NCT02845960

Brief Summary

The purpose of this study is to evaluate the influence of rapid recovery on sleep quality following total knee replacement surgery.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
170

participants targeted

Target at P50-P75 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

February 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Last Updated

July 27, 2016

Status Verified

July 1, 2016

Enrollment Period

1.5 years

First QC Date

July 23, 2016

Last Update Submit

July 26, 2016

Conditions

Arthroplasty, Replacement, KneeRecovery of FunctionArthritis, Rheumatoid

Outcome Measures

Primary Outcomes (7)

  • WOMAC score

    1 mounth

  • GAD-7

    1 mounth

  • PSQI index

    1 mounth

  • Insomnia severity index

    1 mounth

  • polysomnographic measurement

    1 mounth

  • VAS

    1 mounth

  • Range of motion

    1 mounth

Study Arms (2)

Experimental group

rapid recovery

Behavioral: rapid recovery

Controlled group

no rapid recovery

Interventions

rapid recoveryBEHAVIORAL

rapid recovery

Experimental group

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Chinese

You may qualify if:

  • Primary unilateral total knee artropasty;
  • Patients with Knee osteoartritis or Rheumatoid arthritis;
  • Able and willing to provide signed informed consent.

You may not qualify if:

  • Simultaneously bilateral total knee artropasty or revision case;
  • Surgical History of the knee joint;
  • Knee joint cavity paracentesis in recent 3 months;
  • Stiffness with knee;
  • Blood coagulation disorders;
  • History of deep venous thrombosis;
  • Concomitant medical problems such as uncontrolled hypertention, severe cardiovascular disorder, chronic obstructive pulmonary disease, liver or renal failure
  • allergic to NSAIDs, opioid analgesics, zolpidem
  • sleep apnea, Parkinson disease, dementia, depression
  • use of sedatives or hypnotics
  • inability to comply with polysomnographic measurement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

WEINAN ZENG, Doctor

CONTACT

+8615023100103weinanzeng@163.com

JUNLI LIU, Doctor

CONTACT

8613452067520tmmuljl@163.com

Study Design

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

Study Record Dates

First Submitted

July 23, 2016

First Posted

July 27, 2016

Study Start

February 1, 2016

Primary Completion

August 1, 2017

Last Updated

July 27, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)