Visionaire Health Economics Study Comparing Economic Outcomes Between Visionaire and Standard Instrumentation

NCT02158819 | Completed DMC

• 1 other identifier: VISHE.13
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose and primary objective of this study is to compare health economic outcomes between the use of a patient-matched cutting guide (Visionaire) versus the use of standard instrumentation in Total Knee Arthroplasty(TKA). Data will be collected pre-operatively, intra-operatively and post operatively up until and including the six week post-operative assessment. The secondary objectives of the study are to compare safety and early readmission rates between the two techniques. The study hypothesis is that there is no difference in the cost of the episode of care from hospital admission to discharge, including pre-operative radiology costs and cost of resources, with the Visonaire patient-matched cutting guide compared to standard instrumentation.

Conditions

Osteoarthritis, Knee

Keywords

Visionaire; Health Economics; Degenerative arthritis; total knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• Cost of the episode of care from admission to hospital to discharge

  The cost of the episode of care from admission to hospital to discharge , including pre-operative radiology costs and costs associated with Visionaire and will incorporate the costs of time, number of instruments utilised, blood transfusion requirements, length of stay and pre-operative xray and MRI costs.

  up to 1 week

Secondary Outcomes (1)

• Percentage of patients that experience short term complications and/or early readmissions

  up to 6 weeks

Study Arms (2)

TKA with standard instrumentation

NO INTERVENTION

This arm consists of the Genesis II Total knee implant system or the Legion Primary total knee system with standard instrumentation

Total knee arthroplasty with Visionaire

ACTIVE COMPARATOR

This arm will consist of the Genesis II Total Knee Implant System or Legion Primary Total Knee System with the Visionaire patient-matched instrumentation

Device: Total knee arthroplasty with Visionaire

Interventions

Total knee arthroplasty with Visionaire DEVICE

Patient Specific Instrumentation

Total knee arthroplasty with Visionaire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Degenerative arthritis of the knee requiring unilateral primary Total Knee Arthroplasty in subjects for whom the use of patient-matched cutting guides or standard instrumentation are, in the surgeon's opinion, clinically appropriate and acceptable forms of treatment;
• Patient is of legal age to consent and is skeletally mature;
• The patient is able to fully understand the purpose of the trial, and his/her role as a participant in the study

You may not qualify if:

• Patient is known to have poor bone stock making a Total Knee Arthroplasty unjustifiable.
• Patient is immuno-suppressed.
• Patient has physical, emotional or neurological conditions that would compromise the subject's compliance with postoperative rehabilitation and follow-up.
• Patient is pregnant or may become pregnant during the course of the study, or is lactating.
• Patient has a history of prior ipsilateral major knee surgery (e.g. arthroplasty, high tibial osteotomy, or tibial plateau fracture). Minor prior procedures such as Anterior Cruciate Ligament repair, meniscectomy, or arthroscopy are not excluded.
• Patient has active, localized or systemic infection.
• Patient is severely overweight (BMI \>40).
• Patient is a prisoner.
• Patient has had a total joint arthroplasty of the contralateral limb in the last 12 months.
• Patient presently identified with future need for bilateral TKA within the next twenty-four months.
• Patient has a known or suspected hypersensitivity/allergy to foreign materials contained in the implant

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (5)

Life Bay View Hospital

Mossel Bay, Cape Town, 6506, South Africa

Location

Sunninghill Hospital

Johannesburg, Gauteng, South Africa

Location

Pretoria East Hospital

Pretoria, Gauteng, South Africa

Location

Private Practice

Durban, KwaZulu-Natal, 4001, South Africa

Location

Life Claremont Hospital

Cape Town, Western Cape, South Africa

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Andrew Baker

  Private Practice

  PRINCIPAL INVESTIGATOR

• Lieth Stewart

  Life Claremont Hospital

  PRINCIPAL INVESTIGATOR

• Willem Tollig

  Pretoria East Hospital

  PRINCIPAL INVESTIGATOR

• Michael Barrow

  Sunninghill Hospital

  PRINCIPAL INVESTIGATOR

• Dan Potgieter

  Life Bay View Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2014
• First Posted: June 9, 2014
• Study Start: July 9, 2014
• Primary Completion: May 15, 2017
• Study Completion: May 15, 2017
• Last Updated: January 8, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (5)