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

Completed

• Conditions: Hip Arthritis
• Interventions: Procedure: Total Hip Arthroplasty

• Registration Number: NCT05443243
• Lead Sponsor: University Hospital, Brest

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 Timeline

• Status Verified: 2022-04
• Study Start: 2022-05-13
• Primary Completion: 2022-05-16
• Study Completion: 2022-05-16
• Study First Submitted: 2022-05-17
• Study First Submitted QC: 2022-06-29
• Last Update Submitted: 2022-06-29
• Study First Posted: 2022-07-05
• Last Update Posted: 2022-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neutral stems	Total Hip Arthroplasty	Patients with a THA Stem implanted in Neutral position
Varus Stems	Total Hip Arthroplasty	Patients with a THA Stem implanted in Varus position

Primary Outcome Measures

Name	Time	Method
Survival rate	It was measured in October 2021	The main outcome measured was the survival of the implant

Secondary Outcome Measures

Name	Time	Method
PMA score :	It was measured in October 2021	Functional outcome : which assesses pain, gait and mobility with a maximum score of 18
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
Thigh pain	It was measured in October 2021	Functional outcome : we measured the rate of patients experiencing pain at the level of the thigh
Hip ROM	It was measured in October 2021	Functional outcome : Hip range of motion in flexion, adduction, extension, abduction and rotations
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"
Dislocation	It was measured in October 2021	Functional outcome : hip disclocation rate over the follow up period
Radiolucency	It was measured in October 2021	Radiographic outcome : - Radiolucency according to the Gruen/Callaghan zones
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
Stress shielding.	t was measured in October 2021	Radiographic outcome : we measured the rate of patients with Xray showing stress shielding signs
Heterotopic ossification	t was measured in October 2021	Radiographic outcome : - Brooker classification of heterotopic ossification
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

Trial Locations

Locations (1)

CHU de Brest; 🇫🇷 Brest, France