Psychological, Sexually and Social Consequences of Osteoarthritis Treatment With THA or TKA and Joint Preserving Surgery
|ClinicalTrials.gov Identifier: NCT01305759|
Recruitment Status : Completed
First Posted : March 1, 2011
Last Update Posted : April 18, 2017
|First Submitted Date||February 28, 2011|
|First Posted Date||March 1, 2011|
|Last Update Posted Date||April 18, 2017|
|Study Start Date||April 2010|
|Actual Primary Completion Date||April 2012 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures
||SF-36 [ Time Frame: 3 years ]
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
|Original Primary Outcome Measures||Same as current|
|Change History||Complete list of historical versions of study NCT01305759 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures
||social class [ Time Frame: 3 years ]
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.
|Original Secondary Outcome Measures||Same as current|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Psychological, Sexually and Social Consequences of Osteoarthritis Treatment With THA or TKA and Joint Preserving Surgery|
|Official Title||Psychological, Sexually and Social Consequences of Osteoarthritis Treatment With Total Hip or Total Knee Arthroplasties and Joint Preserving Surgery|
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.
In Denmark approximately 16.000 artificial hips or knees are inserted yearly. A increasing number that probably will continue to increase due to demographic factors and the populations rising demands on a active life in the old age. However of the 16.000 artificial joints approximately 10% are inserted in patients under fifty years(1;2). This group of patients is mid-life and thereby for most parts working and socially- and sexually active.
Total hip arthroplasty(THA) or total knee arthroplasty(TKA) is unquestionably one of the most successfully operations there has been introduced, and is capable of relieving pain, optimizing the function of the joint and optimizing the quality of life(3;4). In the resent years the main focus has been on optimizing the surgical track, whereby most of the patient today are only admitted to the hospital in 1-2 days. This progress has had a tremendous impact on patients, the departments and the health care system. Joint replacement surgery with THA or TKA is a key event for the patient and can recreate the patient's mobility but as well has widespread (but still undocumented) consequences for the patient and his future life.
In the preoperative treatment and planning of the correct time of surgery, it is imported to know, how the patient is affected of a disabling joint disease like end-stage osteoarthritis(OA) and which consequences it has to the patient to have an artificial joint. It is known, that patients with OA has a two-fold increased risk of depression(8-13).
These aspects of the treatment has so far not had the desirable attention, neither national or international At Hvidovre Hospital, Frederiksberg Hospital and Køge Hospital the Orthopaedic departments has many years of experience with joint replacement surgery at specialist level. The structures of the departments are based on modern fast-track principals, with clearly defined goals for preoperative information, pre- and postoperative regimes and discharged criteria. Thereby insuring a smooth course, short rekonvalens and a minimizing of complications.
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 Peri Acetabular Osteotomy(PAO). Hip dysplasia is seen equally in both sexes. However it is more often symptomatic in females(14). In Denmark PAO is performed at Copenhagen University Hospital, Odense University Hospital and Aarhus University Hospital. The procedure is preformed on symptomatic (mainly sharp groin pain) patients in hope of delaying the development of OA. Femoroacetabular impingement (FAI) is believed to be the pathology, where repeated trauma to the acetabular labrum and adjacent chondral structures can result in labral tears and chondral delamination, leading to groin pain and over time OA. However there are only a few minor studies concerning which impact this procedure has on the young patients life in term of psychological, sexually and social wellbeing.
Patients included are both men and women from twenty to sixty years old who are admitted to undergo primary uni- or bilateral THA or TKA at Hvidovre Hospital, Frederiksberg Hospital or Køge Hospital as a result of end-stage OA, rheumatoid arthritis or another joint disease diagnosed by one of the departments doctors with specialty in joint replacement surgery. The included patients in the PAO study has all had PAO at Aarhus University Hospital between 1999-2002 and were at the age of fifteen or more at the time of surgery. To avoid co-morbidity confounders the joint disease has to be the only main disease.
The goal of the study is to investigate:
The main part of this study runs as a prospective questionnaire based study of the patients, which are having a THA or TKA at Hvidovre University Hospital, Frederiksberg University Hospital and Køge Hospital. A smaller part of the study is a retrospective questionnaire based study of the patients, which in the period 1999-2002 underwent PAO at Aarhus University Prior to planned surgery with THA or TKA the patient receive a questionnaire. This will be followed by a questionnaire 3, 6 and 12 months postoperative. Twelve months postoperative the patient will have and ambulatory control.
The patients who underwent PAO at Aarhus University Hospital in the period 1999-2002 are posted a questionnaire.
The inclusions of patients started April 2010 and runs at least to the summer of 2011 or when at least 250 patients are included.
The results are expected to be published in international English language journals and the research and findings will be defended as a PhD ad the Faculty of Health Sciences- University of Copenhagen.
Purposes of the study:
To investigate how end-stage OA and joint replacement surgery affects the patients HRQoL and herby which impact this procedure has on the young patients life in term of psychological, sexually and social wellbeing. Next the investigators wish to investigate how the patients' attachment to the workforce is affected bye end-stage OA and joint replacement surgery
To investigate how patients with other disabling joint diseases with need for joint replacement surgery is affected as described above.
Edification of a database to reveal complications over years for this well-defined young patient population, who has a higher demand to there prosthesis and as a consequence put them to a higher stress.
To investigate which impact PAO has on the young patients life in term of HRQoL, psychological, sexually and social wellbeing.
|Study Design||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
|Study Population||Young adults undergoing TKA/THA/PAO with now other major health complications.|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Original Estimated Enrollment||Same as current|
|Actual Study Completion Date||April 2013|
|Actual Primary Completion Date||April 2012 (Final data collection date for primary outcome measure)|
|Ages||16 Years to 60 Years (Child, Adult)|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||Denmark|
|Removed Location Countries|
|Other Study ID Numbers||PhD-JK-01|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Jakob Klit, Hvidovre University Hospital|
|Study Sponsor||Hvidovre University Hospital|
|PRS Account||Hvidovre University Hospital|
|Verification Date||April 2017|