NCT05936814

Brief Summary

The restoration of the joint line (JL) is essential for the proper functioning of Total Knee Arthroplasty (TKA). The exact position of JL can be determined using anatomical landmarks such as femoral condylar width (TEW), tibial tubercle, fibular head, and adductor tubercle during preoperative planning or intraoperatively. However, in cases of severe varus deformity in Type M gonarthrosis, it is unknown which method is most suitable for accurately determining the precise JL position. The aim of this study is to identify the most appropriate method for determining the JL position in Type M gonarthrosis. To achieve this goal, two groups of patients with Type 1A and Type M gonarthrosis will be compared by measuring preoperative values and comparing them with intraoperative reference values.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
9mo left

Started Dec 2021

Longer than P75 for all trials

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 Progress86%
Dec 2021Jan 2027

Study Start

First participant enrolled

December 1, 2021

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2023

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Expected
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

1.6 years

First QC Date

June 20, 2023

Last Update Submit

July 8, 2023

Conditions

Osteoarthritis, KneeGenu VarumJoint Prosthesis; Complications

Keywords

Varus deformityAdductor tubercleJoint line restorationTotal knee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Determination of joint Line according to adductor ratio

    Comparison of preoperative and intraoperative measurement of Adductor ratio (adductor tubercle to joint line/transepicondylar width; mm/mm)

    comparison between baseline (preoperative and intraoperative) measurements

Secondary Outcomes (2)

  • Determination of joint Line according to distance from medial and lateral epicondyles to joint line

    comparison between baseline (preoperative and intraoperative) measurements

  • HSS (Hospital for Special Surgery) knee score

    comparison between preoperative and postoperative 12th month control

Study Arms (2)

Intraarticular

The control group with intraarticular varus deformity and Kellgren and Lawrence grade 4 gonarthrosis.

Procedure: total knee arthroplasty

Metaphyseal

The case group with Metaphyseal varus deformity and Kellgren and Lawrence grade 4 gonarthrosis.

Procedure: total knee arthroplasty

Interventions

total knee arthroplastyPROCEDURE

cemented bicondylar PCL substituting total knee replacement

IntraarticularMetaphyseal

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with KL Grade 4 severe OA with type M severe varus malalignment or just KL4 OA with intraarticular type 3 and 4 deformity according to Parvizi classification of varus gonarthrosis

You may qualify if:

  • Patients over 65 years of age
  • Candidates with varus alignment osteoarthritis of the knee
  • Patients with complete data set
  • Patients who have agreed to participate in the study

You may not qualify if:

  • Patients who did not provide consent to participate in the study
  • Patients with post-traumatic osteoarthritis
  • Patients with inflammatory type of osteoarthritis
  • Patients with incomplete data set

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Keçiören SUAM

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, KneeGenu Varum

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBone Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • murat altay

    Saglik Bilimleri Universitesi

    STUDY CHAIR

Central Study Contacts

süheyla atay

CONTACT

00902167778777suheylaatay81@gmail.com

bülent karslıoğlu

CONTACT

00905058106373

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

June 20, 2023

First Posted

July 10, 2023

Study Start

December 1, 2021

Primary Completion

June 30, 2023

Study Completion (Estimated)

January 31, 2027

Last Updated

July 11, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP

Locations

TU(1)