Medial Compartment Osteoarthritis of the Knee Clinical Trial
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
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 group.The 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
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 (e.g. 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 (i.e. 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01269944 -
Effects of Osteotomies Around the Knee on Cartilage Glycosaminoglycan Content Using dGEMRIC Non-invasive Imaging
|
N/A | |
| Withdrawn |
NCT01614288 -
High Tibial Osteotomy (HTO) With or Without Arthroscopy of the Knee Joint
|
N/A |