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Comparison Between the Onlay and Inlay Techniques for Patellar Resurfacing in Posterior Cruciate Ligament-Substituting Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03650426
Recruitment Status : Completed
First Posted : August 28, 2018
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Satit Thiengwittayaporn, Navamindradhiraj University

Brief Summary:
The purpose of this study is to compare clinical outcome in posterior cruciate ligament-substituting total knee arthroplasty with onlay patellar resurfacing technique and inlay patellar resurfacing technique

Condition or disease Intervention/treatment Phase
Onlay Patellar Resurfacing Technique Inlay Patellar Resurfacing Technique Patellar Resurfacing Procedure: Total knee with onlay patellar resurfacing technique Procedure: Total knee with inlay patellar resurfacing technique Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 235 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Between the Onlay and Inlay Techniques for Patellar Resurfacing in Posterior Cruciate Ligament-Substituting Total Knee Arthroplasty: A Prospective, Randomized Controlled Trial
Actual Study Start Date : September 30, 2018
Actual Primary Completion Date : February 15, 2020
Actual Study Completion Date : February 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Active Comparator: Onlay patellar resurfacing technique Procedure: Total knee with onlay patellar resurfacing technique
The patellar resurfacing technique that the patellar implant is embedded on the patellar bone.The patellar implant is placed on top of a flat tibial osteotomy or cut-surfaced bone

Experimental: Inlay patellar resurfacing technique Procedure: Total knee with inlay patellar resurfacing technique
The patellar resurfacing technique that the patellar implant is embedded in the patellar bone.The patellar implant is surrounded by a rim of cortical bone and supported by hardened, sclerotic bone




Primary Outcome Measures :
  1. Change of post-operative anterior knee pain [ Time Frame: Change from baseline Visual Analog Scale for anterior knee pain at 3 months, 6 months, and 12 months after surgery ]
    Visual Analog Scale for anterior knee pain (minimum 0, maximum 10) Do higher values represent a worse outcome

  2. range of motion of knee [ Time Frame: Change from baseline Knee Society and Knee Society function score at 3 months, 6 months, and 12 months after surgery ]
    Knee Society and Knee Society function score (minimum 0, maximum 200)

  3. Knee Society and Knee Society function score [ Time Frame: Change from baseline Knee Society and Knee Society function score at 3 months, 6 months, and 12 months after surgery ]
    Knee Society and Knee Society function score (minimum 0, maximum 200)

  4. New patellar score [ Time Frame: Change from baseline new patellar score at 3 months, 6 months, and 12 months after surgery ]
    New patellar score (minimum 0, maximum 30)

  5. Oxford knee score [ Time Frame: Change from baseline Oxford knee score 3 months, 6 months, and 12 months after surgery ]
    Oxford knee score (minimum 0, maximum 48)

  6. Prevalence of anterior knee pain ,AKP [ Time Frame: Change from baseline Prevalence of anterior knee pain ,AKP 3 months, 6 months, and 12 months after surgery ]
    Prevalence of anterior knee pain ,AKP (minimum 0, maximum 10)

  7. Prevalence of patellar crepitus complication [ Time Frame: Change from baseline patellar crepitus complication 3 months, 6 months, and 12 months after surgery ]
    Prevalence of patellar crepitus complication (present, absent)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary osteoarthritis of knee who were scheduled for a primary total knee arthroplasty

Exclusion Criteria:

  • Valgus deformity
  • History of inflammatory arthroplathy
  • Previous fracture or open surgery on the same knee
  • History of patellar instability

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03650426


Locations
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Thailand
Navamindradhiraj University
Dusit, Bangkok,, Thailand, 10300
Sponsors and Collaborators
Navamindradhiraj University
Investigators
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Principal Investigator: Satit Thiengwittayaporn, M.D. Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University
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Responsible Party: Satit Thiengwittayaporn, Associate Professor, Navamindradhiraj University
ClinicalTrials.gov Identifier: NCT03650426    
Other Study ID Numbers: COA 017/2561
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No