ToKa HTO Versus Generic HTO Virtual Clinical Trial

• ClinicalTrials.gov Identifier: NCT03419598
• Recruitment Status: Unknown
• First Posted: February 5, 2018
• Last Update Posted: February 5, 2018
• Sponsor: University of Bath
• Collaborator: Royal Devon and Exeter NHS Foundation Trust
• Information provided by (Responsible Party): Richie Gill, University of Bath

Tracking Information

• First Submitted Date: January 26, 2018
• First Posted Date: February 5, 2018
• Last Update Posted Date: February 5, 2018
• Actual Study Start Date: January 3, 2017
• Estimated Primary Completion Date: June 1, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 26, 2018)

Mechanical stress in plate [ Time Frame: 6 weeks simulated post-operation ]

Mechanical strain calculated for functional loading using finite element analysis

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: January 26, 2018)

Mechanical strain in bone around screws [ Time Frame: 6 weeks simulated post-operation ]

Mechanical strain calculated for functional loading using finite element analysis

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: ToKa HTO Versus Generic HTO Virtual Clinical Trial
• Official Title: ToKa Subject Specific HTO Versus Generic HTO Virtual Clinical Trial

Brief Summary

High Tibial Osteotomy (HTO) is an alternative to knee replacement in suitable patients with early knee osteoarthritis (OA), it is particularly suited to patients with single compart disease who otherwise would be suitable for unicompartmental knee replacement (UKR). OA of the knee is very common and increasing driven by the ageing of the population. The current limitations of HTO are related to the difficulty of achieving the desired correction due to a challenging surgical technique and soft tissue irritation due to the use of generic stabilisation plates. This study will examine the safety equivalence of a new patient specific HTO process which has patient specific 3D printed plates, ToKa, with the existing most commonly used HTO procedure using the Tomofix plate. Importantly this study will be undertaken as a Virtual Trial, existing anonymised 3D imaging data will be used to create the virtual patient cohort. This cohort will receive both procedures, which for this type of procedure is only possible in a virtual scenario.

The main question to be addressed is: "Is the ToKa procedure as safe as the most commonly used existing HTO procedure?". In this context safety concerns the mechanical loads placed upon the tibia and the support plate.

The interventions will all be made on computer models, the 3D imaging data will be used to create the intact (un-operated) models of the subject tibias. Each model will then be virtually operated upon, with both the ToKa and Tomofix procedures. The models will then be loaded with physiological loads experienced during function and the mechanical states compared.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

This is a virtual clinical trial, virtual cohort generated from anonymised imaging data from patients with osteoarthritis of the knee

Masking: None (Open Label)
Masking Description:

This virtual trial allows all participants to receive both treatments, i.e. HTO using existing generic technique and HTO using novel subject specific technique

Primary Purpose: Treatment

• Condition: Osteoarthritis, Knee

Intervention

• Procedure: Opening wedge high tibial osteotomy
  Realignment of knee by creating an opening wedge osteotomy in the upper part of the tibia
  Other Name: HTO
• Device: ToKa subject specific custom HTO plate
  Subject specific custom plate for stabilizing an open wedge HTO
  Other Name: ToKa plate
• Device: Generic HTO plate
  Generic plate for stabilizing an open wedge HTO
  Other Name: Generic plate

Study Arms

• Experimental: ToKa HTO

  Opening wedge high tibial osteotomy

  ToKa subject specific custom HTO plate

  Interventions:

  • Procedure: Opening wedge high tibial osteotomy
  • Device: ToKa subject specific custom HTO plate
• Active Comparator: Generic HTO

  Opening wedge high tibial osteotomy

  Generic HTO plate

  Interventions:

  • Procedure: Opening wedge high tibial osteotomy
  • Device: Generic HTO plate

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 26, 2018): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 1, 2018
• Estimated Primary Completion Date: June 1, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Appropriate existing CT data of lower limb.
• Male or Female, aged 18 years or above.
• Diagnosed with moderate to severe OA of the knee.

Exclusion Criteria:

• Abnormal anatomy of tibia or presence of pathology other than OA, e.g. bone tumour.
• Previous knee or osteotomy surgery.
• Presence of metal-work

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT03419598
• Other Study ID Numbers: RG433_TVT003
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided
• Plan Description: Virtual cohort may be re-used for further studies, all virtual patients are anonymized

• Responsible Party: Richie Gill, University of Bath
• Study Sponsor: University of Bath
• Collaborators: Royal Devon and Exeter NHS Foundation Trust

Investigators

• Principal Investigator: Richie Gill, DPhil; University of Bath
• Principal Investigator: Andrew Toms, MD; Royal Devon & Exeter NHS Trust

• PRS Account: University of Bath
• Verification Date: January 2018