An observational study in Hip Arthritis, sponsored by University Hospital, Brest. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-05.
Sponsored by University Hospital, Brest · Observational
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
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.
University Hospital, Brest is the lead sponsor of 600 studies on the registry; 135 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who received a first-line PTH between 2007 and 2012,
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Exclusion Criteria:
Patients with a THA Stem implanted in Varus position
Procedure: Total Hip Arthroplasty
Patients with a THA Stem implanted in Neutral position
Procedure: Total Hip Arthroplasty
Patient were operated, a Total hip arthroplasty was performed
Survival rate
The main outcome measured was the survival of the implant
Time frame: It was measured in October 2021
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
Time frame: It was measured in October 2021
PMA score :
Functional outcome : which assesses pain, gait and mobility with a maximum score of 18
Time frame: It was measured in October 2021
Thigh pain
Functional outcome : we measured the rate of patients experiencing pain at the level of the thigh
Time frame: It was measured in October 2021
Dislocation
Functional outcome : hip disclocation rate over the follow up period
Time frame: It was measured in October 2021
Hip ROM
Functional outcome : Hip range of motion in flexion, adduction, extension, abduction and rotations
Time frame: It was measured in October 2021
Radiolucency
Radiographic outcome : - Radiolucency according to the Gruen/Callaghan zones
Time frame: 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
Time frame: 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"
Time frame: It was measured in October 2021
Heterotopic ossification
Radiographic outcome : - Brooker classification of heterotopic ossification
Time frame: 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
Time frame: t was measured in October 2021
Stress shielding.
Radiographic outcome : we measured the rate of patients with Xray showing stress shielding signs
Time frame: t was measured in October 2021
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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