NCT00175201

Brief Summary

In this randomised study a proactive care and rehabilitation intervention is compared to the current care and rehabilitation in patients undergoing primary hip and knee replacement surgery. A cost efficacy analysis in a societal perspective is made from effect data in the randomised controlled study together with cost data gathered during the perioperative and postoperative period. If the proactive care and rehabilitation intervention is cost effective the intervention is going to be implemented in Ringkøbing County. This implementation proces is measured within a monitoring project of all patients receiving hip or knee replacement surgery in Ringkøbing County in the period 2003 to 2007.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
247

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2006

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2008

Completed
Last Updated

December 23, 2022

Status Verified

December 1, 2022

Enrollment Period

1.7 years

First QC Date

September 10, 2005

Last Update Submit

December 21, 2022

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (4)

  • Health relatede quality of life

  • Pain

  • Disabillity

  • Costs

Interventions

Proactive care and rehabilitationPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Primary osteoarthritis of the hip and knee -

You may not qualify if:

  • Non-cooperative Replacement secondary to fracture Revision surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kristian Larsen

Holstebro, Jutland, 7500, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Kjeld Søballe, DMSC

    Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 15, 2005

Study Start

May 1, 2005

Primary Completion

December 31, 2006

Study Completion

December 31, 2008

Last Updated

December 23, 2022

Record last verified: 2022-12

Locations

DK(1)