Chronic Meniscus Injury Clinical Trial
Official title:
Is a Knee Arthroscopy of Any Benefit for the Middleaged Patient With Meniscal Symptoms?
The purpose of this study is to determine whether a knee arthroscopy is effective in the treatment of middleaged patients with meniscal symptoms also receiving a standardised exercise program.
| Status | Completed |
| Enrollment | 150 |
| Est. completion date | May 2013 |
| Est. primary completion date | May 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 45 Years to 64 Years |
| Eligibility |
Inclusion Criteria: - All (consecutive) patients referred to the orthopaedic department in Linköping for a suspected meniscal injury - Age:45-64 years old - No gonarthrosis (Ahlbäck=0) on standing radiographs Exclusion Criteria: - Rheumatic disease - Patellofemoral arthrosis - Fibromyalgia - A knee or hip replacement - A neurologic disorder including stroke - A contraindication for an operation - Catching or locking for more than 2 seconds more than once a week - A permanent extension deficit - Patients who cannot understand instructions in Swedish |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Orthopaedic dept. University Hospital Linköping | Linköping |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Linkoeping |
Sweden,
Englund M, Guermazi A, Gale D, Hunter DJ, Aliabadi P, Clancy M, Felson DT. Incidental meniscal findings on knee MRI in middle-aged and elderly persons. N Engl J Med. 2008 Sep 11;359(11):1108-15. doi: 10.1056/NEJMoa0800777. — View Citation
Englund M, Roos EM, Roos HP, Lohmander LS. Patient-relevant outcomes fourteen years after meniscectomy: influence of type of meniscal tear and size of resection. Rheumatology (Oxford). 2001 Jun;40(6):631-9. — View Citation
Ericsson YB, Dahlberg LE, Roos EM. Effects of functional exercise training on performance and muscle strength after meniscectomy: a randomized trial. Scand J Med Sci Sports. 2009 Apr;19(2):156-65. doi: 10.1111/j.1600-0838.2008.00794.x. Epub 2008 Apr 6. — View Citation
Herrlin S, Hållander M, Wange P, Weidenhielm L, Werner S. Arthroscopic or conservative treatment of degenerative medial meniscal tears: a prospective randomised trial. Knee Surg Sports Traumatol Arthrosc. 2007 Apr;15(4):393-401. Epub 2007 Jan 10. — View Citation
Larsson AC, Petersson I, Ekdahl C. Functional capacity and early radiographic osteoarthritis in middle-aged people with chronic knee pain. Physiother Res Int. 1998;3(3):153-63. — View Citation
Paradowski PT, Englund M, Roos EM, Lohmander LS. Similar group mean scores, but large individual variations, in patient-relevant outcomes over 2 years in meniscectomized subjects with and without radiographic knee osteoarthritis. Health Qual Life Outcomes. 2004 Jul 27;2:38. — View Citation
Roos EM, Bremander AB, Englund M, Lohmander LS. Change in self-reported outcomes and objective physical function over 7 years in middle-aged subjects with or at high risk of knee osteoarthritis. Ann Rheum Dis. 2008 Apr;67(4):505-10. Epub 2007 Aug 17. — View Citation
Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003 Nov 3;1:64. Review. — View Citation
Roos EM, Roos HP, Ekdahl C, Lohmander LS. Knee injury and Osteoarthritis Outcome Score (KOOS)--validation of a Swedish version. Scand J Med Sci Sports. 1998 Dec;8(6):439-48. — View Citation
Roos EM, Roos HP, Ryd L, Lohmander LS. Substantial disability 3 months after arthroscopic partial meniscectomy: A prospective study of patient-relevant outcomes. Arthroscopy. 2000 Sep;16(6):619-26. — View Citation
Tegner Y, Lysholm J. Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat Res. 1985 Sep;(198):43-9. — View Citation
Wood L, Peat G, Thomas E, Hay EM, Sim J. Associations between physical examination and self-reported physical function in older community-dwelling adults with knee pain. Phys Ther. 2008 Jan;88(1):33-42. Epub 2007 Nov 20. — View Citation
* Note: There are 12 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | KOOS (Knee injury and Osteoarthritis Outcome Score); Pain subscale | KOOS is a 42 item selfadministrated questionnaire with 5 separate subscales; pain, symptoms, activities of daily living (ADL), sport and recreation, quality of life (QoL). A change of approximately 10 is considered a clinical important difference (CID). At 12 month after the randomization the "arthroscopy+exercise therapy" arm will be compared to the "exercise therapy alone" arm. | 12 month | No |
| Secondary | KOOS (Knee injury and Osteoarthritis Outcome Score) | 3 month | No | |
| Secondary | Tegner activity scale | 12 month | No | |
| Secondary | KOOS (Symptoms, ADL, Sport/rec, QOL subscores) | 12 month | No | |
| Secondary | Functional tests | Squatting (possible without pain, possible with pain, not possible). SOLEC ( one-legged stance) barefoot. Best time for three trials. Standing up from a chair on one leg, maximum repetitions in 30 sec. All test supervised by a physiotherapist. | 3 month | No |