Institutional Review Board, Hospital for Special Surgery
February 14, 2008
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
This is a Pilot Study of 10 patients approximately ages 50-80
Bilateral long leg hip to ankle examination and non-weight bearing cross-sectional imaging (CT) of the affected limb will be preformed on the hip, knee and ankle according to the attached protocol as standard of care currently used for surgical planning. Weight-bearing cross sectional imaging of the hip, knee and ankle of the affected extremity will be performed using the Philips MultiDiagnostic Eleva with 3 D imaging following a similar CT protocol. These methods will be compared for diagnostic information and for variations in angulation and alignment accuracy in surgical planning..
Inclusion criteria: Patients who are candidates for unicondylar knee resurfacing with surgical robotics (Makoplasty). Candidates for unicondylar knee resurfacing will have the following:
Medial compartment radiographic DJD
Medial compartment symptoms of one or more of the following:
Medial sided pain, standing pain, difficulty ambulating)
Preservation of lateral and patellofemoral cartilage (on MRI or by arthroscopy)
Less than 10 degree flexion contracture
Varus deformity correctable to neutral alignment and be between the ages of 50-80
Exclusion criteria: Patients with hardware that may obscure imaging of the lower extremity. Unable to stand without assistance. Patients unable to give
informed consent. Patients who are pregnant. Patients whom are under the age of 18.