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The Comparison of Anterior Knee Pain in Patella With or Without Denervation in Medial Unicompartmental Knee Arthroplasty

Primary Purpose

Osteoarthritis, Knee

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

patella denervation

patella non-denervation

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients who diagnose with medial osteoarthritis (OA) of the knee with an Alhback score of 2, 3 and 4 (Ahlback 1968) and with any Kujala score for pre-operative anterior knee pain.
Older than 40 years of age.
pain on the medial joint line.
primary medial compartment osteoarthritis with a well preserved lateral compartment with competent cruciate ligaments with correctable intraarticular varus deformity.
ROM flexion up to 110° under anesthesia.

Exclusion Criteria:

Patients with fixed varus deformity > 15°
Inflammatory arthritis
Previous high tibial osteotomy or ACL reconstruction

Sites / Locations

Pranungkraw General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

unicompartment knee arthroplasty and patella denervation

unicompartment knee arthroplasty and patella non-denervation

Arm Description

UKA and patella denervation

UKA and patella non-denervation

Outcomes

Primary Outcome Measures

Kujala score

Kujala score including 13 parameters with the score of 0-100, the higher the score the better the function.

Secondary Outcome Measures

complication

number of participant with DVT, infections, loosening of implants, fractures, lateral compartment arthritis, and dislocations of the polyethylene

Full Information

NCT ID

NCT03676179

First Posted

September 16, 2018

Last Updated

March 31, 2019

Sponsor

Ramathibodi Hospital

Collaborators

Pranungkraw General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03676179

Brief Title

The Comparison of Anterior Knee Pain in Patella With or Without Denervation in Medial Unicompartmental Knee Arthroplasty

Official Title

The Comparison of Anterior Knee Pain in Patella With or Without Denervation in Medial Unicompartmental Knee Arthroplasty

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

March 1, 2018 (Actual)

Primary Completion Date

April 1, 2019 (Actual)

Study Completion Date

April 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ramathibodi Hospital

Collaborators

Pranungkraw General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

the present study will conduct to assess anterior knee pain and complications after medial UKA with or without patella denervation in medial compartment arthritis and severe lateral facet patellofemoral arthritis patients.

Detailed Description

In this prospective cohort study, the investigators will conduct to compare the clinical result of 70 patients of unicompartment knee arthroplasty with and without patella denervation between April, 2018 and April, 2019 for the patients with osteoarthritis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

unicompartment knee arthroplasty with patella denervation

Masking

InvestigatorOutcomes Assessor

Masking Description

unicompartment knee arthroplasty without patella denervation

Allocation

Non-Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

unicompartment knee arthroplasty and patella denervation

Arm Type

Active Comparator

Arm Description

UKA and patella denervation

Arm Title

unicompartment knee arthroplasty and patella non-denervation

Arm Type

Experimental

Arm Description

UKA and patella non-denervation

Intervention Type

Procedure

Intervention Name(s)

patella denervation

Intervention Description

patella denervation

Intervention Type

Procedure

Intervention Name(s)

patella non-denervation

Intervention Description

patella non-denervation

Primary Outcome Measure Information:

Title

Kujala score

Description

Kujala score including 13 parameters with the score of 0-100, the higher the score the better the function.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

complication

Description

number of participant with DVT, infections, loosening of implants, fractures, lateral compartment arthritis, and dislocations of the polyethylene

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients who diagnose with medial osteoarthritis (OA) of the knee with an Alhback score of 2, 3 and 4 (Ahlback 1968) and with any Kujala score for pre-operative anterior knee pain. Older than 40 years of age. pain on the medial joint line. primary medial compartment osteoarthritis with a well preserved lateral compartment with competent cruciate ligaments with correctable intraarticular varus deformity. ROM flexion up to 110° under anesthesia. Exclusion Criteria: Patients with fixed varus deformity > 15° Inflammatory arthritis Previous high tibial osteotomy or ACL reconstruction

Facility Information:

Facility Name

Pranungkraw General Hospital

City

Bangkok

Country

Thailand

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32743756

Citation

Suwankomonkul P, Arirachakaran A, Kongtharvonskul J. Short-term improvement of patellofemoral pain in medial unicompartmental knee arthroplasty with patellar denervation: a prospective comparative study. Musculoskelet Surg. 2022 Mar;106(1):75-82. doi: 10.1007/s12306-020-00675-7. Epub 2020 Aug 2.

Results Reference

derived

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The Comparison of Anterior Knee Pain in Patella With or Without Denervation in Medial Unicompartmental Knee Arthroplasty

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