TRabecular Metal Economic and Clinical Knee Trial (TRECK)

May 11, 2022 updated by: NHS Greater Glasgow and Clyde

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

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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

144

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Scotland
      • Glasgow, Scotland, United Kingdom, G31 2ER
        • Recruiting
        • Dept of Orthopaedics, Glasgow Royal Infirmary
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Bryn Jones, Mr
        • Sub-Investigator:
          • Angus MacLean, Mr
        • Sub-Investigator:
          • Andrew Shaw, Mr
        • Sub-Investigator:
          • Colin Drury, Mr
        • Principal Investigator:
          • Mark Blyth, Mr

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Cemented knee replacement
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
Persona (Zimmer) posterior stabilised uncemented Trabecular Metal™ (Tibia and Femur) prosthesis vs a Persona (Zimmer) posterior stabilised cemented prosthesis
EXPERIMENTAL: Uncemented knee replacement
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
Persona (Zimmer) posterior stabilised uncemented Trabecular Metal™ (Tibia and Femur) prosthesis vs a Persona (Zimmer) posterior stabilised cemented prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Oxford Knee Score (Patient reported outcome measure of pain and function)
Time Frame: Baseline, 3 months, 1, 2, 5 and 10 years post-operatively
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.
Time Frame: 1, 2 and 10 years post-operatively
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)
Time Frame: After last intervention is administered
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
Time Frame: Baseline, 3 months, 1, 2 years post-operatively
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
Time Frame: Baseline, 3 months, 1, 2 years post-operatively
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
Time Frame: Baseline, 3 months, 1, 2 years post-operatively
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)
Time Frame: Baseline, 3 months, 1, 2 years' post-operatively
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)
Time Frame: 3 months, 1, 2, 5 and 10 years post-operatively
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)
Time Frame: 3 months, 1, 2, 5 and 10 years post-operatively
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)
Time Frame: Baseline, and 1, 2 years' post-operatively
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)
Time Frame: Baseline and 1, 2 years post-operatively
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)
Time Frame: Baseline and 1, 2 years' post-operatively
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)
Time Frame: Baseline, 3 months, 1, 2, 5 and 10 years post-operatively
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)
Time Frame: Baseline, 3 months, 1, 2, 5 and 10 years post-operatively
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)
Time Frame: Baseline, 3 months, 1, 2, 5 and 10 years post-operatively
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)
Time Frame: Baseline, 3 months, and 1, 2 years post-operatively
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.)
Time Frame: 0 to 6 weeks post-operatively
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)
Time Frame: Baseline and 1, 2, years' post-operatively
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)
Time Frame: Baseline and 1, 2 years' post-operatively
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

Collaborators and Investigators

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

Sponsor

NHS Greater Glasgow and Clyde

Collaborators

Zimmer Biomet
University of Strathclyde

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

Helpful Links

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)

May 10, 2022

Primary Completion (ANTICIPATED)

May 30, 2024

Study Completion (ANTICIPATED)

May 1, 2034

Study Registration Dates

First Submitted

April 4, 2019

First Submitted That Met QC Criteria

December 16, 2020

First Posted (ACTUAL)

December 21, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 17, 2022

Last Update Submitted That Met QC Criteria

May 11, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GN13OR267

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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