Is a THA Stem in Varus a Risk Factor of Long-term Mechanical Complication
PTHVarus
1 other identifier
observational
210
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 16, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 16, 2022
CompletedFirst Submitted
Initial submission to the registry
May 17, 2022
CompletedFirst Posted
Study publicly available on registry
July 5, 2022
CompletedJuly 5, 2022
April 1, 2022
3 days
May 17, 2022
June 29, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Survival rate
The main outcome measured was the survival of the implant
It was measured in October 2021
Secondary Outcomes (11)
HHS
It was measured in October 2021
PMA score :
It was measured in October 2021
Thigh pain
It was measured in October 2021
Dislocation
It was measured in October 2021
Hip ROM
It was measured in October 2021
- +6 more secondary outcomes
Study Arms (2)
Varus Stems
Patients with a THA Stem implanted in Varus position
Neutral stems
Patients with a THA Stem implanted in Neutral position
Interventions
Patient were operated, a Total hip arthroplasty was performed
Eligibility Criteria
Patients who received a first-line PTH between 2007 and 2012,
You may qualify if:
- PTH rod implanted in varus,
- Having X-rays and clinical data in their file
- Within a period of less than 6 months
- No opposition
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Brest
Brest, 29609, France
Related 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/journal.pone.0204591. eCollection 2018.
PMID: 30289882RESULTMurphy 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.
PMID: 27768218RESULTFottner 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.
PMID: 30005422RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hoel Letissier, MD
CHU de Brest
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2022
First Posted
July 5, 2022
Study Start
May 13, 2022
Primary Completion
May 16, 2022
Study Completion
May 16, 2022
Last Updated
July 5, 2022
Record last verified: 2022-04