Fully Disposable Patient-Specific Instrumentation
MyKnee
Primary TKA Using a Fully Disposable Patient-Specific Instrumentation: A Multicenter Controlled Study
1 other identifier
interventional
210
0 countries
N/A
Brief Summary
To evaluate the lower limb alignment following total knee arthroplasty (TKA) performed with fully disposable patient-specific instrumentation versus conventional, versus patient specific instrumentation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2013
Typical duration for not_applicable
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
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 26, 2016
CompletedFirst Posted
Study publicly available on registry
November 17, 2016
CompletedNovember 17, 2016
November 1, 2016
2.2 years
September 26, 2016
November 15, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
HKA angle
Lower limb mechanical axis was measured on a bipodal standing leg-length anteroposterior radiograph with the patella oriented straight made three months postoperatively, using Roman software version 1.70 (Oswestry, United Kingdom). Postoperative lower limb mechanical axis was calculated from the Hip-Knee-Ankle (HKA) angle between the femoral and tibial mechanical axes, respectively. An HKA angle greater than 180° was indicative of valgus, whereas values lower than 180° indicated varus.
3 months
Secondary Outcomes (3)
% outliers
3 months
Knee Society Score
3 months
Oxford Knee Score
3 months
Study Arms (3)
CI
ACTIVE COMPARATORTKA using conventional instrumentation (CI)
PSCG
EXPERIMENTALTKA performed using Patient specific cutting guides (PSCG)
PSCG-D
EXPERIMENTALTKA performed using fully disposable Patient specific cutting guides (PSCG-D)
Interventions
Eligibility Criteria
You may qualify if:
- patients aged between 18 and 85 years
- able to understand information
- affiliated to social security
You may not qualify if:
- active or suspected sepsis
- tumor around the knee
- previous partial or total knee replacement
- extra-articular deformation requiring osteotomy around the knee in conjunction with TKA
- social situation that could impair follow-up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cochin Hospitallead
Related Publications (1)
Abane L, Zaoui A, Anract P, Lefevre N, Herman S, Hamadouche M. Can a Single-Use and Patient-Specific Instrumentation Be Reliably Used in Primary Total Knee Arthroplasty? A Multicenter Controlled Study. J Arthroplasty. 2018 Jul;33(7):2111-2118. doi: 10.1016/j.arth.2018.02.038. Epub 2018 Feb 17.
PMID: 29576488DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- AMBIG
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, Professor of Orthopaedic Surgery
Study Record Dates
First Submitted
September 26, 2016
First Posted
November 17, 2016
Study Start
September 1, 2013
Primary Completion
December 1, 2015
Study Completion
September 1, 2016
Last Updated
November 17, 2016
Record last verified: 2016-11