primary Outcome Measures

  1. Survival rate [It was measured in October 2021]

    The main outcome measured was the survival of the implant

Secondary Outcome Measures

  1. HHS [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 : [It was measured in October 2021]

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

  3. Thigh pain [It was measured in October 2021]

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

  4. Dislocation [It was measured in October 2021]

    Functional outcome : hip disclocation rate over the follow up period

  5. Hip ROM [It was measured in October 2021]

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

  6. Radiolucency [It was measured in October 2021]

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

  7. Agora Roentgenography Assessment (ARA) score [It was measured in October 2021]

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

  8. Osseointegration [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 [t was measured in October 2021]

    Radiographic outcome : - Brooker classification of heterotopic ossification

  10. Subsidence [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. [t was measured in October 2021]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Brest Brest France 29609

Sponsors and Collaborators

  • University Hospital, Brest

Investigators

  • Principal Investigator: Hoel Letissier, MD, CHU de Brest

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT05443243
Other Study ID Numbers:
  • PTHVarus ( 29BRC22.0081)
First Posted:
Jul 5, 2022
Last Update Posted:
Jul 5, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 5, 2022