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

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

Study Overview

• Status: Completed
• Conditions: Hip Arthritis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 210

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • Chu de Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who received a first-line PTH between 2007 and 2012,

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rate	The main outcome measured was the survival of the implant	It was measured in October 2021

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Hoel Letissier, MD, Chu de Brest

Publications and helpful links

General Publications

• Batailler C, Fary C, Servien E, Lustig S. Influence of femoral broach shape on stem alignment using anterior approach for total hip arthroplasty: A radiologic comparative study of 3 different stems. PLoS One. 2018 Oct 5;13(10):e0204591. doi: 10.1371/journal.pone.0204591. eCollection 2018.
• Murphy CG, Bonnin MP, Desbiolles AH, Carrillon Y, Asmall yi, Ukrainiant Si Selmi T. Varus will have varus; a radiological study to assess and predict varus stem placement in uncemented femoral stems. Hip Int. 2016 Nov 10;26(6):554-560. doi: 10.5301/hipint.5000412. Epub 2016 Oct 15.
• Fottner A, Woiczinski M, Kistler M, Schroder C, Schmidutz TF, Jansson V, Schmidutz F. Varus malalignment of cementless hip stems provides sufficient primary stability but highly increases distal strain distribution. Clin Biomech (Bristol, Avon). 2018 Oct;58:14-20. doi: 10.1016/j.clinbiomech.2018.07.006. Epub 2018 Jul 5.

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2022
• Primary Completion (Actual): May 16, 2022
• Study Completion (Actual): May 16, 2022

Study Registration Dates

• First Submitted: May 17, 2022
• First Submitted That Met QC Criteria: June 29, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Actual): July 5, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: PTHVarus ( 29BRC22.0081)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No