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Clinical Outcomes Between Tibial Preservation Bone Cut and Conventional Tibial Bone Cut Following Medial UKA

Primary Purpose

Knee Osteoarthritis, Knee Arthropathy

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
tibial preservation bone cut
Sponsored by
Thammasat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring mobile bearing UKA, Oxford UKA, medial knee pain

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • medial osteoarthritis of knee

Exclusion Criteria:

  • posttraumatic arthritis
  • gout
  • Rheumatoid arthritis
  • anterior cruciate ligament insufficiency
  • osteonecrosis of knee

Sites / Locations

  • Boonchana Pongcharoen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

tibial preservation bone cut

tibial conventional bone cut

Arm Description

tibial preservation bone cut following mobile bearing UKA

tibial conventional bone cut following mobilebearing UKA

Outcomes

Primary Outcome Measures

visual analog scale (VAS) for pain
pain at medial tibial plateau

Secondary Outcome Measures

knee society score
The standard knee score for determining function after knee arthroplasty
Oxford knee score
The standard knee score for determining function after knee arthroplasty
joint forgotten score
The standard knee score for determining function after knee arthroplasty
knee injury osteoarthritis outcome score
The standard knee score for determining function after knee arthroplasty
Kujala score
The standard knee score for determining function after knee arthroplasty

Full Information

First Posted
June 1, 2020
Last Updated
August 29, 2021
Sponsor
Thammasat University
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1. Study Identification

Unique Protocol Identification Number
NCT04419116
Brief Title
Clinical Outcomes Between Tibial Preservation Bone Cut and Conventional Tibial Bone Cut Following Medial UKA
Official Title
Faculty of Medicine, Thammasat University
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
November 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thammasat University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The mobile bearing unicompartmental knee arthroplasty has shown excellent clinical outcome and survivorship. However, some studies have shown that the patients still had medial knee pain and shown worst the clinical outcome, even though the survivorship was excellent. The medial knee pain after operation was the one cause of revision. The incidence of medial knee pain was 0%-9%. The cause of medial knee pain was overloading on the medial plateau, local inflammation, over hanging of the tibial component and overstretching of the MCL due to the application of excessive polyethylene. Therefore, the tibia in this study was cut with under resection technique for reducing the overloading on the medial tibial plateau. The purpose of this study is to compare medial knee pain between tibial bone cut preservation technique and conventional tibial bone cut technique following mobile bearing UKA.
Detailed Description
A randomized control trial study was conducted at Thammasat University hospital, Thailand. The inclusion criteria were patients with medial osteoarthritis (OA) of the knee with an Alhback score of 2, 3 and 4, who were older than 50 years of age, with a range of movement (ROM) > 90°, a varus deformity < 25°, and flexion contracture < 20° who underwent a medial mobile bearing UKA (Oxford UKA; Zimmer Biomet, Inc, Warsaw, IN, USA), performed by a single surgeon. The exclusion criteria were patients with a diagnosis of spontaneous osteonecrosis of the knee (SPONK), intraoperative anterior cruciate ligament (ACL) insufficiency, inflammatory joint disease, gout, post-traumatic arthritis, and primary PF arthritis. The patients were randomized with computer technique into 2 groups, group (gp) I, conventional tibial bone cut technique and gp II, tibial bone cut preservation technique. The baseline patient characteristics included age, sex, site, the Knee Society Score© (KSS) (knee score, pain score, and functional score), Oxford knee score (OKS), KOOS, Kujara score, body mass index (BMI), degree of varus deformity, flexion contracture, genu recurvatum, and range of motion (ROM) were recorded. The patients were followed up at 2 weeks, 6 weeks, 3months, 6months, 1 years, and annually. The VAS ofr medial knee and incidence of medial knee pain were assessed in a blinded fashion by a research assistant at each visit using VAS scale (0-10). The KSS, OKS, KOOS, and Kujara score also were recorded. At each follow-up, the patients underwent AP standing, lateral standing, skyline view, and long-leg radiographs and the component alignment, tibiofemoral angle and joint line of femur and tibia recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Knee Arthropathy
Keywords
mobile bearing UKA, Oxford UKA, medial knee pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tibial preservation bone cut
Arm Type
Experimental
Arm Description
tibial preservation bone cut following mobile bearing UKA
Arm Title
tibial conventional bone cut
Arm Type
Experimental
Arm Description
tibial conventional bone cut following mobilebearing UKA
Intervention Type
Procedure
Intervention Name(s)
tibial preservation bone cut
Intervention Description
tibial preservation bone cut: removing of proximal tibial less than conventional tibial bone cut with 2mm.
Primary Outcome Measure Information:
Title
visual analog scale (VAS) for pain
Description
pain at medial tibial plateau
Time Frame
2 years
Secondary Outcome Measure Information:
Title
knee society score
Description
The standard knee score for determining function after knee arthroplasty
Time Frame
2 years
Title
Oxford knee score
Description
The standard knee score for determining function after knee arthroplasty
Time Frame
2 years
Title
joint forgotten score
Description
The standard knee score for determining function after knee arthroplasty
Time Frame
2 years
Title
knee injury osteoarthritis outcome score
Description
The standard knee score for determining function after knee arthroplasty
Time Frame
2 years
Title
Kujala score
Description
The standard knee score for determining function after knee arthroplasty
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: medial osteoarthritis of knee Exclusion Criteria: posttraumatic arthritis gout Rheumatoid arthritis anterior cruciate ligament insufficiency osteonecrosis of knee
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boonchana Pongcharoen
Organizational Affiliation
faculty of medicine, Thammasat university
Official's Role
Study Director
Facility Information:
Facility Name
Boonchana Pongcharoen
City
Pathum Thani
ZIP/Postal Code
12120
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Outcomes Between Tibial Preservation Bone Cut and Conventional Tibial Bone Cut Following Medial UKA

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