Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00284622
Status:
UNKNOWN
Last Update Posted:
2009-01-29
First Post:
2006-01-31
Brief Title:
HTO With and Without Arthroscopy
Sponsor:
Fowler Kennedy Sport Medicine Clinic
Organization:
Fowler Kennedy Sport Medicine Clinic
Study Overview
Official Title:
A Randomized Clinical Trial to Compare the Effectiveness of High Tibial Osteotomy With or Without Arthroscopy of the Knee Joint on Quality of Life Functional Ability and Pain for Patients With Medical Compartment Osteoarthritis of the Knee
Status:
UNKNOWN
Status Verified Date:
2009-01
Last Known Status:
NOT_YET_RECRUITING
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:
It remains unknown if a concomitant arthroscopic knee debridement would increase the benefits of surgery quality of life and functional ability for young active patients with medial compartment OA of the knee and varus alignmen This additional procedure has a low incidence of morbidity and would potentially allow for treatment of meniscal tears and articular damage as well as joint lavage to remove debris and inflammatory factors A trial is needed to determine whether HTO with concomitant knee arthroscopy will result in better overall outcomes for this patient groupThe objective is to compare the quality of life functional status pain and swelling of patients who undergo an HTO with or without a concomitant knee joint arthroscopy to address additional joint pathology
Detailed Description:
Arthroscopy for degenerative conditions of the knee is among the most widely employed orthopaedic procedures but its effectiveness like the effectiveness of many surgical operations has never been proven in prospective trials The evidence supporting the use of arthroscopy in treatment algorithms for knee OA comes largely from case series and cohort studies These studies have shown that about 50 of patients report pain relief following the procedure Predictors of poor outcome following arthroscopy include marked mal-alignment restricted range of motion advanced radiographic changes and prior surgery Improved outcomes are predicted by preoperative mechanical symptoms caused by loose bodies meniscal tears or radiographic evidence of mild articular degeneration
The proposed study is a randomized clinical trial
Each patient will undergo a preoperative MRI of their affected knee joint to identify existing pathology eg meniscal tears loose bodies chondral flaps The results of the MRI will not be revealed to physicians patients or data collectors This will ensure that we have information on the existing joint pathology within each group and that prognostic variables between groups were sufficiently balanced ie comparable rates of similar pathology per group The primary outcome measure is self-reported quality of life WOMAC Secondary measures include self-reported functional ability LEFS swelling pain and frequency of analgesic use patient diary and general health SF-36 Assessments will take place preoperatively and at 3 6 and 12 months postoperatively
The proposed study is a randomized clinical trial
Each patient will undergo a preoperative MRI of their affected knee joint to identify existing pathology eg meniscal tears loose bodies chondral flaps The results of the MRI will not be revealed to physicians patients or data collectors This will ensure that we have information on the existing joint pathology within each group and that prognostic variables between groups were sufficiently balanced ie comparable rates of similar pathology per group The primary outcome measure is self-reported quality of life WOMAC Secondary measures include self-reported functional ability LEFS swelling pain and frequency of analgesic use patient diary and general health SF-36 Assessments will take place preoperatively and at 3 6 and 12 months postoperatively
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