NCT06323577

Brief Summary

The goal of this RCT is to investigate efficacy between restricted kinematic alignment and mechanical alignment TKA in simultaneous bilateral TKA patients. The main question\[s\] it aims to answer are:

  • Does rKA have better functional outcomes than MA in simultaneous bilateral TKA patients?
  • Does rKA have lower pain score than MA in simultaneous bilateral TKA patients? Participants will undergo simultaneous bilateral TKA and randomized one side will use rKA and the other side will use MA.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress97%
Mar 2024May 2026

First Submitted

Initial submission to the registry

March 14, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

March 14, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 21, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

2.2 years

First QC Date

March 14, 2024

Last Update Submit

March 14, 2024

Conditions

Osteoarthritis, KneeTKA

Keywords

restrict kinematic alignmentmechanical alignment

Outcome Measures

Primary Outcomes (1)

  • Forgotten joint score

    Point 0-100 (0 mean worst, 100 mean best)

    6 weeks, 3months, 6 months, 1 year and 2 years after surgery

Secondary Outcomes (6)

  • Modified WOMAC score

    6 weeks, 3months, 6 months, 1 year and 2 years after surgery

  • Range of motion

    6 weeks, 3months, 6 months, 1 year and 2 years after surgery

  • Pain score

    every 6 hours for 2 days after surgery then once a day for 2 weeks after surgery then once a week until 3 months after surgery

  • Hip knee ankle angle

    6 weeks, 3months, 6 months, 1 year and 2 years after surgery

  • Complications

    Until 2 years after surgery

  • +1 more secondary outcomes

Study Arms (2)

Restricted kinematic alignment

EXPERIMENTAL
Procedure: Restricted kinematic alignment

Mechanical alignment

ACTIVE COMPARATOR
Procedure: Mechanical alignment

Interventions

Restricted kinematic alignmentPROCEDURE

TKA using restricted kinematic alignment under robotic assisted surgery (MAKO).

Restricted kinematic alignment
Mechanical alignmentPROCEDURE

TKA using mechanical alignment under robotic assisted surgery (MAKO).

Mechanical alignment

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40-80 years
  • Diagnosis bilateral primary osteoarthritis of knee joint and undergo simultaneous bilateral total knee arthroplasty
  • ASA classification I-II

You may not qualify if:

  • Valgus deformity
  • BMI \> 40kg/m2
  • History of previous knee surgery
  • Active infection of the knee joint

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thammasat University

Khlong Luang, Changwat Pathum Thani, 12120, Thailand

RECRUITING

Related Publications (3)

  • Elbuluk AM, Jerabek SA, Suhardi VJ, Sculco PK, Ast MP, Vigdorchik JM. Head-to-Head Comparison of Kinematic Alignment Versus Mechanical Alignment for Total Knee Arthroplasty. J Arthroplasty. 2022 Aug;37(8S):S849-S851. doi: 10.1016/j.arth.2022.01.052. Epub 2022 Jan 31.

    PMID: 35093548BACKGROUND

  • McEwen PJ, Dlaska CE, Jovanovic IA, Doma K, Brandon BJ. Computer-Assisted Kinematic and Mechanical Axis Total Knee Arthroplasty: A Prospective Randomized Controlled Trial of Bilateral Simultaneous Surgery. J Arthroplasty. 2020 Feb;35(2):443-450. doi: 10.1016/j.arth.2019.08.064. Epub 2019 Sep 5.

    PMID: 31591010BACKGROUND

  • Van Essen J, Stevens J, Dowsey MM, Choong PF, Babazadeh S. Kinematic alignment results in clinically similar outcomes to mechanical alignment: Systematic review and meta-analysis. Knee. 2023 Jan;40:24-41. doi: 10.1016/j.knee.2022.11.001. Epub 2022 Nov 17.

    PMID: 36403396BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

March 14, 2024

First Posted

March 21, 2024

Study Start

March 14, 2024

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

March 21, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)