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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05443243
Acronym
PTHVarus
Enrollment
210
Registered
2022-07-05
Start date
2022-05-13
Completion date
2022-05-16
Last updated
2022-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Arthritis

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.

Interventions

PROCEDURETotal Hip Arthroplasty

Patient were operated, a Total hip arthroplasty was performed

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Survival rateIt was measured in October 2021The main outcome measured was the survival of the implant

Secondary

MeasureTime frameDescription
PMA score :It was measured in October 2021Functional outcome : which assesses pain, gait and mobility with a maximum score of 18
Thigh painIt was measured in October 2021Functional outcome : we measured the rate of patients experiencing pain at the level of the thigh
DislocationIt was measured in October 2021Functional outcome : hip disclocation rate over the follow up period
Hip ROMIt was measured in October 2021Functional outcome : Hip range of motion in flexion, adduction, extension, abduction and rotations
RadiolucencyIt was measured in October 2021Radiographic outcome : - Radiolucency according to the Gruen/Callaghan zones
HHSIt was measured in October 2021Functional outcome : - The Harris Hip Score (HHS) \[26\] which assesses pain, function, deformity and range of motion (ROM) with a maximum score of 100
OsseointegrationIt was measured in October 2021Radiographic outcome mesured was described in Roentgenographic assessment of the biologic fixation of porous-surfaced femoral components Engh CA, Massin P, Suthers KE
Heterotopic ossificationt was measured in October 2021Radiographic outcome : - Brooker classification of heterotopic ossification
Subsidencet was measured in October 2021Radiographic 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
Stress shielding.t was measured in October 2021Radiographic outcome : we measured the rate of patients with Xray showing stress shielding signs
Agora Roentgenography Assessment (ARA) scoreIt was measured in October 2021Radiographic outcome : - Agora Roentgenography Assessment (ARA) score for cementless femoral stem stability according to Epinette

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026