Psychological, Sexually and Social Consequences of Osteoarthritis Treatment With THA or TKA and Joint Preserving Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Hvidovre University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Frederiksberg University Hospital
Aarhus University Hospital
University Hospital Koge
Information provided by (Responsible Party):
Jakob Klit, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01305759
First received: February 28, 2011
Last updated: September 19, 2011
Last verified: September 2011
  Purpose

The project runs as a Ph.d. project at the Faculty of Health Sciences- University of Copenhagen.

In Denmark the investigators operate around 16.000 artificial hips and knees yearly, mainly due to osteoarthritis. The numbers has increased with 13,9% for hips and 50,7% for knees in the period 2004 to 2007. In 10% of the cases, or approximately 1.600 patients, the patient is younger than 50 years - mid-life, working, socially active and sexually active. The investigators have a tendency within in the orthopedic society to mainly focus on the technological aspects of the procedure and tend to forget that this is a key event for the patient with widespread consequences for the patient and his future life.

Hip- and knee arthroplasties is without no doubt two of the most important and successfully surgical procedures ever introduced. The economical cost for osteoarthritis treatment has exploded in the developed world over the last decade, with a yearly growth on 8%.

Because of the limited lifetime for an artificial hip or knee, this treatment can be unfortunate for the young patient. This has over the last years led to an increased interest for joint preserving surgery. Over the last twenty years it has been tried to delay the time for total hip arthroplasties for patients with hip dysplasia with the aid of Ganz osteotomy. Since this technique was introduced back in 1988, the research on the topic has had its main focus on optimizing the operation technique. So as with surgery with artificial hip or knee the investigators have a lack of knowledge regarding the social, work related, psychological and sexual aspects of this treatment.

Purpose The consequences of an artificial hip or knee joint regarding patients' social-life, work, psychological and sexual aspects gain very little attention international. The investigators apply most of our research funds exclusively to research and development of the surgical track and procedure, new prosthesis designs or coatings. The investigators find this study highly relevant because this kind of studies has been preformed for several chronic diseases but not osteoarthritis and its treatment.

With this study the investigators wish to examine the social, work related, psychological and sexual aspects of end stage osteoarthritis. This will lead the way for improved information to the patient and improve the surgeons' possibilities for chosen the correct time for surgery.


Condition
Osteoarthritis
Depression
Hip Dysplasia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Psychological, Sexually and Social Consequences of Osteoarthritis Treatment With Total Hip or Total Knee Arthroplasties and Joint Preserving Surgery

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • SF-36 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    1. What are the Health-Related-Quality-Of-Life(HRQoL) consequences of end-stage hip or knee OA? We will investigate this with SF-36, a standardized and validated questionnaire that explores HRQOL


Secondary Outcome Measures:
  • social class [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    2. What is the relation between the pre- and postoperative joint function and the patients HRQoL, and do this relation reflects the patient's social class and attachment to the workforce.


Estimated Enrollment: 250
Study Start Date: April 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
YoungTKA
Adults under 60 years who are having primary TKA
YOUNGTHA
Adults under 60 years who are having primary THA
PAOAarhus
Adults under 60 years who are having primary PAO

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Young adults undergoing TKA/THA/PAO with now other major health complications.

Criteria

Inclusion Criteria:

  • Patients born from 01.01.1950, who are submitted fore primary THA or TKA on Hvidovre University Hospital, Frederiksberg University Hospital or Køge Hospital.
  • The patient has to be capable of understanding Danish
  • The patient has to be mental well an capable of understanding the information
  • The patient must not have other major diseases

Exclusion Criteria:

  • Terminal diseases
  • Lack of ability to follow the department's standard procedures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01305759

Locations
Denmark
Hvidovre University Hospital
Hvidovre, Copenhagen, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Frederiksberg University Hospital
Aarhus University Hospital
University Hospital Koge
Investigators
Study Director: Jakob Klit, Dr Hvidovre University Hospital, Copenhagen, Denmark
  More Information

No publications provided

Responsible Party: Jakob Klit, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01305759     History of Changes
Other Study ID Numbers: PhD-JK-01
Study First Received: February 28, 2011
Last Updated: September 19, 2011
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Hvidovre University Hospital:
Total knee arthroplasty
Total hip arthroplasty
Peri acetabular osteotomy
Social class
Health related quality of life

Additional relevant MeSH terms:
Depression
Osteoarthritis
Hip Dislocation, Congenital
Behavioral Symptoms
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on October 01, 2014