OsteotomyNCT06250530
Comparison Between TOMOFIX and BodyCAD Fine Osteotomy
A study testing High tibial osteotomy using TOMOFIX and High tibial osteotomy using BodyCAD in people with Osteotomy and Malalignment, Bone, run by Western University, Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Osteotomy, Malalignment, Bone, Osteoarthritis, Knee
- What is being tested?
- High tibial osteotomy using TOMOFIX and High tibial osteotomy using BodyCAD
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18-70 years old
- have medial compartment osteoarthritis, with varus alignment, deemed suitable for a MOWHTO
- able to speak, read and understand English
Who cannot join
- 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
Show all 9Show fewer
- received injection therapy within 3 months of surgery on the operative knee
- have a medical history of inflammatory arthropathy, diabetes
- actively smoke
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
The proposed study is a single centre, pilot randomised controlled, patient blinded study that will randomly assign 40 participants with medial knee osteoarthritis undergoing medial opening wedge proximal 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. Participants will follow a standardized rehabilitation protocol. Outcomes will be assessed over two years postoperatively utilising CT assessment for accuracy of correction, bony union and construct stability as well as PROMs including KOOS and EQ5D.
Complications, adverse events, returns to theatre and costs will also be recorded. End of study is defined when the last enrolled subject reaches the 24-month follow-up time point and close-out activities are complete.
If the pilot study demonstrates the feasibility of the definitive trial, an additional 110 participants will be ennrolled, for a total of 150 participants.
- Conditions
- Osteotomy, Malalignment, Bone, Osteoarthritis, Knee
- Being tested
- High tibial osteotomy using TOMOFIX, High tibial osteotomy using BodyCAD
- Medical subject headings
- Bone Malalignment, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High tibial osteotomy using TOMOFIXProcedure or surgery
Also called TOMOFIX
TOMOFIX: A guidepin is placed to determine the level and length of the osteotomy with an appropriate hinge position selected. The oscillating saw is then used along with osteotomes to complete the osteotomy under image intensifier guidance. This is opened to the desired width of correction with a trapezoidal gap noted when using laminar spreader in the posterior position to avoid slope change. The plate is then applied and secured as per manufacturers operative technique.
High tibial osteotomy using BodyCADProcedure or surgery
Also called BodyCAD
BodyCAD: The patient specific cutting block is applied to the proximal tibia and secured in placed. The osteotomy is then created with sequential drills and osteotome and opened to the predetermined correction as per the manufacturer's guidelines. The plate is applied and secured with the supplied screws.
| Study group | Role | What they receive |
|---|---|---|
| BodyCAD | Experimental | For participants randomized to BodyCAD Fine osteotomy, the HKA radiographs and CT scans will be sent to the manufacturer via a secure weblink as per SoC. The films will be used to calculate the desired correction and the instruments and implants manufactured accordingly. The mechanical medial proximal tibial angle (mMPTA) will be recorded for both pre- and planned post-operative situations and used to determine the accuracy of correction (primary outcome). Receives: Procedure: High tibial osteotomy using BodyCAD |
| TOMOFIX | Active comparator | For participants randomized to the TOMOFIX system, preoperative planning will use the HKA radiograph. DICOM images will be transported to MEDICAD software program in which alignment angles and alignment correction will be calculated. The mMPTA will again be utilised to determine the accuracy of correction (primary outcome). The preop CT scan will also be used as per the BodyCAD system and the same indices calculated so as to minimise measurement bias between two different imaging modalities. However, the results of the preoperative 3D CT planning will not be made available to the operating surgeon, again to minimise bias between groups. Receives: Procedure: High tibial osteotomy using TOMOFIX |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months
Secondary outcomes (4)
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.
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months
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.
Measured: Surgery
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.
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months
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.
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study startJul 2024 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The proposed study is a single centre, pilot randomised controlled, patient blinded study that will randomly assign 40 participants with medial knee osteoarthritis undergoing medial opening wedge proximal 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Al Getgood, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250530
- Sponsor's protocol ID
- REB #120983
- Status last verified
- Apr 2024
- First submitted
- 20 Dec 2023
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06250530
- Acronym / sponsor ID
- REB #120983
- Conditions
- Osteotomy, Malalignment, Bone, Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The proposed study is a single centre, pilot randomised controlled, patient blinded study that will randomly assign 40 participants with medial knee osteoarthritis undergoing medial opening wedge proximal 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. Participants will follow a standardized rehabilitation protocol. Outcomes will be assessed over two years postoperatively utilising CT assessment for accuracy of correction, bony union and construct stability as well as PROMs including KOOS and EQ5D.
Complications, adverse events, returns to theatre and costs will also be recorded. End of study is defined when the last enrolled subject reaches the 24-month follow-up time point and close-out activities are complete.
If the pilot study demonstrates the feasibility of the definitive trial, an additional 110 participants will be ennrolled, for a total of 150 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The proposed study is a single centre, pilot randomised controlled, patient blinded study that will randomly assign 40 participants with medial knee osteoarthritis undergoing medial opening wedge proximal 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.
| Arm | Type | Receives |
|---|---|---|
| BodyCAD | Experimental | Procedure: High tibial osteotomy using BodyCADFor participants randomized to BodyCAD Fine osteotomy, the HKA radiographs and CT scans will be sent to the manufacturer via a secure weblink as per SoC. The films will be used to calculate the desired correction and the instruments and implants manufactured accordingly. The mechanical medial proximal tibial angle (mMPTA) will be recorded for both pre- and planned post-operative situations and used to determine the accuracy of correction (primary outcome). |
| TOMOFIX | Active comparator | Procedure: High tibial osteotomy using TOMOFIXFor participants randomized to the TOMOFIX system, preoperative planning will use the HKA radiograph. DICOM images will be transported to MEDICAD software program in which alignment angles and alignment correction will be calculated. The mMPTA will again be utilised to determine the accuracy of correction (primary outcome). The preop CT scan will also be used as per the BodyCAD system and the same indices calculated so as to minimise measurement bias between two different imaging modalities. However, the results of the preoperative 3D CT planning will not be made available to the operating surgeon, again to minimise bias between groups. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 18-70 years old
- have medial compartment osteoarthritis, with varus alignment, deemed suitable for a MOWHTO
- able to speak, read and understand English
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High tibial osteotomy using TOMOFIXAlso: TOMOFIXTOMOFIX: A guidepin is placed to determine the level and length of the osteotomy with an appropriate hinge position selected. The oscillating saw is then used along with osteotomes to complete the osteotomy under image intensifier guidance. This is opened to the desired width of correction with a trapezoidal gap noted when using laminar spreader in the posterior position to avoid slope change. The plate is then applied and secured as per manufacturers operative technique. | Procedure or surgery | TOMOFIX |
| High tibial osteotomy using BodyCADAlso: BodyCADBodyCAD: The patient specific cutting block is applied to the proximal tibia and secured in placed. The osteotomy is then created with sequential drills and osteotome and opened to the predetermined correction as per the manufacturer's guidelines. The plate is applied and secured with the supplied screws. | Procedure or surgery | BodyCAD |
Primary outcome
KOOS
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months
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.
4 secondary outcomes
EQ-5D (Index and VAS)
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months
Procedure Time
Time frame: Surgery
Adverse Events
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months
Cost Effectiveness
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing High tibial osteotomy using TOMOFIX and High tibial osteotomy using BodyCAD in people with Osteotomy and Malalignment, Bone, run by Western University, Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stacey Wanlin (519-661-2111 ext. 82705, swanlin@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KOOS (time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.