NCT03358381

Brief Summary

Gap balance type and measured resection type total knee arthroplasty (TKA) have different influence on the rotation of femoral component.In this study, the rotation of patients received different type of TKA will be estimated and analysed through preoperation and postoperation knee joint CT scan.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Status
unknown

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

November 25, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 30, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

November 30, 2017

Status Verified

November 1, 2017

Enrollment Period

12 months

First QC Date

November 25, 2017

Last Update Submit

November 26, 2017

Conditions

Osteoarthritis, Knee

Keywords

total knee arthroplastyCT scan

Outcome Measures

Primary Outcomes (1)

  • femoral component rotation

    The change of femoral component will be assessed through preoperation as well as postoperation CT scan for knee joint.

    6 weeks after the surgery

Study Arms (2)

gap balance group

EXPERIMENTAL

The type of total knee arthroplasty will be the balance gap.The gap balance type of total knee arthroplasty will be performed.

Procedure: the gap balance type of total knee arthroplasty

measured resection group

ACTIVE COMPARATOR

The type of total knee arthroplasty will be the measured resection.The measured resection type of total knee arthroplasty will be performed.

Procedure: the measured resection type of total knee arthroplasty

Interventions

the gap balance type of total knee arthroplastyPROCEDURE

A gap balance type of total knee arthroplasty surgery will be performed.The gap balance group will receive this kind of intervention.

gap balance group
the measured resection type of total knee arthroplastyPROCEDURE

A measured resection type of total knee arthroplasty surgery will be performed.The measured resection group will receive this kind of intervention.

measured resection group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Severe primary osteoarthritis patients over 65 years old No obvious surgical contraindications

You may not qualify if:

  • There are surgical contraindications Varus or valgus alignment exceeds 20 degrees

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Jianhao Lin, MD

    arthritis clinic and research center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leyuan Chen

CONTACT

18600116051chenleyuanqia@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
arthritis clinic and research center

Study Record Dates

First Submitted

November 25, 2017

First Posted

November 30, 2017

Study Start

January 1, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

November 30, 2017

Record last verified: 2017-11