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

NCT03650426 | Completed

• 1 other identifier: COA 017/2561
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 1

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

Conditions

Onlay Patellar Resurfacing Technique; Inlay Patellar Resurfacing Technique; Patellar Resurfacing

Outcome Measures

Primary Outcomes (7)

• Change of post-operative anterior knee pain

  Visual Analog Scale for anterior knee pain (minimum 0, maximum 10) Do higher values represent a worse outcome

  Change from baseline Visual Analog Scale for anterior knee pain at 3 months, 6 months, and 12 months after surgery

• range of motion of knee

  Knee Society and Knee Society function score (minimum 0, maximum 200)

  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

  Knee Society and Knee Society function score (minimum 0, maximum 200)

  Change from baseline Knee Society and Knee Society function score at 3 months, 6 months, and 12 months after surgery

• New patellar score

  New patellar score (minimum 0, maximum 30)

  Change from baseline new patellar score at 3 months, 6 months, and 12 months after surgery

• Oxford knee score

  Oxford knee score (minimum 0, maximum 48)

  Change from baseline Oxford knee score 3 months, 6 months, and 12 months after surgery

• Prevalence of anterior knee pain ,AKP

  Prevalence of anterior knee pain ,AKP (minimum 0, maximum 10)

  Change from baseline Prevalence of anterior knee pain ,AKP 3 months, 6 months, and 12 months after surgery

• Prevalence of patellar crepitus complication

  Prevalence of patellar crepitus complication (present, absent)

  Change from baseline patellar crepitus complication 3 months, 6 months, and 12 months after surgery

Study Arms (2)

Onlay patellar resurfacing technique

ACTIVE COMPARATOR

Procedure: Total knee with onlay patellar resurfacing technique

Inlay patellar resurfacing technique

EXPERIMENTAL

Procedure: Total knee with inlay patellar resurfacing technique

Interventions

Total knee with onlay patellar resurfacing technique PROCEDURE

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

Onlay patellar resurfacing technique

Total knee with inlay patellar resurfacing technique PROCEDURE

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

Inlay patellar resurfacing technique

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Navamindradhiraj University: lead

Study Sites (1)

Navamindradhiraj University

Dusit, Bangkok, 10300, Thailand

Location

Study Officials

• Satit Thiengwittayaporn, M.D.

  Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: August 28, 2018
• Study Start: February 20, 2018
• Primary Completion: February 20, 2020
• Study Completion: February 20, 2020
• Last Updated: April 20, 2021

Record last verified: 2018-07

Locations

TH (1)