Clinical trial NCT05443243: Is a THA Stem in Varus a Risk Factor of Long-term Mechanical Complication
Official title: Is a THA Stem in Varus a Risk Factor of Long-term Mechanical Complication
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Arthritis
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who received a first-line PTH between 2007 and 2012,

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.

Eligibility criteria: 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

Primary outcomes:
measure: Survival rate
timeFrame: It was measured in October 2021
Secondary outcomes:
measure: HHS
timeFrame: It was measured in October 2021
measure: PMA score :
timeFrame: It was measured in October 2021
measure: Thigh pain
timeFrame: It was measured in October 2021
measure: Dislocation
timeFrame: It was measured in October 2021
measure: Hip ROM
timeFrame: It was measured in October 2021
measure: Radiolucency
timeFrame: It was measured in October 2021
measure: Agora Roentgenography Assessment (ARA) score
timeFrame: It was measured in October 2021
measure: Osseointegration
timeFrame: It was measured in October 2021
measure: Heterotopic ossification
timeFrame: t was measured in October 2021
measure: Subsidence
timeFrame: t was measured in October 2021
measure: Stress shielding.
timeFrame: t was measured in October 2021
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU de Brest
Study officials:
affiliation: CHU de Brest
name: Hoel Letissier, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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). 2018 Oct;58:14-20. doi: 10.1016/j.clinbiomech.2018.07.006. Epub 2018 Jul 5.