Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Bath | OTHER |
Not provided
Not provided
Not provided
Not provided
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::
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...
.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| interventional patient | Other | Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Tibial Osteotomy | Device | Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 6 months after surgery |
| 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. | At 6 months after surgery |
| 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. | At 6 months after surgery |
| 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. | At 6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Assessment Via Gait Analysis - Kinematics | The functional assessment is performed via three dimensional gait analysis of the patients before surgery. Relevant kinematic results are reported in terms of joint rotations (in degrees).. | Before surgery |
| Functional Assessment Via Gait Analysis - Kinetics |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Istituto Ortopedico Rizzoli | Bologna | 40136 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18450624 | Background | 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. | |
| 18764949 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Interventional Patient | Patients selected and operated for personalised High Tibial Ostotomy (HTO) using theTOKA® |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Interventional Patient | Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Operated Patients | Posted | Mean | Standard Deviation | Degree | At 6 months after surgery |
|
24 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Interventional Patient | Patients selected and operated for personalised High Tibial Ostotomy (HTO) using theTOKA® |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Stefano Zaffagnini | IRCCS Istituto Ortopedico Rizzoli | +3905163665706366111 | stefano.zaffagnini@unibo.it |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 7, 2019 | Feb 2, 2024 | Prot_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 7, 2019 | Sep 28, 2020 | ICF_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The functional assessment is performed via three dimensional gait analysis of the patients before surgery. Relevant kinetic results are reported in terms of joint moments (in N*mm, normalized to patient's body weight times height). |
| Before surgery |
| 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. | 6 months after surgery. |
| 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 this applied scoring system, respondents rank their health status into 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be rated from 1 to 3 as follows: 1=no problem, 2=moderate problems or 3=severe problems. The final total score is the sum of the scores given to each dimension and ranges from 5 (best outcome) to 15 (worst outcome). | 6 months after surgery. |
| 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. | 6 month after surgery. |
| 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. | 6 months after surgery. |
| 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. The score is from 0 to 10 (0= no pain, 10= worst pain ever) | 6 months after surgery. |
| The Functional Assessment Via X-ray Examinations | The functional assessment is performed via x-ray examinations by reporting knee joint alligments in degrees.. | Before surgery and at 1, 3, 6, 12 and 24 months after surgery. |
| 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).. | 6 months after surgery |
| 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). | at 6 months after surgery |
| 24584646 | Background | 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. |
| 30861539 | Background | 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. |
| 23477914 | Background | 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. |
| 25628282 | Background | 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. |
| 13498604 | Background | 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. |
| 25995491 | Background | 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. |
| 23109632 | Background | 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. |
| 26520646 | Background | 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. |
| 26759152 | Background | 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. |
| 37562120 | Derived | Zaffagnini S, Dal Fabbro G, Lucidi GA, Agostinone P, Belvedere C, Leardini A, Grassi A. Personalised opening wedge high tibial osteotomy with patient-specific plates and instrumentation accurately controls coronal correction and posterior slope: Results from a prospective first case series. Knee. 2023 Oct;44:89-99. doi: 10.1016/j.knee.2023.07.011. Epub 2023 Aug 8. |
| 35334334 | Derived | 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | 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. | Operated patients | Posted | Mean | Standard Deviation | Degree | At 6 months after surgery |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | % of medial-lateral tibial plateau width | At 6 months after surgery |
|
|
|
| Primary | 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. | Operated patiemts | Posted | Mean | Standard Deviation | Degree | At 6 months after surgery |
|
|
|
| Secondary | Functional Assessment Via Gait Analysis - Kinematics | The functional assessment is performed via three dimensional gait analysis of the patients before surgery. Relevant kinematic results are reported in terms of joint rotations (in degrees).. | Operated Patients - Max Knee Flexion Rotation | Posted | Mean | Standard Deviation | Degree | Before surgery |
|
|
|
| Secondary | Functional Assessment Via Gait Analysis - Kinetics | The functional assessment is performed via three dimensional gait analysis of the patients before surgery. Relevant kinetic results are reported in terms of joint moments (in N*mm, normalized to patient's body weight times height). | Operated Patients - Max Abduction Moment | Posted | Mean | Standard Deviation | % of Body Weight * height | Before surgery |
|
|
|
| Secondary | 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. | Operated patients - KOOS (total) at 6 month after surgery | Posted | Mean | Standard Deviation | score on a scale | 6 months after surgery. |
|
|
|
| Secondary | 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 this applied scoring system, respondents rank their health status into 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be rated from 1 to 3 as follows: 1=no problem, 2=moderate problems or 3=severe problems. The final total score is the sum of the scores given to each dimension and ranges from 5 (best outcome) to 15 (worst outcome). | Operated patients - European Quality of life via 5-Dimensions questionnaire (total) at 6 month after surgery | Posted | Mean | Standard Deviation | units on scale | 6 months after surgery. |
|
|
|
| Secondary | 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. | Pot operative patients at 6 month after surgery | Posted | Mean | Standard Deviation | score on a scale | 6 month after surgery. |
|
|
|
| Secondary | 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. | Operated patients - KSS (total) at 6 months after surgery | Posted | Mean | Standard Deviation | score on a scale | 6 months after surgery. |
|
|
|
| Secondary | 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. The score is from 0 to 10 (0= no pain, 10= worst pain ever) | Operated patients - VAS at 6 month after surgery | Posted | Mean | Standard Deviation | score on a scale | 6 months after surgery. |
|
|
|
| Secondary | The Functional Assessment Via X-ray Examinations | The functional assessment is performed via x-ray examinations by reporting knee joint alligments in degrees.. | Operated patients at 6 months after surgery | Posted | Mean | Standard Deviation | Degree | Before surgery and at 1, 3, 6, 12 and 24 months after surgery. |
|
|
|
| Secondary | 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).. | Operated Patients - Max Knee Flexion Rotation at 6 months after surgery | Posted | Mean | Standard Deviation | Degree | 6 months after surgery |
|
|
|
| Secondary | 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). | Operated Patients - Max Abduction Moment | Posted | Mean | Standard Deviation | % of Body Weight * height | at 6 months after surgery |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
Not provided
Not provided