Effects of Total Knee Replacement on Early Postoperative... | NCT02387541

Studies
Effects of Total Knee Replacement on Early Postoperative Cognitive Function in Elderly Patients

NCT02387541

Sponsor

General Hospital of Ningxia Medical University

Status

Completed

Last Update Posted

May 3, 2016Estimated

Enrollment

100Actual

Phase

Not provided

Conditions

Perioperative Complications

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Dec 2013Actual

Completion Date

Jan 2014Actual

First Submitted Date

Mar 6, 2015

First Submission Date that Met QC Criteria

Mar 12, 2015

First Posted Date

Mar 13, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 1, 2016

Last Update Posted Date

May 3, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To investigate the effects of total knee replacement is harmful to Postoperative cognitive dysfunction

Detailed Description

Postoperative cognitive dysfunction (POCD) is reported to occur after major surgery in elderly patients. They may especially experience problems in the weeks and months after surgery. Recent studies vary greatly in methods of evaluation and diagnosis of POCD, and the pathogenic mechanisms are still unclear. The investigators evaluated a large uniform cohort of elderly patients in a standardized approach after total knee replacement.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Week

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effects of operation on early postoperative cognitive function in elderly patients		up to 7days postoperatively

Secondary Outcomes

Measure	Description	Time Frame
Postoperative cognitive dysfunction (POCD) was defined by Mini-Mental State Examination (MMSE) score		up to 7days postoperatively

Other Outcomes

Measure	Description	Time Frame
serum concentration of inflammatory cytokine	The blood samples were reserved before anesthesia induction and 24h after surgery for detecting the concentrations of IL-1, IL-6, and IL-10 by enzyme-linked immunosorbent assay (ELISA).	The blood samples were reserved before anesthesia induction and 24h after surgery

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

aged ≥65 years;
ASA I or Ⅱ;
total knee replacement

Exclusion Criteria:

Mini Mental State Examination [MMSE] score too low.
Parkinson or other neurological disease causing functional impairment.
Patients with a history of alcohol abuse (≥35 U per week) or daily use of anxiolytics were also excluded, as well as those with severe hearing or visual impairment.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

We included 96 ASA I or Ⅱ patients aged ≥65 years performed total knee replacement under general anesthesia.

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D000079690	Postoperative Cognitive Complications

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D060825	Cognitive Dysfunction

Browse Leaves

Not provided

Browse Branches

Not provided