Rehabilitation After Fast-track Total Knee Arthroplasty (HOLEST)
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | April 27, 2010 | ||||
| Last Updated Date | April 4, 2011 | ||||
| Start Date ICMJE | April 2010 | ||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Oxford Knee Score [ Time Frame: Six months postoperatively ] [ Designated as safety issue: No ] A disease specific questionnaire, which measures knee pain and function with 12 items. The questionnaire is sum scored with a range from 0 = worse pain and function to 48 = best pain and function |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01329081 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
EQ-5D [ Time Frame: Twelve months postoperatively ] [ Designated as safety issue: No ] A generic questionnaire, which measures health-related quality-of-life (HRQOL) with 5 items. The questionnaire is scored with a range from -0.55 = worse HRQOL to 1.00 = best HRQOL |
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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 | Rehabilitation After Fast-track Total Knee Arthroplasty | ||||
| Official Title ICMJE | Rehabilitation After Fast-track Total Knee Arthroplasty | ||||
| Brief Summary | BACKGROUND In 2008 approximately 7,700 total knee arthroplasties (TKA) were performed in Denmark. The results after TKA is in general very good, the investigators have, however, discovered that patients following fast-track TKA still have a deficit 12 months postoperatively of 5-10% in health-related quality-of-life and 15-20% in activity and participation when compared to age- and gender matched population. A postoperative rehabilitation intervention has the potential to reduce or remove this observed deficit. The current evidence of postoperative rehabilitation after TKA is, however, scares and conflicting, and no studies have shown a lasting effect beyond 3 months postoperatively. PURPOSE The purpose of this study is to investigate if a 6-weeks postoperative rehabilitation intervention is more effective than supervised home training, and furthermore to investigate the cost-effectiveness of the intervention in a societal perspective. MATERIALS & METHODS The study is performed as a randomized clinical trial. In total 140 patients are included in the study. Inclusion criteria are age above 18 years, patients diagnosed as having knee arthrosis, patients receiving primary elective TKA, and patients who are able to and willing transport themselves to the rehabilitation center, which demands ability to walk 50 meter, and climb 10 stair steps. Exclusion criteria are unicompartmental or revision arthroplasty, any neurological disease, knee infection, and substantial pain or functional limitation hindering rehabilitation tested by physiotherapist prior to rehabilitation start. Primary endpoint is 6 months postoperatively and primary outcome measure is change in total score by using the knee specific questionnaire Oxford Knee Score. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Knee Arthroplasty | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 140 | ||||
| Estimated Completion Date | July 2012 | ||||
| Estimated Primary Completion Date | December 2011 (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 |
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| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01329081 | ||||
| Other Study ID Numbers ICMJE | KL24621 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Kristian Larsen, Ph.D., Associate Professor, Principal Investigator, Orthopedic Research Unit, Hospital Unit West, Denmark | ||||
| Study Sponsor ICMJE | University of Aarhus | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | University of Aarhus | ||||
| Verification Date | April 2011 | ||||
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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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