Comparison Between TOMOFIX and BodyCAD Fine Osteotomy

KOOS

The KOOS is a 42-item knee-specific questionnaire with five separately reported domains, including pain, other symptoms, function in daily living, function in sports/recreation and knee-related quality of life. Domain scores represent the average of all items in the domain standardized to a score from 0 to 100 (worst to best). This instrument has demonstrated construct validity, excellent test-retest reliability for each domain (range, 0.75 to 0.93) and is responsive to change.

EQ-5D (Index and VAS)

The EuroQoL comprises two sections, the EQ-5D index and the EQ-5D visual analogue scale (VAS). The EQ-5D index is a 5-item standardized generic measure of HRQOL that includes domains of mobility, self-care, usual activities, pain and discomfort and anxiety and depression. Each item is scored using a 5-point response scale and each combination of response choices describes a health state (3125 unique health states). Each health state can be converted to a utility value from 0 (worst) to 1.0 (best) using a scoring formula. The EQ-5D VAS is a 0 (worst) to 100 (best) scale that assesses patient-perceived health status responsiveness among patients undergoing knee arthroscopy.

Procedure Time

To determine the length of the surgery, the timing will be extracted from the intra-operative nursing record, the time of first incision and the time of closing and calculate the amount of time in minutes. To determine the amount of fluoroscopic time, the time will be extracted from image intensifier record the amount of fluoroscopic imaging utilised in the operating room and calculate a total exposure time in seconds.

Adverse Events

All adverse events will be recorded and the relatedness, severity and expectedness to the study protocol will be classified. Plain radiographs will be used at each follow-up to assess for the presence of a hinge fracture and delayed or non-union. Loss of motion/arthrofibrosis will be assessed by a blinded assessor who will measure passive and active knee extension and active-assisted knee flexion with a goniometer. For passive knee extension, the patient will lie supine on the examination table with a bolster under the heels with the quadriceps and hamstrings relaxed to assure full passive extension of the knee. For active-assisted knee flexion, the patient will be seated on the examination table with both legs extended and instructed to perform active-assisted knee flexion by placing one hand under their thigh to initiate flexion and then clasp both hands just below the tibial tuberosity. The side-to-side difference in ROM will be determined and interpreted based on IKDC guidelines.

Cost Effectiveness

Participants who suffer an adverse event will be asked to complete a healthcare resource use diary to capture additional direct and indirect healthcare resources from the time of surgery to the end of the study period. This will include any emergency room visits, hospitalizations, family doctor visits, additional outpatient clinic visits, tests, procedures, prescription or over-the-counter medications and any miscellaneous costs related to their knee. Employment status and time-off paid employment, homemaking or volunteer activities, for both participants and their caregivers, if applicable will be recorded. Quality-adjusted life years (QALYs) using the European Quality of Life Scale (Euro-QoL) will be measured.