Osteoarthrosis Clinical Trial
Verified date | February 2014 |
Source | Ziv Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ethics Commission |
Study type | Observational |
Total knee replacement is one of the most commonly performed orthopedic procedures. As of
2010, about 600,000 total knee replacements were being performed annually in the United
States and these numbers are rising. The normal knee joint functions as a complex hinge
allowing primarily flexion and extension, rotation and gliding. The knee joint is made up of
three compartments, the lateral, medial and anterior (patellofemoral). Damage to the
cartilage of one or more compartments may be the result of osteoarthritis (idiopathic or
post-traumatic), inflammatory arthritis (rheumatoid,psoriatic, etc.), a-vascular necrosis,
tumors, or congenital deformities. Osteoarthritis and rheumatoid arthritis are the causes of
the overwhelming majority of total joint arthroplasties.
A successful Total knee arthroplasty(TKA) surgery includes: an accurate alignment( the
mechanical axis in axial and rotational planes), as well as significant pain relief which
improves function and quality of life. Incorrect alignment can lead to abnormal wear,
premature mechanical loosening of the components and patellofemoral problems.
The common techniques for Total knee replacement are:
1. Conventional method TKR
2. CT/MRI-based preoperative navigated TKR
3. Image-free intraoperative navigated TKR In our research we focus on the 3rd method
using the Orthopilot navigation system Aesculap®, Tutlingen, Germany. This system is an
active PC based guiding system that helps the surgeon decide on the accurate alignment
and orientation of the implant and cutting surfaces of the bone and thus avoid
incorrect alignment.
We aim to compare between pre-operative and post-operative lower limb alignment (mechanical
axis) in Aesculap based TKA using serview CT. Furthermore, we will try to examine the
existence of a correlation between the CT scans and the Orthopilot navigation system output
and assess the clinical outcome of the patient postoperatively.
Our Hypothesis is that the intra-operative navigation system is accurate and correlated to
CT images results, moreover, allows the surgeon to achieve a good mechanical axis and high
clinical outcome,
Status | Completed |
Enrollment | 70 |
Est. completion date | January 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - age over 18 - severe osteoarthrosis of the knee - failure of conservative treatment. Exclusion Criteria: - patients with severe vascular disease - secondary knee deformation due to muscular atrophy or disease - active infection - morbid obesity - neuropathic knee and osteomyelitis. |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Israel | ZIV medical center | Safed |
Lead Sponsor | Collaborator |
---|---|
Ziv Hospital |
Israel,
Bargren JH, Blaha JD, Freeman MA. Alignment in total knee arthroplasty. Correlated biomechanical and clinical observations. Clin Orthop Relat Res. 1983 Mar;(173):178-83. — View Citation
Berger RA, Rubash HE, Seel MJ, Thompson WH, Crossett LS. Determining the rotational alignment of the femoral component in total knee arthroplasty using the epicondylar axis. Clin Orthop Relat Res. 1993 Jan;(286):40-7. — View Citation
Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. — View Citation
Mason JB, Fehring T, Fahrbach K. Navigated total knee replacement. J Bone Joint Surg Am. 2007 Nov;89(11):2547-8; author reply 2548; discussion 2548-50. — View Citation
Oswald MH, Jakob RP, Schneider E, Hoogewoud HM. Radiological analysis of normal axial alignment of femur and tibia in view of total knee arthroplasty. J Arthroplasty. 1993 Aug;8(4):419-26. — View Citation
Wasielewski RC, Galante JO, Leighty RM, Natarajan RN, Rosenberg AG. Wear patterns on retrieved polyethylene tibial inserts and their relationship to technical considerations during total knee arthroplasty. Clin Orthop Relat Res. 1994 Feb;(299):31-43. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | limb axis measurement | surview CT images pre-( 1 week before the operation) and post-operatively(the day of operation) will be analyzed using the Traumacad software for limb axis. The navigation system results pre- and post-operatively will be given by the computer as an output at the Operation Theater. The results will be recorded for Varus/Valgus and degrees of deformity. |
An average, 1 week preoperatively up to 3 days postoperatively. | No |
Secondary | Clinical outcome and function | the clinical evaluation of the patient will be based on the knee society scoring system: Range of movement(degrees), pain level(1-lowest,10-highest), anterior-posterior stability(mm), mediolateral stability(degrees), function test based on walking,climbing stairs, use of walking aids. The results will be summed up and give a numerical score. | up to 6 months postoperatively | No |
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