Advertisement

Topics

A Post Marketing Surveillance Study of the Triathlon Knee System

2016-09-19 20:08:24 | BioPortfolio

Summary

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.

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 as per their standard practice for the target study patient. This involves using 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 (study) and the 5 years (standard) 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 and the single leg balance will be repeated for each 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Arthritis

Intervention

Knee Replacement

Status

Not yet recruiting

Source

Golden Jubilee National Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-09-19T20:08:24-0400

Clinical Trials [2833 Associated Clinical Trials listed on BioPortfolio]

Navio Robotic Versus Conventional Total Knee Arthroplasty

Total knee replacement surgery is a conventional approach to alleviating the pain and lack of function resulting from arthritis of the knee. While conventional knee replacement surgery is ...

The Assessment of Patient Specific Instrumentation for Unicompartmental Knee Replacement

Patient-specific instrumentation guides have previously been used to improving surgical accuracy and ease of implantation during Total Knee Replacement but have received less attention for...

A Multicenter Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System Versus Off-the-Shelf Replacement

Patients will be randomized to either ConforMIS iTotal Knee Replacement or Off the Shelf knee replacement. The patient will conduct functional testing and answer questionnaires. Th...

ROCC Knee Data Collection

This observational study intends to collect efficacy and safety data on ROCC Knee system.

Total Knee Replacement With the Attune vs. the Press Fit Condylar (PFC) Sigma.

100 knees with primary osteoarthritis and scheduled for a total knee replacement (TKR) will be recruited from our waiting list. The patients will be randomized to become operated with the ...

PubMed Articles [3665 Associated PubMed Articles listed on BioPortfolio]

A Physical Therapist-Administered Physical Activity Intervention After Total Knee Replacement: Protocol for a Randomized Controlled Trial.

The definitive treatment for knee osteoarthritis is a total knee replacement, which results in a clinically meaningful improvement in pain and physical function. However, evidence suggests that physic...

Thromboembolic diseases and the use of vena cava filters.

Mr GW is a 77-year-old gentleman who is hoping to have a total knee replacement of his left knee. He underwent a knee replacement on the right in 2011 under spinal anaesthetic, where his postoperative...

Low Prevalence of Hip and Knee Arthritis in Active Marathon Runners.

Existing evidence on whether marathon running contributes to hip and knee arthritis is inconclusive. Our aim was to describe hip and knee health in active marathon runners, including the prevalence of...

Preoperative Care of the TKA Patient.

Total knee arthroplasty continues to increase in popularity and remains the most common joint replacement surgery. The success of total knee replacement surgery is attributed to improved outcomes, a b...

Bilateral total knee replacement.

Bilateral osteoarthrosis of the knee is very frequent and disabling; the treatment in severe cases is joint replacement. Bilateral condition and severe knee pain are common and the definitive treatmen...

Medical and Biotech [MESH] Definitions

Replacement of the knee joint.

Replacement for a knee joint.

Arthritis in children, with onset before 16 years of age. The terms juvenile rheumatoid arthritis (JRA) and juvenile idiopathic arthritis (JIA) refer to classification systems for chronic arthritis in children. Only one subtype of juvenile arthritis (polyarticular-onset, rheumatoid factor-positive) clinically resembles adult rheumatoid arthritis and is considered its childhood equivalent.

An instrument used to assess the results of rehabilitation from knee injuries, especially those requiring ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION. It measures recovery of knee joint function based on ACTIVITIES OF DAILY LIVING.

Injuries to the knee or the knee joint.

More From BioPortfolio on "A Post Marketing Surveillance Study of the Triathlon Knee System"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Joint Disorders
A joint is where two or more bones come together, like the knee, hip, elbow, or shoulder. Joints can be damaged by many types of injuries or diseases, including Arthritis - inflammation of a joint causes pain, stiffness, and swelling with ...

Orthopedics
Arthroplasty Joint Disorders Orthopedics Spinal Cord Disorders Orthopedics is the science or practice of correcting deformities caused by disease or damage to the bones and joints of the skeleton. This specialized branch of surgery may ...


Searches Linking to this Trial