Back to resultsTOKA: Custom Made Devices for High Tibial Osteotomy (HTO) - Clinical Investigation (TOKA)
Primary Purpose
Unicompartmental Medial Knee Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
High Tibial Osteotomy
Sponsored by
About this trial
This is an interventional treatment trial for Unicompartmental Medial Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing opening wedge Hight Tibial Osteotomy (HTO)
- Patients must have completed a consent form for the study
- Patients must be prepared to comply with the pre and post-operative investigations, rehabilitation, attendance schedule and questionnaire schedule of the study
- Patient in whom any varus deformity present is <20°
- The diagnosis is of unicompartmental medial osteoarthritis of the knee
- Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD)
- BMI<40
- Age range 40 to 65 years
Exclusion Criteria:
- Refusal to consent to the study
- Pregnancy
- Prisoners
- A patient known to have substance abuse or psychological disorders that could interfere with their ability to comply with the post-operative rehabilitation and assessment schedules
- Patients unable to read or understand the patient information leaflet and consent form
- Patient has a known sensitivity to device materials.
- Patient has a Body Mass Index (BMI) ≥ 40.
- Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
- Patient has received any orthopaedic surgical intervention to the lower extremities within the past year or is expected to require any orthopaedic surgical intervention to the lower extremities, other than the HTO to be enrolled in this study, within the next year.
- Patient requires bilateral HTO or has a history of unsuccessful contralateral partial replacement or HTO.
- Patient has chronic heart failure (NYHA Stage ≥ 2)
- Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
- Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's disease) leading to progressive bone deterioration.
- Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
Sites / Locations
- IRCCS Istituto Ortopedico RizzoliRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
interventional patient
Arm Description
Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®)
Outcomes
Primary Outcome Measures
Morphology Assessment via correction angle assessment
The device morphology assessment is performed by verifying the matching between the planned correction and the post-operative imaging results, along with the investigation of the maintenance of the desired correction at the follow-up meetings. These results are measured through the correction angle, using image-based techniques.
Morphology Assessment via hip-knee-ankle angle assessment
The device morphology assessment is performed by verifying the matching between the planned correction and the post-operative imaging results, along with the investigation of the maintenance of the desired correction at the follow-up meetings. These results are measured through the hip-knee-ankle angle (HKA - mechanical axis) reported in degree, using image-based techniques.
Morphology Assessment via Mikulicz point assessment
The device morphology assessment is performed by verifying the matching between the planned correction and the post-operative imaging results, along with the investigation of the maintenance of the desired correction at the follow-up meetings. These results are measured through the Mikulicz point reported in % of the tibial width from the medial to the lateral region, using image-based techniques.
Morphology Assessment via posterior slope assessment
The device morphology assessment is performed by verifying the matching between the planned correction and the post-operative imaging results, along with the investigation of the maintenance of the desired correction at the follow-up meetings. These results are measured through the posterior slope reported in degree, using image-based techniques.
Secondary Outcome Measures
Functional Assessment via gait analysis - kinematics
The functional assessment is performed via three dimensional gait analysis of the patients before and after surgery. Relevant kinematic results are reported in terms of joint rotations (in degrees)..
Functional Assessment via gait analysis - kinetics
The functional assessment is performed via three dimensional gait analysis of the patients before and after surgery. Relevant kinematic results are reported in terms of joint moments (in N*mm, normalized to patient's body weight times height).
Functional Assessment via clinical scoring - Knee Osteoarthritis Outcome Score
The functional assessment is performed via clinical scoring using the Knee Osteoarthritis Outcome Score (KOOS). KOOS value range: [min / max]= 0 - 100, higher values mean better outcome.
Functional Assessment via clinical scoring - European Quality of life via 5-Dimensions questionnaire
The functional assessment is performed via clinical scoring using the European Quality of life via 5-Dimensions questionnaire (EQ-5D). In applied EQ-5D, the respondents classify their own health status into 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with 3 levels of severity (no problems, moderate problems, or severe problems. Based on that, patients could be classified into 243 health states and 2 additional states (unconscious and dead). The EQ-5D health states are converted into a single summary score by applying weights to each of the levels in each dimension, as is typically done in cost utility analysis. Health state index scores range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility.
Functional Assessment via clinical scoring - Tegner score
The functional assessment is performed via clinical scoring using the Tegner score. Tegner scale value range: [min / max]= 0 - 10, higher values mean better outcome.
Functional Assessment via clinical scoring - Knee Society System Score
The functional assessment is performed via clinical scoring using the knee society system score (KSS). KSS value range: [min / max]= 0 - 100, higher values mean better outcome.
Functional Assessment via clinical scoring - Visual Analogue Scale
The functional assessment is performed via clinical scoring using the Visual Analogue Scale (VAS). VAS is based on a 10-cm long straight line with one end meaning no pain and the other end meaning the worst pain; on this line, patients are asked to mark a point that matches the amount of pain they feel; the quantification of the point location with respect to the two ends is representative of the ammount of pain.
The functional assessment ivia x-ray examinations
The functional assessment is performed via x-ray examinations by reporting knee joint alligments in degrees..
Full Information
NCT ID
NCT04574570
First Posted
September 10, 2020
Last Updated
January 12, 2021
Sponsor
3D Metal Printing Ltd
Collaborators
University of Bath
1. Study Identification
Unique Protocol Identification Number
NCT04574570
Brief Title
TOKA: Custom Made Devices for High Tibial Osteotomy (HTO) - Clinical Investigation
Acronym
TOKA
Official Title
Clinical Evaluations of the TOKA Customized Device for High Tibial Osteotomy in the Treatment of Knee Osteoarthritis: a Pilot Study.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 14, 2020 (Actual)
Primary Completion Date
May 31, 2021 (Anticipated)
Study Completion Date
November 29, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
3D Metal Printing Ltd
Collaborators
University of Bath
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This preliminary pilot study is a single-centre, prospective, uncontrolled, 32-month study to assess the performance of personalised opening wedge High Tibial Osteotomy (HTO) treatment using the TOKA® device and procedure.
The medical device being examined is a custom-made device and therefore does not require a CE mark. Furthermore, the study will serve as a useful method of gathering clinical data and measuring device performance, as well as establishing a potential commercial relationship with the hospital administration.
Study Objectives::
to assess the morphology of the knee joint and the improvement of OA following the TOKA® treatment.
to Assess the functional outcome of the knee joint and the improvement of OA following the TOKA® treatment.
Outcomes Evaluations::
The morphology of the knee joint is assessed by verifying the matching between the planned correction and the post-operative imaging results, along with the investigation of the maintenance of the desired correction at the follow-up meetings. These results are measured through the correction angle, hip-knee-ankle angle (HKA - mechanical axis), Mikulicz point (recorded as a percentage of the tibial width from the medial to the lateral region) and posterior slope, using the imaging techniques.
The functional outcome of the knee joint is assessed by a) performing a gait analysis of the patients pre-operatively and post-operatively, b) the use of clinical scoring...
.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unicompartmental Medial Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
interventional patient
Arm Type
Other
Arm Description
Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®)
Intervention Type
Device
Intervention Name(s)
High Tibial Osteotomy
Intervention Description
Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®)
Primary Outcome Measure Information:
Title
Morphology Assessment via correction angle assessment
Description
The device morphology assessment is performed by verifying the matching between the planned correction and the post-operative imaging results, along with the investigation of the maintenance of the desired correction at the follow-up meetings. These results are measured through the correction angle, using image-based techniques.
Time Frame
At 6 months after surgery
Title
Morphology Assessment via hip-knee-ankle angle assessment
Description
The device morphology assessment is performed by verifying the matching between the planned correction and the post-operative imaging results, along with the investigation of the maintenance of the desired correction at the follow-up meetings. These results are measured through the hip-knee-ankle angle (HKA - mechanical axis) reported in degree, using image-based techniques.
Time Frame
At 6 months after surgery
Title
Morphology Assessment via Mikulicz point assessment
Description
The device morphology assessment is performed by verifying the matching between the planned correction and the post-operative imaging results, along with the investigation of the maintenance of the desired correction at the follow-up meetings. These results are measured through the Mikulicz point reported in % of the tibial width from the medial to the lateral region, using image-based techniques.
Time Frame
At 6 months after surgery
Title
Morphology Assessment via posterior slope assessment
Description
The device morphology assessment is performed by verifying the matching between the planned correction and the post-operative imaging results, along with the investigation of the maintenance of the desired correction at the follow-up meetings. These results are measured through the posterior slope reported in degree, using image-based techniques.
Time Frame
At 6 months after surgery
Secondary Outcome Measure Information:
Title
Functional Assessment via gait analysis - kinematics
Description
The functional assessment is performed via three dimensional gait analysis of the patients before and after surgery. Relevant kinematic results are reported in terms of joint rotations (in degrees)..
Time Frame
Before surgery and at 6 months after surgery
Title
Functional Assessment via gait analysis - kinetics
Description
The functional assessment is performed via three dimensional gait analysis of the patients before and after surgery. Relevant kinematic results are reported in terms of joint moments (in N*mm, normalized to patient's body weight times height).
Time Frame
Before surgery and at 6 months after surgery
Title
Functional Assessment via clinical scoring - Knee Osteoarthritis Outcome Score
Description
The functional assessment is performed via clinical scoring using the Knee Osteoarthritis Outcome Score (KOOS). KOOS value range: [min / max]= 0 - 100, higher values mean better outcome.
Time Frame
Before surgery and at 1, 3, 6, 12 and 24 months after surgery.
Title
Functional Assessment via clinical scoring - European Quality of life via 5-Dimensions questionnaire
Description
The functional assessment is performed via clinical scoring using the European Quality of life via 5-Dimensions questionnaire (EQ-5D). In applied EQ-5D, the respondents classify their own health status into 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with 3 levels of severity (no problems, moderate problems, or severe problems. Based on that, patients could be classified into 243 health states and 2 additional states (unconscious and dead). The EQ-5D health states are converted into a single summary score by applying weights to each of the levels in each dimension, as is typically done in cost utility analysis. Health state index scores range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility.
Time Frame
Before surgery and at 1, 3, 6, 12 and 24 months after surgery.
Title
Functional Assessment via clinical scoring - Tegner score
Description
The functional assessment is performed via clinical scoring using the Tegner score. Tegner scale value range: [min / max]= 0 - 10, higher values mean better outcome.
Time Frame
Before surgery and at 1, 3, 6, 12 and 24 months after surgery.
Title
Functional Assessment via clinical scoring - Knee Society System Score
Description
The functional assessment is performed via clinical scoring using the knee society system score (KSS). KSS value range: [min / max]= 0 - 100, higher values mean better outcome.
Time Frame
Before surgery and at 1, 3, 6, 12 and 24 months after surgery.
Title
Functional Assessment via clinical scoring - Visual Analogue Scale
Description
The functional assessment is performed via clinical scoring using the Visual Analogue Scale (VAS). VAS is based on a 10-cm long straight line with one end meaning no pain and the other end meaning the worst pain; on this line, patients are asked to mark a point that matches the amount of pain they feel; the quantification of the point location with respect to the two ends is representative of the ammount of pain.
Time Frame
Before surgery and at 1, 3, 6, 12 and 24 months after surgery.
Title
The functional assessment ivia x-ray examinations
Description
The functional assessment is performed via x-ray examinations by reporting knee joint alligments in degrees..
Time Frame
Before surgery and at 1, 3, 6, 12 and 24 months after surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing opening wedge Hight Tibial Osteotomy (HTO)
Patients must have completed a consent form for the study
Patients must be prepared to comply with the pre and post-operative investigations, rehabilitation, attendance schedule and questionnaire schedule of the study
Patient in whom any varus deformity present is <20°
The diagnosis is of unicompartmental medial osteoarthritis of the knee
Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD)
BMI<40
Age range 40 to 65 years
Exclusion Criteria:
Refusal to consent to the study
Pregnancy
Prisoners
A patient known to have substance abuse or psychological disorders that could interfere with their ability to comply with the post-operative rehabilitation and assessment schedules
Patients unable to read or understand the patient information leaflet and consent form
Patient has a known sensitivity to device materials.
Patient has a Body Mass Index (BMI) ≥ 40.
Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
Patient has received any orthopaedic surgical intervention to the lower extremities within the past year or is expected to require any orthopaedic surgical intervention to the lower extremities, other than the HTO to be enrolled in this study, within the next year.
Patient requires bilateral HTO or has a history of unsuccessful contralateral partial replacement or HTO.
Patient has chronic heart failure (NYHA Stage ≥ 2)
Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's disease) leading to progressive bone deterioration.
Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefano Zaffagnini, Professor
Phone
+390516366075
Email
stefano.zaffagnini@ior.it
First Name & Middle Initial & Last Name or Official Title & Degree
Claudio Belvedere, PhD
Phone
+390516366570
Email
belvedere@ior.it
Facility Information:
Facility Name
IRCCS Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Zaffagnini, Professor
Phone
+390516366075
Email
stefano.zaffagnini@ior.it
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
18450624
Citation
Akizuki S, Shibakawa A, Takizawa T, Yamazaki I, Horiuchi H. The long-term outcome of high tibial osteotomy: a ten- to 20-year follow-up. J Bone Joint Surg Br. 2008 May;90(5):592-6. doi: 10.1302/0301-620X.90B5.20386.
Results Reference
background
PubMed Identifier
18764949
Citation
Bedson J, Croft PR. The discordance between clinical and radiographic knee osteoarthritis: a systematic search and summary of the literature. BMC Musculoskelet Disord. 2008 Sep 2;9:116. doi: 10.1186/1471-2474-9-116.
Results Reference
background
PubMed Identifier
24584646
Citation
Elson DW, Petheram TG, Dawson MJ. High reliability in digital planning of medial opening wedge high tibial osteotomy, using Miniaci's method. Knee Surg Sports Traumatol Arthrosc. 2015 Jul;23(7):2041-8. doi: 10.1007/s00167-014-2920-x. Epub 2014 Mar 1.
Results Reference
background
PubMed Identifier
30861539
Citation
Ren YM, Duan YH, Sun YB, Yang T, Hou WY, Zhu RS, Tian MQ. Opening-Wedge High Tibial Osteotomy Using Autograft versus Allograft: A Systematic Review and Meta-analysis. J Knee Surg. 2020 Jun;33(6):565-575. doi: 10.1055/s-0039-1681065. Epub 2019 Mar 12.
Results Reference
background
PubMed Identifier
23477914
Citation
Harris JD, McNeilan R, Siston RA, Flanigan DC. Survival and clinical outcome of isolated high tibial osteotomy and combined biological knee reconstruction. Knee. 2013 Jun;20(3):154-61. doi: 10.1016/j.knee.2012.12.012. Epub 2013 Mar 9.
Results Reference
background
PubMed Identifier
25628282
Citation
Kallala RF, Vanhegan IS, Ibrahim MS, Sarmah S, Haddad FS. Financial analysis of revision knee surgery based on NHS tariffs and hospital costs: does it pay to provide a revision service? Bone Joint J. 2015 Feb;97-B(2):197-201. doi: 10.1302/0301-620X.97B2.33707.
Results Reference
background
PubMed Identifier
13498604
Citation
KELLGREN JH, LAWRENCE JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957 Dec;16(4):494-502. doi: 10.1136/ard.16.4.494. No abstract available.
Results Reference
background
PubMed Identifier
25995491
Citation
Konopka JF, Gomoll AH, Thornhill TS, Katz JN, Losina E. The cost-effectiveness of surgical treatment of medial unicompartmental knee osteoarthritis in younger patients: a computer model-based evaluation. J Bone Joint Surg Am. 2015 May 20;97(10):807-17. doi: 10.2106/JBJS.N.00925.
Results Reference
background
PubMed Identifier
23109632
Citation
Niinimaki TT, Eskelinen A, Mann BS, Junnila M, Ohtonen P, Leppilahti J. Survivorship of high tibial osteotomy in the treatment of osteoarthritis of the knee: Finnish registry-based study of 3195 knees. J Bone Joint Surg Br. 2012 Nov;94(11):1517-21. doi: 10.1302/0301-620X.94B11.29601.
Results Reference
background
PubMed Identifier
26520646
Citation
Smith WB 2nd, Steinberg J, Scholtes S, Mcnamara IR. Medial compartment knee osteoarthritis: age-stratified cost-effectiveness of total knee arthroplasty, unicompartmental knee arthroplasty, and high tibial osteotomy. Knee Surg Sports Traumatol Arthrosc. 2017 Mar;25(3):924-933. doi: 10.1007/s00167-015-3821-3. Epub 2015 Oct 31.
Results Reference
background
PubMed Identifier
26759152
Citation
Verra WC, Witteveen KQ, Maier AB, Gademan MG, van der Linden HM, Nelissen RG. The reason why orthopaedic surgeons perform total knee replacement: results of a randomised study using case vignettes. Knee Surg Sports Traumatol Arthrosc. 2016 Aug;24(8):2697-703. doi: 10.1007/s00167-015-3961-5. Epub 2016 Jan 12.
Results Reference
background
PubMed Identifier
35334334
Citation
Ruggeri M, Gill HS, Leardini A, Zaffagnini S, MacLeod A, Ortolani M, Faccia F, Grassi A, Fabbro GD, Durante S, Belvedere C. Superimposition of ground reaction force on tibial-plateau supporting diagnostics and post-operative evaluations in high-tibial osteotomy. A novel methodology. Gait Posture. 2022 May;94:144-152. doi: 10.1016/j.gaitpost.2022.02.028. Epub 2022 Feb 25.
Results Reference
derived
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TOKA: Custom Made Devices for High Tibial Osteotomy (HTO) - Clinical Investigation
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