TRabecular Metal Economic and Clinical Knee Trial

Study Overview
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Brief Summary
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To compare the differences, if any, in clinical outcome, patient satisfaction and survivorship between cemented and uncemented Total Knee Replacements (TKR)? To investigate if there are health economic implications of using uncemented TKRs in the NHS?

Detailed Description
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The investigators propose to undertake a randomised controlled trial comparing Trabecular metal uncemented TKR with cemented TKR. The primary aim will be to determine whether there is a clinically significant difference in outcome between cemented and uncemented knee prosthesis over a 10-year period. The investigators will assess the patient's functional ability using two clinical knee scores the New Knee Society Score (NKSS) and Oxford knee score (OKS). In addition to employing these two standard clinical scores, the investigators will also utilise the Forgotten Joint Score (FJS). The FJS differentiates patients' awareness of the participant's artificial joint which is an important concept in knee arthroplasty. In contrast to hip arthroplasty where the majority of patients are unaware of their joint after surgery, knee arthroplasty patients rarely 'forget' that their joint is artificial. Given the difference in physical properties of trabecular metal and standard implants, the FJS scoring system may highlight potential differences that are important to patients and linked to patient satisfaction. Non-subjective assessment will be performed using Inertial Measuring Units (IMU), which measure the relative position of limbs in space and is a useful measure for clinical movement analysis. Participants will be asked to perform daily task such as walking, standing from a chair and walking up and down stairs, wearing the IMU, before and after surgery. This allows us to see functional improvements after surgery and if there are functional differences between the cemented and uncemented implant. Clinical evaluation and radiological assessment will be carried out over a 10-year period recording complications and clinical performance of patients and implants. In addition to carrying out a clinical evaluation of the trabecular metal uncemented knee and cemented knee systems, the investigators will also undertake a health economic assessment of the benefits of using uncemented trabecular metal prostheses. The most expensive resources in a hospital theatre environment are the surgeon and anaesthetist and maximising their utilisation is essential. The removal of cement mixing and curing time from a TKR offers a potential time saving during the operation. However, the time saved using an uncemented prosthesis during a single operation is unlikely, in isolation, to be sufficient to allow additional clinical activity to be carried out. Nevertheless, by combining multiple uncemented knee replacement operations in a single theatre session it may be possible to save sufficient time during the entire day to facilitate an additional surgical procedure, thus increasing the utilisation of surgeons, anaesthetists and theatre staff. If this were achievable, it would add significant value for health care providers. Despite the success of knee arthroplasty 18% of patients are dissatisfied with their outcome [16]. These are an important group of patients and understanding better the issues that these patients encounter is key in achieving better satisfaction rates and ensuring appropriate use of Orthopaedic implants. The investigators will therefore also study patient factors such as depression and ability to deal with pain/discomfort and correlate these with post-surgical outcome. Trabecular metal uncemented implants potentially offer benefits to both patient and surgeon but as yet there is insufficient data available to support widespread use of this product. It is the investigators belief that uncemented knees are underutilised by surgeons because there are a number of areas of concern which have not been adequately addressed in clinical studies. The investigators hope to address these concerns in this study.

Official Title
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Health Economic and Clinical Comparison of Trabecular Metal Uncemented and Cemented Modular Total Knee Replacements - A Double Blinded Randomised Controlled Trial

Conditions
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Total Knee Replacement, Orthopedics

Intervention / Treatment
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* Device: Persona (Zimmer) posterior stabilised uncemented Trabecular Metal™ (Tibia and Femur) prosthesis
* Device: Persona (Zimmer) posterior stabilised cemented Trabecular Metal™ (Tibia and Femur) prosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects may be recruited to the evaluation. Age - there are no restrictions relating to age of the patient. Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained. Subjects who in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigation procedures and are willing to return to the hospital for all the required post-operative follow-ups. Subjects with uni-lateral osteoarthritis of the knee or subjects with bi-lateral osteoarthritis of the knee, who have a well functioning and pain free knee replacement in the contralateral knee. Subjects who require a TKR for surgical management of osteoarthritis Exclusion Criteria: Patients who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in the study. Patients with bi-lateral disease that significantly impacts on their current function and pain. Patients who require revision knee arthroplasty surgery. Disorders of the feet, ankles, hips or spine causing significant abnormal gait or significant pain. Neurological conditions affecting movement. Patients with a pathology, which, in the opinion of the Chief Investigator, will adversely affect healing. Patients with other disorders which, in the opinion of the Chief Investigator, will/could impair rehabilitation. Subjects who in the opinion of the study investigator are unlikely to comply with the study follow-up protocol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A Double Blinded Randomised Controlled Trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cemented knee replacement<br>total knee replacement with cemented modular knee replacement as per current standard for total knee replacements. | Device: Persona (Zimmer) posterior stabilised cemented Trabecular Metal™ (Tibia and Femur) prosthesis<br>* Persona (Zimmer) posterior stabilised uncemented Trabecular Metal™ (Tibia and Femur) prosthesis vs a Persona (Zimmer) posterior stabilised cemented prosthesis<br>|
| Experimental: Uncemented knee replacement<br>total knee replacement with uncemented modular knee replacement, which is CE certified and accepted in the field. | Device: Persona (Zimmer) posterior stabilised uncemented Trabecular Metal™ (Tibia and Femur) prosthesis<br>* Persona (Zimmer) posterior stabilised uncemented Trabecular Metal™ (Tibia and Femur) prosthesis vs a Persona (Zimmer) posterior stabilised cemented prosthesis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Oxford Knee Score (Patient reported outcome measure of pain and function) | Oxford Knee Score is a joint specific 12 question questionnaire related to the pain and function participants believe they are experiencing in their affected knee. A score of 0 indicating high pain and poor function, while a score of 48 is a healthy highly functioning knee joint. Oxford Knee Score will be recorded pre-operatively, at 3 months and 1 year post-operatively. The difference measured at 1 year will be the primary outcome. The questionnaire will be completed either, face-to-face, via postal questionnaires or via virtual appointments. | Baseline, 3 months, 1, 2, 5 and 10 years post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in costs per quality adjusted life year (QALY) per participant. | Measured using a breadth of health economic data collected during the course of the study, including, cost of surgery, surgical time, implant costs, other related surgical costs (consumables etc), recovery time, rehabilitation costs, readmissions, revisions surgeries and GP visits in conjunction with quality of life data. This will provide a cost per quality of adjusted life year per participant. | 1, 2 and 10 years post-operatively | 
| Change in operation time (minutes) | Measured using video recordings for surgical procedures. Data will be collected from recordings to conduct motion and time analysis to provide an accurate operation time. | After last intervention is administered | 
| Change in clinical movement: walking | Participants will be given an inertial measurement unit which is an electronic device that records movement during an activity. | Baseline, 3 months, 1, 2 years post-operatively | 
| Change in clinical movement: standing from sitting | Participants will be given an inertial measurement unit which is an electronic device that records movement during an activity. | Baseline, 3 months, 1, 2 years post-operatively | 
| Change in clinical movement: walking down stairs | Participants will be given an inertial measurement unit which is an electronic device that records movement during an activity. | Baseline, 3 months, 1, 2 years post-operatively | 
| Change in New Knee Society Score (Patient reported outcome measure of pain and function) | New Knee Society Score is a validated questionnaire related to the knee pain and function. The questionnaire will be completed either, face-to-face, via postal questionnaires or via virtual appointments. | Baseline, 3 months, 1, 2 years' post-operatively | 
| Change in Forgotten Joint Score (Patient reported outcome measure of their awareness of their artificial knee) | Forgotten Joint Score is a validated questionnaire related to the awareness a patients experiences regarding their artificial joint. The questionnaire will be completed either, face-to-face, via postal questionnaires or via virtual appointments. | 3 months, 1, 2, 5 and 10 years post-operatively | 
| Change in Patient Satisfaction (Patient reported outcome measure of post-operative satisfaction of the intervention) | Patient satisfaction will be reported using a questionnaire asking Overall, how satisfied are you with the outcome of your surgery? on a scale of Very satisfied, satisfied, unsure, dissatisfied and very dissatisfied, and reporting If you could go back in time, would still chose to have this operation? as either Yes or No. | 3 months, 1, 2, 5 and 10 years post-operatively | 
| Change in Hospital Anxiety and Depression Score (Patient reported outcome measure of depression and anxiety surrounding hospitalisation) | Hospital Anxiety and Depression Score is a validated 14 point questionnaire related to the a patients anxiety (7 questions) or depression (7 questions) related to hospitalisation. The questionnaire will be completed either, face-to-face, via postal questionnaires or via virtual appointments. | Baseline, and 1, 2 years' post-operatively | 
| Change in Short Form-12 (Patient reported outcome measure of general quality of life) | Short form-12 is a validated questionnaire that measures a participants general quality of life. The questionnaire will be completed either, face-to-face, via postal questionnaires or via virtual appointments. | Baseline and 1, 2 years post-operatively | 
| Change in Pain Catastrophising Scale (Patient reported outcome measure of patients perceptions of pain) | Pain Catastrophising Scale is a validated questionnaire that reports a patients perception of pain. The questionnaire will be completed either, face-to-face, via postal questionnaires or via virtual appointments. | Baseline and 1, 2 years' post-operatively | 
| Change in EuroQoL-5 Dimensions (EQ-5D) (Patient reported outcome measure of a patients perceptions of their overall health) | EQ-5D is a validated questionnaire that measures an individual's perception of their overall health. The questionnaire will be completed either, face-to-face, via postal questionnaires or via virtual appointments. | Baseline, 3 months, 1, 2, 5 and 10 years post-operatively | 
| Change in Pain Visual Analogue Scale (Patient reported outcome measure of joint pain) | Pain Visual Analogue Scale is measured on a 100mm scale; 0mm indicating no pain and 100mm indicating worst imaginable pain. The questionnaire will be completed either, face-to-face, via postal questionnaires or via virtual appointments. | Baseline, 3 months, 1, 2, 5 and 10 years post-operatively | 
| Change in Stiffness Visual Analogue Scale (Patient reported outcome measure of joint stiffness) | Stiffness Visual Analogue Scale is measured on a 100mm scale; 0mm indicating no pain and 100mm indicating worst imaginable pain. The questionnaire will be completed either, face-to-face, via postal questionnaires or via virtual appointments. | Baseline, 3 months, 1, 2, 5 and 10 years post-operatively | 
| Change in Range of Motion (Measure of joint stiffness) | Range of Motion in the knee is measured using a goniometer. The assessment will be done at a face-to-face appointment by a research nurse. | Baseline, 3 months, and 1, 2 years post-operatively | 
| Change in Post-Op Patient Recovery Diary (Patient Reported outcome measure of pain, stiffness and movement in the immediate post-op period.) | Post-Operative Patient Recovery Diaries are completed on daily basis following surgery until 14 days post-operative and subsequently weekly until 6 weeks post-operative. Pain and Stiffness Visual Analogue Scales are measured on a 100mm scale. Patient satisfaction will be reported using a questionnaire asking Currently how satisfied are you with the pain level of your knee while sitting? and Currently how satisfied are you with the pain level of your knee while performing light household duties? on a scale of Very Satisfied/Satisfied/Unsure/Dissatisfied/Very dissatisfied. Patient recovery is measured by asking patients Yes/No whether they can walked at distance, stand, or walk up and down stairs. In addition, patients are asked for how long they had walked that day before stopping due to pain and on increasing scale of time from 0-5 minutes to >1 hour. Diaries are completed by patients at home. | 0 to 6 weeks post-operatively | 
| Change in Canadian Occupational Performance Measure (Patient reported outcome measure of self-perception and performance in everyday living) | Canadian Occupational Performance Measure is a validated questionnaire which reports on a participants self-perception and performance in everyday living. The questionnaire will be completed either, face-to-face, via postal questionnaires or via virtual appointments. | Baseline and 1, 2, years' post-operatively | 
| Change in PainDETECT Score (Patient reported outcome measure of patients perceptions of pain) | PainDETECT Score is a validated questionnaire that reports a patients perception of pain. The questionnaire will be completed either, face-to-face, via postal questionnaires or via virtual appointments. | Baseline and 1, 2 years' post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uncemented, Total Knee Replacements, Orthopedics, Orthopedic devices, Arthroplasty