Primary Constrained Condylar Knee Arthroplasty Without Stem Extensions: Prevalence and Risk Factors

Constrained Insert in Knee Arthroplasty Clinical Trial

Official title:

Primary Constrained Condylar Knee Arthroplasty Without Stem Extensions: Prevalence and Risk Factors

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03202225
• Other study ID #: COA 61/2560
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 25, 2017
• Last updated: December 20, 2017
• Start date: May 17, 2017
• Est. completion date: April 2018

Study information

• Verified date: November 2017
• Source: Navamindradhiraj University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 246
• Est. completion date: April 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• primary knee osteoarthritis

• primary total knee replacement

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Constrained Insert in Knee Arthroplasty

Intervention

Device:
• constrained polyethylene
constrained polyethylene insert

Locations

Country	Name	City	State
Thailand	Navamindradhiraj University	Dusit	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Navamindradhiraj University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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