NCT03389880

Brief Summary

The purpose of this study is to compare the post-operative anterior knee pain (AKP) between patellar denervation and non-patellar denervation in total knee arthroplasty with patellar resurfacing

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

December 21, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 4, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2020

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2020

Completed
Last Updated

November 23, 2020

Status Verified

November 1, 2020

Enrollment Period

2.7 years

First QC Date

December 20, 2017

Last Update Submit

November 20, 2020

Conditions

Patellar DenervationNon-patellar DenervationPatellar Resurfacing

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (8)

  • range of motion of knee

    Change from baseline range of motion of knee at 3 months, 6 months, and 12 months after surgery

  • 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

  • New patellar score (Bartlett score)

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

  • Oxford knee score

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

  • patellar shift index

    Change from baseline 3 months, 6 months, and 12 months after surgery

  • +3 more secondary outcomes

Study Arms (2)

Patellar denervation

ACTIVE COMPARATOR
Procedure: Total knee arthroplastyProcedure: Patellar denervation

Non-patellar denervation

EXPERIMENTAL
Procedure: Total knee arthroplasty

Interventions

Total knee arthroplastyPROCEDURE

A surgical procedure in which parts of the knee joint are replaced with artificial parts (prostheses)

Non-patellar denervationPatellar denervation
Patellar denervationPROCEDURE

circumpatellar electrocautery with monopolar coagulation diathermy

Patellar denervation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Navamindradhiraj University

Dusit, Bangkok, 10300, Thailand

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

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

December 20, 2017

First Posted

January 4, 2018

Study Start

December 21, 2017

Primary Completion

August 15, 2020

Study Completion

August 20, 2020

Last Updated

November 23, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)