Mako Cementless TKA vs Mako Cemented TKA

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity College, London

About this trial

The overall aims of this prospective, randomised, single-blinded controlled trial are to compare functional, radiological and clinical outcomes in Mako robotic-arm assisted cementless Total Knee Arthroplasty (TKA) versus Mako robotic-arm assisted cemented TKA.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient has symptomatic knee osteoarthritis requiring primary TKA

Patient and surgeon are in agreement that TKA is the most appropriate treatment

Patient is fit for surgical intervention following review by surgeon and anaesthetist

Patient is over 18 years old at time of surgery

Disqualifiers

Patient is not suitable for routine primary TKA e.g. patient has ligament deficiency that requires a constrained prosthesis

Patient has bone loss that requires augmentation

Patient is not medically fit for surgical intervention

Patient requires revision surgery following previously failed correctional osteotomy or ipsilateral TKA

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mako cementless TKA

    Device

    Mako robotic-arm assisted total knee arthroplasty using cementless implants

  • Mako cemented TKA

    Device

    Mako robotic-arm assisted total knee arthroplasty using cemented implants

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Mako cementless TKAExperimental treatment 1 intervention
Group B: Mako cemented TKAActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The Forgotten Joint Score [FJS]

The Forgotten Joint Score (FJS) is a patient-reported outcome measure (PROM) used to assess the degree to which patients have "forgotten" their artificial joint, particularly after joint replacement surgery, like knee replacements. The score \[100 is best\] was developed to measure the success of a joint replacement by evaluating how well a patient has adjusted to the implanted joint in their daily life. It aims to show whether the patient feels like the artificial joint is part of their body and doesn't think about it in normal activities. The FJS has a series of questions about: * Pain or discomfort in the joint * Function and mobility * The awareness of the joint during daily activities (e.g., walking, climbing stairs, or sitting) * The patient's satisfaction with the joint. A high score means the patient feels that the joint replacement is functioning well and does not interfere with their quality of life, while a lower score may indicate that the patient is not fully satisfied.

Time frame
At one year post-op

Secondary outcomes

1

Assessement of tibial implant migration by maximum total point motion [MTPM] in millimetres using Radiostereometric analysis (RSA)

Radiostereometric analysis (RSA) is a highly precise imaging technique used in orthopedic research and clinical practice to track the movement of bones and implants within the body. It uses X-ray images taken from two different angles to create a 3D model of the bones or implants, which allows for highly accurate measurements of their position and motion over time. RSA is particularly useful for evaluating implant movement. It assesses the stability of orthopedic implants - for this outcome the tibial component of the knee prosthesis - to determine if it is moving, which could lead to failure. This study will assess continuous migration between the first and second year post-op, and second and fifth year post-op, measured by maximum total point motion \[MTPM\]: the maximum displacement observed between two objects (like a bone and an implant, or between two parts of an implant). Measurements are in millimetres \[mm\]; lower mm is better than higher mm, which could indicate loosening

Time frame
1, 2 and 5-years post-op
2

Assess risk of loosening of the knee prosthesis by maximum total point motion [MTPM] in millimetres using Radiostereometric analysis [RSA]

Radiostereometric analysis \[RSA\] is a highly precise and advanced imaging technique used in orthopedic research and clinical practice to track the movement of bones and implants within the body. It uses X-ray images taken from two different angles to create a 3D model of the bones or implants, which allows for highly accurate measurements of their position and motion over time. RSA is particularly useful for evaluating implant movement. It assesses the stability of orthopedic implants - for this study the knee prosthesis - to determine if it is moving or loosening, which could lead to failure. This study will assess continuous migration between the first and second year pos-op, and second and fifth year post-op, measured by maximum total point motion \[MTPM\]: the maximum displacement observed between two objects (like a bone and an implant, or between two parts of an implant). Measurements are in millimetres \[mm\]; lower mm is better than higher mm, which could indicate loosening

Time frame
1, 2 and 5-years post-op
3

Western Ontario and McMaster Universities Arthritis Index (WOMAC)

Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a widely used set of questionnaires designed to assess the severity of symptoms in patients, particularly in the knee and hip joints. For this study it is the knee joint It evaluates three main areas: Pain: How much pain the person experiences in their joints. Stiffness: How stiff the person feels in their joints. Physical Function: The difficulty the person has with everyday movements and activities. The WOMAC score is typically measured using a series of questions related to each of these areas, with responses indicating the level of severity. Each section is scored on a scale, and the total score is used to assess the degree of impact of their affect joint in their everyday life. The higher score the worse, the lower score the better outcome: 0 is the best score indicating no problems with pain, stiffness or physical function

Time frame
Preoperatively and postoperatively at 1 year, 2 years and 5 years
4

The Oxford Knee Score (OKS)

The Oxford Knee Score (OKS) is a patient completed questionnaire and assesses apatient's knee function and the severity of symptoms related to knee problems, particularly after knee surgery, such as knee replacement. The OKS consists of 12 questions related to symptoms, pain, and functional limitations. The questions focus on pain intensity, stiffness, and the ability to perform activities like walking, climbing stairs, and getting in and out of a car. Patients respond to each question on a 5-point scale, where higher scores generally indicate better knee function and less discomfort. The total score ranges from 0 to 48, with lower scores indicating more severe knee problems and higher scores indicating less pain and better function.

Time frame
Preoperatively and postoperatively at 1 year, 2 years and 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University College, London

Lead sponsor

Stryker Nordic

Collaborator