Trial document





This trial has been registered retrospectively.
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  DRKS00011345

Trial Description

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Title

The effectiveness of rehabilitation after a Total Hip Arthroplasty (THA): A comparison of Usual Care in the Netherlands versus Germany

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Osteoarthritis (OA) is the most common joint disorder in the world. In end stage hip OA, surgical implantation of a Total Hip Arthroplasty (THA) is considered one of the most (cost) effective treatments. Due to projected growth of the older population and obesity epidemic, the number of THAs is expected to increase dramatically in the coming decades. Usual postoperative rehabilitation after primary THA differs between the German and the Dutch system. In the Netherlands, patients are undergoing fast track surgery, being discharged from hospital into their home environment within a few days without getting any aftercare. In Germany, patients stay in hospital for about 12 days before being transferred to a rehabilitation center for another period of three weeks. Subsequently, most patients also get outpatient rehabilitation. The superficially more cost effective Dutch system of postoperative usual care in THA is judged critically in Germany and the Netherlands due to suboptimal rehabilitation. The primary aim of this study is therefore to compare the Dutch vs. German usual care rehabilitation after primary THA in the sense of prosthesis functionality, patient satisfaction and preservation of ability to work. Those parameters will be evaluated by the means of different questionnaires and functional tests. Additionally, long-term economic aspects in both countries will be evaluated from a societal perspective, to get a first impression on whether cutting costs for rehabilitation, as practiced in the Netherlands, really disburdens the health-care system efficiently. Study participants are working-aged patients (18-65 years of age) with clinical and radiological proof of hip OA, who will electively be provided with a primary THA. Additionally, eligible patients on the German side have to agree to do their rehabilitation as an inpatient procedure in the collaborating rehabilitation center. It is hypothesized, that the German postoperative THA usual care rehabilitation is more effective regarding functional outcomes and patient satisfaction than the Dutch procedure. Furthermore, it is hypothesized that the German usual care after primary THA is more cost effective in the long run than the Dutch system.

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Brief Summary in Scientific Language

Osteoarthritis (OA) is the most common joint disorder in the world. In end stage hip OA, surgical implantation of a Total Hip Arthroplasty (THA) is considered one of the most (cost) effective treatments. Due to projected growth of the older population and obesity epidemic, the number of THAs is expected to increase dramatically in the coming decades. Usual postoperative rehabilitation after primary THA differs between the German and the Dutch system. In the Netherlands, patients are undergoing fast track surgery, being discharged from hospital into their home environment within a few days without getting any aftercare. In Germany, patients stay in hospital for about one week before being transferred to a rehabilitation center for another period of three weeks. From the Dutch system it is known that the quick transfer into home environment leads to suboptimal rehabilitation thus in the long run leading to a socio-economic problem. To tackle this problem more evaluation of the current system is mandatory to e.g. gather solid arguments towards the Dutch health care insurances. The aim of this study is therefore to compare the Dutch vs. Germany usual care rehabilitation after THA. It is hypothesized, that the German post-surgical THA intervention is more effective concerning (1) functional outcomes, (2) patient satisfaction, and (3) long-term economic aspects. In order to determine the medical effectiveness both self-reported (HOOS, SF-36, PASS) and objective assessments (Timed up and Go Test (TUG), 5 Timed Sit to Stand Test (5-TSST)) will be applied. Measurements will be performed pre-surgical (T0), at 4 weeks (T1) and 12 weeks (T2) as well as 6 months (T3) post-surgical. In addition, an economic evaluation will be conducted form a societal perspective - costs within and outside the healthcare sector will be registered.

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Organizational Data

  •   DRKS00011345
  •   2016/11/18
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  •   yes
  •   Approved
  •   2874-2015, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

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Health Condition or Problem studied

  •   M16.0 -  Primary coxarthrosis, bilateral
  •   M16.1 -  Other primary coxarthrosis
  •   M16.2 -  Coxarthrosis resulting from dysplasia, bilateral
  •   M16.3 -  Other dysplastic coxarthrosis
  •   M16.6 -  Other secondary coxarthrosis, bilateral
  •   M16.7 -  Other secondary coxarthrosis
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Interventions/Observational Groups

  •   The German cohort is the intervention group. After THA surgery, the patients stay for 3 weeks in a inpatient rehabilitation clinic. Evaluation of medical effectiveness takes place pre-operative, 4 weeks and 12 weeks post-operative utilizing EQ-5D, SF-36, HOOS, PASS, and questions regarding lifestyle. Additionally, functional tests ("Timed up and Go" and "5-Times Sit to Stand Test") will be conducted. A follow-up will take place at 6 months post-operative utilizing the same measurements. In addition, an economic evaluation will be conducted form a societal perspective - costs within and outside the healthcare sector will be registered pre- operative and 6 months post-operative.
  •   The Dutch cohort is the control group. Those patients get no rehabilitation after their THA surgery. Evaluation of medical effectiveness takes place pre-operative, 4 weeks and 12 weeks post-operative utilizing EQ-5D, SF-36, HOOS, PASS, and questions regarding lifestyle. Additionally, functional tests ("Timed up and Go" and "5-Times Sit to Stand Test") will be conducted. A follow-up will take place at 6 months post-operative utilizing the same measurements. In addition, an economic evaluation will be conducted form a societal perspective - costs within and outside the healthcare sector will be registered pre- operative and 6 months post-operative.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

In order to determine the medical effectiveness both self-reported (HOOS, SF-36, PASS) and objective assessments (Timed up and Go Test (TUG), 5 Timed Sit to Stand Test (5-TSST)) will be applied. Measurements will be performed pre-surgical (T0), at 4 weeks (T1) and 12 weeks (T2) as well as 6 months (T3) post-surgical.

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Secondary Outcome

Economic evaluation from a societal perspective. Direct and indirect costs will be evaluated. Evaluation will take place via settlement data from the hospitals (DRG/DGC)/rehab center (daily rates) and with a cost evaluation questionnaire. In that, patients are asked to provide information regarding
absenteeism due to hip related problems, necessity and frequency of visiting a doctor, use of pain medication, time to resumption of work, volume of employment, change of work or retraining (if any), early retirement etc.

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Countries of Recruitment

  •   Germany
  •   Netherlands
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2016/05/12
  •   150
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

(1) Patients are aged between 18-65, (2) showing clinical evidence of hip OA according to Altman et al. (1991), (3) showing radiological evidence of hip OA according to the Hellgren & Lawrence scale grade 1-3, (4) implantation of a Total Hip Arthroplasty (THA), (5) willing to go to a inpatient rehabiliation clinic (German cohort)

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Exclusion Criteria

Patients will be excluded form the study if they are (1) suffering from medical conditions that disallow safe participation in a rehab program (2) cognitive impaired, (3) not able to read and understand German or Dutch, (4) participation on another scientific research in the previous 30 days, (5) participation on another scientific research in the same time.

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Addresses

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    • Universitätsklinik für Orthopädie und Unfallchirurgie am medizinischen Campus am Pius-Hospital
    • Mr.  Prof. Dr. med. habil.  Djordje  Lazovic 
    • Georgstr. 12
    • 16121  Oldenburg
    • Germany
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    • University Medical Center Groningen; Department of Orthopedics;Secretariaat Orthopedie BB51
    • Mr.  Dr.  Martin  Stevens 
    • Hanzeplein 1
    • 9713 GZ  Groningen
    • Netherlands
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    • Universitätsklinik für Orthopädie und Unfallchirurgie am medizinischen Campus im Pius-Hospital
    • Mr.  Prof. Dr. med. habil.   Djordje  Lazovic 
    • Georgstrasse 12
    • 26121  Oldenburg
    • Germany
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    • Universitätsklinik für Orthopädie und Unfallchirurgie am medizinischen Campus im Pius-Hospital
    • Ms.  Gesine  Seeber (MSc) 
    • Georgstrasse 12
    • 26121  Oldenburg
    • Germany
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    • University Medical Center Groningen; Department of Orthopedics; Secretariaat Orthopedie BB51
    • Ms.  Annet  Wijnen (MSc) 
    • Hanzeplein 1
    • 9713 GZ  Groningen
    • Netherlands
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Sources of Monetary or Material Support

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    • Medizinische Fakultät der Carl von Ossietzky Universität Oldenburg (Mittel aus dem Forschungspool der Fakultät)
    • Carl-von-Ossietzky-Str. 9-11
    • 26129   Oldenburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.