Trial Outcomes & Findings for TOKA: Custom Made Devices for High Tibial Osteotomy (HTO)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

At 6 months after surgery

Results posted on

2025-08-03

Participant Flow

Participant milestones

Participant milestones
Measure	Interventional Patient Patients selected and operated for personalised High Tibial Ostotomy (HTO) using theTOKA®
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

TOKA: Custom Made Devices for High Tibial Osteotomy (HTO) - Clinical Investigation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Interventional Patient n=25 Participants Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®)
Age, Continuous	54.4 years STANDARD_DEVIATION 7.4 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	25 Participants n=5 Participants
Body Mass Index	26.8 kg/m2 STANDARD_DEVIATION 4.0 • n=5 Participants

PRIMARY outcome

Timeframe: At 6 months after surgery

Population: Operated Patients

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.

Outcome measures

Outcome measures
Measure	Interventional Patient n=25 Participants Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®) High Tibial Osteotomy: Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®)
Morphology Assessment Via Correction Angle Assessment	1.5 Degree Standard Deviation 2.0

PRIMARY outcome

Timeframe: At 6 months after surgery

Population: Operated patients

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.

Outcome measures

Outcome measures
Measure	Interventional Patient n=25 Participants Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®) High Tibial Osteotomy: Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®)
Morphology Assessment Via Hip-knee-ankle Angle Assessment	1.5 Degree Standard Deviation 2.0

PRIMARY outcome

Timeframe: At 6 months after surgery

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.

Outcome measures

Outcome measures
Measure	Interventional Patient n=25 Participants Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®) High Tibial Osteotomy: Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®)
Morphology Assessment Via Mikulicz Point Assessment	-9.7 % of medial-lateral tibial plateau width Standard Deviation 8.4

PRIMARY outcome

Timeframe: At 6 months after surgery

Population: Operated patiemts

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.

Outcome measures

Outcome measures
Measure	Interventional Patient n=25 Participants Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®) High Tibial Osteotomy: Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®)
Morphology Assessment Via Posterior Slope Assessment	0.1 Degree Standard Deviation 0.3

SECONDARY outcome

Timeframe: Before surgery

Population: Operated Patients - Max Knee Flexion Rotation

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)..

Outcome measures

Outcome measures
Measure	Interventional Patient n=25 Participants Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®) High Tibial Osteotomy: Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®)
Functional Assessment Via Gait Analysis - Kinematics	70.5 Degree Standard Deviation 5.0

SECONDARY outcome

Timeframe: Before surgery

Population: Operated Patients - Max Abduction Moment

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).

Outcome measures

Outcome measures
Measure	Interventional Patient n=25 Participants Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®) High Tibial Osteotomy: Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®)
Functional Assessment Via Gait Analysis - Kinetics	3.8 % of Body Weight * height Standard Deviation 1.2

SECONDARY outcome

Timeframe: 6 months after surgery.

Population: Operated patients - KOOS (total) at 6 month after surgery

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.

Outcome measures

Outcome measures
Measure	Interventional Patient n=25 Participants Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®) High Tibial Osteotomy: Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®)
Functional Assessment Via Clinical Scoring - Knee Osteoarthritis Outcome Score	81.2 score on a scale Standard Deviation 9.7

SECONDARY outcome

Timeframe: 6 months after surgery.

Population: Operated patients - European Quality of life via 5-Dimensions questionnaire (total) at 6 month after surgery

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).

Outcome measures

Outcome measures
Measure	Interventional Patient n=25 Participants Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®) High Tibial Osteotomy: Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®)
Functional Assessment Via Clinical Scoring - European Quality of Life Via 5-Dimensions Questionnaire	7.5 units on scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: 6 month after surgery.

Population: Pot operative patients at 6 month after surgery

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.

Outcome measures

Outcome measures
Measure	Interventional Patient n=25 Participants Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®) High Tibial Osteotomy: Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®)
Functional Assessment Via Clinical Scoring - Tegner Score	4.2 score on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: 6 months after surgery.

Population: Operated patients - KSS (total) at 6 months after surgery

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.

Outcome measures

Outcome measures
Measure	Interventional Patient n=25 Participants Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®) High Tibial Osteotomy: Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®)
Functional Assessment Via Clinical Scoring - Knee Society System Score	93.5 score on a scale Standard Deviation 13.7

SECONDARY outcome

Timeframe: 6 months after surgery.

Population: Operated patients - VAS at 6 month after surgery

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)

Outcome measures

Outcome measures
Measure	Interventional Patient n=25 Participants Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®) High Tibial Osteotomy: Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®)
Functional Assessment Via Clinical Scoring - Visual Analogue Scale	1.3 score on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: Before surgery and at 1, 3, 6, 12 and 24 months after surgery.

Population: Operated patients at 6 months after surgery

The functional assessment is performed via x-ray examinations by reporting knee joint alligments in degrees..

Outcome measures

Outcome measures
Measure	Interventional Patient n=25 Participants Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®) High Tibial Osteotomy: Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®)
The Functional Assessment Via X-ray Examinations	181.9 Degree Standard Deviation 2.6

SECONDARY outcome

Timeframe: 6 months after surgery

Population: Operated Patients - Max Knee Flexion Rotation at 6 months after surgery

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)..

Outcome measures

Outcome measures
Measure	Interventional Patient n=25 Participants Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®) High Tibial Osteotomy: Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®)
Functional Assessment Via Gait Analysis - Kinematics	58 Degree Standard Deviation 6.0

SECONDARY outcome

Timeframe: at 6 months after surgery

Population: Operated Patients - Max Abduction Moment

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).

Outcome measures

Outcome measures
Measure	Interventional Patient n=25 Participants Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®) High Tibial Osteotomy: Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®)
Functional Assessment Via Gait Analysis - Kinetics	2.8 % of Body Weight * height Standard Deviation 0.8

Adverse Events

Interventional Patient

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Stefano Zaffagnini

IRCCS Istituto Ortopedico Rizzoli

Phone: +3905163665706366111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Trial Outcomes & Findings for TOKA: Custom Made Devices for High Tibial Osteotomy (HTO) - Clinical Investigation (NCT NCT04574570)

Results Overview

Participant Flow

Participant milestones

Reasons for withdrawal

Baseline Characteristics

Baseline characteristics by cohort

PRIMARY outcome

Outcome measures

PRIMARY outcome

Outcome measures

PRIMARY outcome

Outcome measures

PRIMARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

SECONDARY outcome

Outcome measures

Adverse Events

Interventional Patient

Serious adverse events

Other adverse events

Additional Information

Dr Stefano Zaffagnini

Results disclosure agreements