NCT03202225

Brief Summary

While performing a primary TKA in consecutive patients, a constrained insert may be necessary when adequate stability and soft tissue balance are not obtained. In this retrospective study, The investigators aim to identify the prevalence and risk factors that associate with the use of a constrained insert in primary TKA.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
246

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

May 17, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 25, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 28, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

December 21, 2017

Status Verified

November 1, 2017

Enrollment Period

7 months

First QC Date

June 25, 2017

Last Update Submit

December 20, 2017

Conditions

Constrained Insert in Knee Arthroplasty

Outcome Measures

Primary Outcomes (2)

  • prevalence to use constrained insert in primary total knee arthroplasty

    to identify the prevalence that associate with the use of a constrained insert in primary total knee arthroplasty

    intraoperative

  • risk factors to use constrained insert in primary total knee arthroplasty

    to identify the risk factors that associate with the use of a constrained insert in primary total knee arthroplasty such as degree of preoperative deformity, degree of preoperative instability

    intraoperative

Interventions

constrained polyethyleneDEVICE

constrained polyethylene insert

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

consecutive patients underwent primary total knee arthroplasty at our institution

You may qualify if:

  • primary knee osteoarthritis
  • primary total knee replacement

You may not qualify if:

  • secondary knee osteoarthritis
  • revision total knee replacement
  • previous knee surgery
  • post-traumatic knee
  • history of previously infection
  • comorbidity;rheumatoid arthritis, connective tissue disease, neuromuscular disease, lumbar spinal stenosis, neuropathy
  • severe osteoporosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Navamindradhiraj University

Dusit, Bangkok, 10300, Thailand

Location

Study Officials

  • Satit Thiengwittayaporn, M.D.

    Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 25, 2017

First Posted

June 28, 2017

Study Start

May 17, 2017

Primary Completion

December 1, 2017

Study Completion

April 1, 2018

Last Updated

December 21, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)