Preoperative Pain, Function, and Activity for Total Hip and Knee Arthroplasty Patients
This study has been completed.
Sponsor:
Hvidovre University Hospital
Collaborator:
Lundbeck Foundation
Information provided by (Responsible Party):
Bente Holm, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01248039
First received: November 24, 2010
Last updated: July 18, 2012
Last verified: July 2012
| Tracking Information | |||||
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| First Received Date ICMJE | November 24, 2010 | ||||
| Last Updated Date | July 18, 2012 | ||||
| Start Date ICMJE | January 2011 | ||||
| Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Leg muscles strength [ Time Frame: 7 months ] [ Designated as safety issue: No ] Maximal muscle force tested for one leg at a time in a Power Rig Mashine |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01248039 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Functional performance [ Time Frame: 7 months ] [ Designated as safety issue: No ] Tested by: Timed Up & Go test, 10 meter fast speed walking test |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Preoperative Pain, Function, and Activity for Total Hip and Knee Arthroplasty Patients | ||||
| Official Title ICMJE | The Influence of Preoperative Pain, Function, and Activity on Time to Fulfill Discharge Criteria for Total Hip and Knee Arthroplasty Patients | ||||
| Brief Summary | This study wish to show if the preoperative level of pain, function or activity for hip and knee arthroplasty patients has any predictive value of the time it takes to fulfill the well-defined discharge criteria. |
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| Detailed Description | The investigators would like to be able to identify those patients, for whom it will take longest time to fulfill the discharge criteria. With this knowledge the investigators will be able to initiate sufficient treatment already before operation. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Concesutive hip and knee arthroplasty patients from a department of orthopaedic surgery |
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| Condition ICMJE | Arthroplasty | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Total arthroplasty
Patients with osteoarthrosis going for hip or knee arthroplasty |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Completion Date | July 2012 | ||||
| Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01248039 | ||||
| Other Study ID Numbers ICMJE | H-4-2010-FSP2, PRE-THA-TKA | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Bente Holm, Hvidovre University Hospital | ||||
| Study Sponsor ICMJE | Hvidovre University Hospital | ||||
| Collaborators ICMJE | Lundbeck Foundation | ||||
| Investigators ICMJE |
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| Information Provided By | Hvidovre University Hospital | ||||
| Verification Date | July 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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