Comparison of Vibration Arthrometry Between Patella Resurfacing and Patella Non-resurfacing in Total Knee Replacement Patients
Prospective Randomized Controlled Trial: Comparison of Vibration Arthrometry Between Patella Resurfacing and Patella Non-resurfacing in Total Knee Replacement Patients
1 other identifier
interventional
102
1 country
1
Brief Summary
Patellar crepitus is a complication of total knee arthroplasty (TKA).The development of patellar crepitus after TKA are related to many factors such as femoral component design, surgical errors, and postoperative patellar baja. However, it is unclear whether patella resurfacing or patella non-resurfacing are associate with patellar crepitus. The primary objective of this study are to compare the prevalence of patellar crepitus and the mean value of vibroacoustic signal between patellar-resurfacing and patellar non-resurfacing in TKA. The secondary objective is to study the association between patellar crepitus and vibroacoustic signal.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2016
Typical duration for not_applicable
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
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 10, 2016
CompletedFirst Posted
Study publicly available on registry
December 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedJanuary 7, 2019
January 1, 2019
2 years
December 10, 2016
January 4, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
change of patellar crepitus
patellar crepitus investigate by physical examination
pre-op, 3, 6 month
change of mean of vibroacoustic signal
pre-op, 3, 6 month
Secondary Outcomes (1)
Number of patellar crepitus related to mean of vibroacoustic signal
pre-op, 3, 6 month
Study Arms (2)
patellar resurfacing
EXPERIMENTALpatellar resurfacing TKA
patellar non-resurfacing
NO INTERVENTIONpatellar non-resurfacing TKA
Interventions
Eligibility Criteria
You may qualify if:
- primary osteoarthritis of knee
You may not qualify if:
- rheumatoid arthritis
- morbid obesity
- severe patellofemoral joint destruction
- patella maltracking
- patellofemoral incongruent
- inflammatory arthritis
- refuse to participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Navamindradhiraj University
Dusit, Bangkok, 10300, Thailand
Related Publications (2)
Baczkowicz D, Majorczyk E. Joint motion quality in vibroacoustic signal analysis for patients with patellofemoral joint disorders. BMC Musculoskelet Disord. 2014 Dec 12;15:426. doi: 10.1186/1471-2474-15-426.
PMID: 25496721BACKGROUNDTanaka N, Hoshiyama M. Vibroarthrography in patients with knee arthropathy. J Back Musculoskelet Rehabil. 2012;25(2):117-22. doi: 10.3233/BMR-2012-0319.
PMID: 22684203BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Satit Thiengwittayaporn, M.D.
Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 10, 2016
First Posted
December 20, 2016
Study Start
December 1, 2016
Primary Completion
December 15, 2018
Study Completion
January 1, 2019
Last Updated
January 7, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share