Osteoarthritis, Knee Clinical Trial
Official title:
Do Patient Specific Implants Improve Accuracy of Correction With MOWHTO. A Pilot Study for a Definitive Randomised Trial Comparing TOMOFIX and BodyCAD Fine Osteotomy.
This is a single centre, randomised, patient blinded pilot study that will assign 40 participants with medial knee osteoarthritis undergoing medial opening wedge high tibial osteotomy (MOWHTO) to either current standard of care with TOMOFIX plating system, or utilise patient specific instrumentation and custom-made plate development, with BodyCAD Fine Osteotomy. If the definitive study is deemed feasible, an additional 110 participants will be randomized, for a total of 150 participants.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | June 2027 |
Est. primary completion date | January 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - aged 18-70 years old - have medial compartment osteoarthritis, with varus alignment, deemed suitable for a MOWHTO - able to speak, read and understand English Exclusion Criteria: - found to have a cruciate ligament deficiency - require multiplanar or rotational alignment correction - have greater than 5 degrees fixed flexion deformity - unable to have CT scans for follow up - evidence of tricompartmental osteoarthritis - evidence of lateral compartment osteoarthritis on arthroscopy - received injection therapy within 3 months of surgery on the operative knee - have a medical history of inflammatory arthropathy, diabetes - actively smoke |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
---|---|
Western University, Canada |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months | |
Secondary | 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. | Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months | |
Secondary | 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. | Surgery | |
Secondary | 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. | Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months | |
Secondary | 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. | Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months |
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