Knee Osteoarthritis Clinical Trial
Official title:
Minimal vs. Conventional Exposure in Unicompartmental Knee Arthroplasty
Verified date | October 2009 |
Source | University Hospital Orebro |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Medical Products Agency |
Study type | Interventional |
The purpose of this study is to determine whether Minimal Invasive Surgery results in less postoperative pain and better mobilization than conventional technique in Unicompartmental Knee Arthroplasty, provided that both groups receive Local Infiltration Analgesia.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | September 2011 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Patients scheduled for unicompartmental knee arthroplasty - Aged 20-80 yrs - ASA physical status I-III and mobility indicating normal postoperative mobilization Exclusion Criteria: - Known allergy or intolerance to local anesthetics, ASA or NSAID - Serious liver-, heart- or renal decease - Rheumatoid arthritis - Chronic pain or bleeding disorder |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | Dept. of Orthopedic Surgery | Orebro |
Lead Sponsor | Collaborator |
---|---|
University Hospital Orebro |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to fulfilling discharge criteria | 0-2 weeks | No | |
Secondary | Pain intensity | 0-3 months | No | |
Secondary | Hospital stay | 0-2 weeks | No | |
Secondary | Morphine consumption | 0-48 hours | No | |
Secondary | Knee function | 0-3 months | No | |
Secondary | Patient satisfaction | 0-3 months | No |
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