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

Hip Arthritis Clinical Trial

— PTHVarus  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05443243
• Other study ID #: PTHVarus ( 29BRC22.0081)
• Status: Completed
• Start date: May 13, 2022
• Est. completion date: May 16, 2022

Study information

• Verified date: April 2022
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: May 16, 2022
• Est. primary completion date: May 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Hip Arthritis

Intervention

Procedure:
• Total Hip Arthroplasty
Patient were operated, a Total hip arthroplasty was performed

Locations

Country	Name	City	State
France	CHU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

References & Publications (3)

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/journ — View Citation

Fottner A, Woiczinski M, Kistler M, Schröder 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; — View Citation

Murphy CG, Bonnin MP, Desbiolles AH, Carrillon Y, A?t 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 201 — View Citation

Outcome

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