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

• Sponsor: Navamindradhiraj University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03650426
• Collaborator: (none)
• Enrollment: 235
• Location: 1
• Arms: 2
• Actual Duration (Months): 24
• Patients Per Site Per Month: 9.8

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Feb 20, 2018
• Actual Primary Completion Date: Feb 20, 2020
• Actual Study Completion Date: Feb 20, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change of post-operative anterior knee pain [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 [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 [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 [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 [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 [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 [Change from baseline patellar crepitus complication 3 months, 6 months, and 12 months after surgery]

   Prevalence of patellar crepitus complication (present, absent)

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Navamindradhiraj University	Dusit	Bangkok,	Thailand	10300

Sponsors and Collaborators

• Navamindradhiraj University

Investigators

• Principal Investigator: Satit Thiengwittayaporn, M.D., Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Satit Thiengwittayaporn, Associate Professor, Navamindradhiraj University
• ClinicalTrials.gov Identifier: NCT03650426
• Other Study ID Numbers: COA 017/2561
• First Posted: Aug 28, 2018
• Last Update Posted: Apr 20, 2021
• Last Verified: Jul 1, 2018

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

Study Results

No Results Posted as of Apr 20, 2021