NCT02137655

Brief Summary

The development and implementation of "fast-track" principles in total knee and hip arthroplasty have resulted in early recovery and rehabilitation alongside a reduced length of hospital stay. This without a concomitant increase in morbidity or readmissions for medical or surgical complications and with reduced mortality. However, only little is known about function in the subacute period after arthroplasty, and there is a need for further data on physical and psychological functioning following discharge from hospital.This to ensure, that the positive results from the perioperative setting are carried forward in the subacute phase.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2014

Geographic Reach
1 country

2 active sites

Status
completed

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 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

March 9, 2016

Status Verified

March 1, 2016

Enrollment Period

1.8 years

First QC Date

May 12, 2014

Last Update Submit

March 8, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain

    VAS when walking

    48 hours postoperatively

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with hip or knee osteoarthritis referred for total joint arthroplasty.

You may qualify if:

  • Primary total hip or knee arthroplasty
  • Age 55 to 80 years

You may not qualify if:

  • Deficient written or spoken danish
  • Alcohol abuse (\>21 U per week)
  • Immunocompromised
  • Anticoagulant therapy
  • ASA class 4-5
  • Functional impairment from psychological or neurological disease
  • Sleepapnea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gentofte hospital

Gentofte Municipality, Capital Region, 2820, Denmark

Location

Vejle Sygehus

Vejle, Region Syd, 7100, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

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

Study Record Dates

First Submitted

May 12, 2014

First Posted

May 14, 2014

Study Start

May 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

March 9, 2016

Record last verified: 2016-03

Locations