Post-marketing Surveillance Study of the Triathlon Tritanium Baseplate

July 17, 2019 updated by: Golden Jubilee National Hospital

Five Year Survival and Functional Assessment of the Triathlon Cementless Total Knee System Using the Tritanium Tibial Baseplate

The aim of the study is to assess the performance of the cementless Triathlon Tritanium tibial baseplate for total knee replacement, with a minimum follow up of 5 years.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

All potential total knee arthroplasty patients from two consultant orthopaedic surgeons at the Golden Jubilee National Hospital (GJNH) will be screened in relation to the inclusion/exclusion criteria. Invitation letters and participant information sheets (PIS) will be sent out to suitable patients who have been referred to the GJNH for total knee replacement (allocated patients) prior to their pre-operative consultation with their surgeon. They will be approached at their consultation visit to seek consent to take part in the study. Patients who have been referred to the GJNH for assessment for a knee replacement (see and treat patients) will be approached only if they are deemed eligible for knee replacement by their consultant, and will be given a copy of the participant information sheet along with the invitation letter. They will be approached for consent to take part in the study at their pre-operative assessment. All patients will be given the opportunity to ask questions about the study before signing the consent form. Consent will be taken by the chief investigator or their delegate, using a signed form.

One hundred patients will be recruited to the study. They will have their surgery performed by one of the participating consultants using the study implant, the Triathlon Tritanium cementless tibial baseplate manufactured by Stryker Corporation.

Participants will receive their standard in-patient care and rehabilitation. Standard hospital care for knee arthroplasty patients is for them to return to the hospital for a post-operative review at 6 weeks and then 1 year and 7 years after operation. Study participants will also be asked to attend the GJNH for two additional research specific appointments at six months and five years. They will be also contacted by post or via telephone to complete a study questionnaire (patient satisfaction) at 3 years post operation.

During the standard care appointments, patients will be reviewed by a member of the arthroplasty team who will collect routine data on the clinical and functional outcomes and implant stability. These data include the Oxford Knee Score (OKS), EURO Quality of life questionnaire (EQ-5D 5L), patient satisfaction and standard radiographic assessment of the implant.

Detailed radiographic analysis will be carried out on radiographs collected as standard and specifically for the study. These will be post-operation at day one (standard), 6 weeks (standard), 6 months (study), 1 year (standard) and the 5 years (study) time points. Study specific radiographic assessment will consist of assessment for radiolucency and osteolysis at specific regions around the tibial and femoral components. Pre-operatively, a standard weight bearing long- leg anterior-posterior (AP) view, lateral view and a skyline view is obtained as per standard care. Post-operatively, standard care consists of a standard weight bearing long-leg AP radiograph at 6 weeks and a short AP and Lateral view at all other reviews.

Study participants will also have two sessions of specialised functional assessment (biomechanical movement analysis and 6-minute walk test) before operation and 1 year after operation during their standard pre and postoperative visits. Biomechanical movement analysis will be carried out in an on-site movement analysis laboratory. Study participants will be required to wear suitable clothing (e.g. tee shirt and shorts) and be barefoot. A number of reflective markers will be attached to specific locations on the body using suitable double sided tape which can be tracked by a number of infrared cameras. participants will be asked to perform the following tasks; walking, stepping up, stepping down, sit-to-stand, stand-to-sit and single leg balance. Each task will be performed at least three times to enable the collection of three good sets of data. In addition, the two stepping tasks will be repeated for each limb. The single leg balance will be performed once for each leg and data will be collected for 30 seconds per limb. A motion capture system will collect limb and torso movements during the task performances while force plates will collect ground reaction forces. The 6-minute walk test requires the participant to walk around a course during a six minute period. They are allowed to have rest breaks for as long and as often as they require. They will be asked to stop walking six minutes after the start of the test and the distance covered during the period will be noted.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Dunbartonshire
      • Clydebank, West Dunbartonshire, United Kingdom, G81 4dy
        • Golden Jubilee National Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who have been referred to the Golden Jubilee National Hospital for total knee replacement.

Description

Inclusion Criteria:

  1. Unilateral TKA
  2. Age 18-75 years
  3. BMI <40
  4. From one of the following health boards: Ayrshire & Arran, Forth Valley, Greater Glasgow & Clyde, Highland, Lanarkshire or Lothian
  5. Suitable to receive the study implant

Exclusion Criteria:

  1. Revision of existing knee replacement
  2. Previous hip or knee replacement surgery if within the last 12 months
  3. Previous ankle surgery
  4. Diagnosed osteopenia or osteoporosis
  5. Proximal tibial bone defects
  6. Unable to give informed consent
  7. Unwilling to take part
  8. Unable to return to the Golden Jubilee National Hospital for followup appointments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Arthroplasty cohort
A cohort of patients who will undergo knee replacement surgery and will receive Triathlon Tritanium (cementless) tibial implant.
Procedure: Knee Replacement
Surgical replacement of arthritic knee with an implant
Other Names:
  • Knee Arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant survival at five years
Time Frame: 5 years
Kaplan-Meier implant survival at 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Component loosening rate
Time Frame: 5 years
Number of loose components reported
5 years
Fracture rate
Time Frame: 5 years
Number of peri-prosthetic fractures reported
5 years
Infection rate
Time Frame: 5 years
Number of infections reported
5 years
Radiolucency
Time Frame: review at 6 weeks, 6 months, 1 and 5 years
Degree of radiolucent lines around the components
review at 6 weeks, 6 months, 1 and 5 years
Bone quality
Time Frame: review at 6 weeks, 6 months, 1 and 5 years
Evidence of bony ingrowth or osteolysis
review at 6 weeks, 6 months, 1 and 5 years
Component migration
Time Frame: review at 6 weeks, 6 months, 1 and 5 years
Component movement in mm or degrees from the one day post-operative position
review at 6 weeks, 6 months, 1 and 5 years
Oxford Knee Score
Time Frame: 6 weeks, 6 months, 1, 3 and 5 years
Patient-reported knee pain and function
6 weeks, 6 months, 1, 3 and 5 years
EQ5D-5L
Time Frame: 6 weeks, 6 months, 1, 3 and 5 years
Patient-reported quality of life
6 weeks, 6 months, 1, 3 and 5 years
Patient satisfaction
Time Frame: 6 weeks, 6 months, 1, 3, and 5 years
Patient-reported satisfaction of the knee using a five point Likert scale
6 weeks, 6 months, 1, 3, and 5 years
Knee function during walking
Time Frame: 1 year
Knee angles of movement and loads collected using clinical movement analysis
1 year
Knee function during stepping up
Time Frame: 1 year
Knee angles of movement and loads collected using clinical movement analysis
1 year
Knee function during stepping down
Time Frame: 1 year
Knee angles of movement and loads collected using clinical movement analysis
1 year
Knee function during sit-to-stand
Time Frame: 1 year
Knee angles of movement and loads collected using clinical movement analysis
1 year
Knee function during stand-sit-to
Time Frame: 1 year
Knee angles of movement and loads collected using clinical movement analysis
1 year
Knee stability during single leg balance
Time Frame: 1 year
Body sway collected using clinical movement analysis in mm
1 year
6 minute walk test
Time Frame: 1 year
Aerobic endurance assessed by the distance walked (m) in a six minutes
1 year
Revision rate
Time Frame: 5 years
Number of cases revised for any reason or for infection
5 years
Surgeon feedback
Time Frame: 1 day post-operatively
Surgeon assessment of the implant ease of implantation using a questionnaire
1 day post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Golden Jubilee National Hospital

Collaborators

Stryker GI Ltd.

Investigators

  • Principal Investigator: Nicholas Ohly, MBBS, FRCSEd, nick.ohly@gjnh.scot.nhs.uk

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2018

Primary Completion (Anticipated)

August 1, 2024

Study Completion (Anticipated)

August 1, 2024

Study Registration Dates

First Submitted

September 14, 2016

First Submitted That Met QC Criteria

September 14, 2016

First Posted (Estimate)

September 19, 2016

Study Record Updates

Last Update Posted (Actual)

July 18, 2019

Last Update Submitted That Met QC Criteria

July 17, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ortho 16-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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