Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00158431
Status:
COMPLETED
Last Update Posted:
2015-11-30
First Post:
2005-09-07
Brief Title:
Surgery Versus no Surgery for OA of the Knee
Sponsor:
Fowler Kennedy Sport Medicine Clinic
Organization:
Fowler Kennedy Sport Medicine Clinic
Study Overview
Official Title:
Arthroscopic Surgery Versus Non-surgical Treatment of Osteoarthritis of the Knee
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this trial is to evaluate the effectiveness of arthroscopy lavage and debridement in conjunction with the best available non-surgical treatment versus the best available non-surgical treatment alone medication health education and physical therapy in patients with osteoarthritis of the knee
Detailed Description:
Osteoarthritis is estimated to affect half of the adult population and by the age of 75 years it is anticipated that 85 of 100 elderly patients will have some form of this disease Osteoarthritis OA is characterized by moderate to severe pain that limits functional ability It is suspected that the causes of this debilitating pain include irritation of the synovium excessive subchondral bone forces and raised intra-arterial pressure The knee is the most commonly affected weight-bearing joint Osteoarthritis has a great social impact as the second most common reason for work disability in the United States The prevalence of OA is expected to increase in the coming years due to increased longevity increased proportion of the population over the age of 75 years and increased diagnostic ability
Rather than further evaluations of different forms of arthroscopic surgery ie lavage vs debridement vs abrasion in the treatment of knee OA we feel it is important to establish the efficacy of this technology compared to the best non-surgical treatment alone
This is an evaluator- blinded phase III single-centre group sequential randomized controlled trial in patients with osteoarthritis of the knee
Treatment effectiveness is based upon patients disease specific quality of life at 2 years using the Western Ontario McMaster WOMAC Osteoarthritis Index In addition patients physical function and cost effectiveness are being assessed Costs will be estimated from the perspectives of the health care system the patientfamily and society and will include the use of hospital and other resources as well as the economic implications of lost workdays associated with these alternative treatments
This randomized clinical trial will provide high quality evidence to determine what the role of this expensive treatment is in the overall management of OA
Rather than further evaluations of different forms of arthroscopic surgery ie lavage vs debridement vs abrasion in the treatment of knee OA we feel it is important to establish the efficacy of this technology compared to the best non-surgical treatment alone
This is an evaluator- blinded phase III single-centre group sequential randomized controlled trial in patients with osteoarthritis of the knee
Treatment effectiveness is based upon patients disease specific quality of life at 2 years using the Western Ontario McMaster WOMAC Osteoarthritis Index In addition patients physical function and cost effectiveness are being assessed Costs will be estimated from the perspectives of the health care system the patientfamily and society and will include the use of hospital and other resources as well as the economic implications of lost workdays associated with these alternative treatments
This randomized clinical trial will provide high quality evidence to determine what the role of this expensive treatment is in the overall management of OA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CIHR MCT-15227 | OTHER_GRANT | Canadian Instititute for Health Research | None |