Total Knee ReplacementTRECKNCT04677907
TRabecular Metal Economic and Clinical Knee Trial
A study testing Persona (Zimmer) posterior stabilised uncemented Trabecular Metal™ (Tibia and Femur) prosthesis and Persona (Zimmer) posterior stabilised cemented Trabecular Metal™ (Tibia and Femur) prosthesis in people with Total Knee Replacement and Orthopedics, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
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? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Replacement, Orthopedics
- What is being tested?
- Persona (Zimmer) posterior stabilised uncemented Trabecular Metal™ (Tibia and Femur) prosthesis and Persona (Zimmer) posterior stabilised cemented Trabecular Metal™ (Tibia and Femur) prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 May 2022to 30 Jun 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
James Doonan, Dr contact
United Kingdom1 site, 1 recruiting
- Recruiting
Dept of Orthopaedics, Glasgow Royal Infirmary
Glasgow, Scotland, G31 2ER
Mark JG Blyth, Mr, mark.blyth@ggc.scot.nhs.uk
James Doonan, PhD, james.doonan@glasgow.ac.uk
About this study
Official title: 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?
Read the 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.
- Conditions
- Total Knee Replacement, Orthopedics
- Being tested
- Persona (Zimmer) posterior stabilised uncemented Trabecular Metal™ (Tibia and Femur) prosthesis, Persona (Zimmer) posterior stabilised cemented Trabecular Metal™ (Tibia and Femur) prosthesis
- Keywords
- Total Knee Replacements, Orthopedics, Orthopedic devices, Arthroplasty, Uncemented
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Persona (Zimmer) posterior stabilised uncemented Trabecular Metal™ (Tibia and Femur) prosthesisDevice
Persona (Zimmer) posterior stabilised uncemented Trabecular Metal™ (Tibia and Femur) prosthesis vs a Persona (Zimmer) posterior stabilised cemented prosthesis
Persona (Zimmer) posterior stabilised cemented Trabecular Metal™ (Tibia and Femur) prosthesisDevice
Persona (Zimmer) posterior stabilised uncemented Trabecular Metal™ (Tibia and Femur) prosthesis vs a Persona (Zimmer) posterior stabilised cemented prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Cemented knee replacement | Active comparator | total knee replacement with cemented modular knee replacement as per current standard for total knee replacements. Receives: Device: Persona (Zimmer) posterior stabilised cemented Trabecular Metal™ (Tibia and Femur) prosthesis |
| Uncemented knee replacement | Experimental | total knee replacement with uncemented modular knee replacement, which is CE certified and accepted in the field. Receives: Device: Persona (Zimmer) posterior stabilised uncemented Trabecular Metal™ (Tibia and Femur) prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, 1, 2, 5 and 10 years post-operatively
Secondary outcomes (18)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 1, 2 years' post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start10 May 2022
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Jun 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Double Blinded Randomised Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet, University of Strathclyde
- Responsible party
- Sponsor
- Investigators
- Mark JG Blyth, Mr, Principal investigator, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677907
- Sponsor's protocol ID
- GN13OR267
- Acronym
- TRECK
- Status last verified
- Jun 2025
- First submitted
- 4 Apr 2019
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cohen R. A porous tantalum trabecular metal: basic science. Am J Orthop (Belle Mead NJ). 2002 Apr;31(4):216-7.
PubMed 12008853Hacking SA, Bobyn JD, Toh K, Tanzer M, Krygier JJ. Fibrous tissue ingrowth and attachment to porous tantalum. J Biomed Mater Res. 2000 Dec 15;52(4):631-8. doi: 10.1002/1097-4636(20001215)52:43.0.co;2-6.
PubMed 11033545Bobyn JD, Stackpool GJ, Hacking SA, Tanzer M, Krygier JJ. Characteristics of bone ingrowth and interface mechanics of a new porous tantalum biomaterial. J Bone Joint Surg Br. 1999 Sep;81(5):907-14. doi: 10.1302/0301-620x.81b5.9283.
PubMed 10530861Bobyn JD, Toh KK, Hacking SA, Tanzer M, Krygier JJ. Tissue response to porous tantalum acetabular cups: a canine model. J Arthroplasty. 1999 Apr;14(3):347-54. doi: 10.1016/s0883-5403(99)90062-1.
PubMed 10220190Zardiackas LD, Parsell DE, Dillon LD, Mitchell DW, Nunnery LA, Poggie R. Structure, metallurgy, and mechanical properties of a porous tantalum foam. J Biomed Mater Res. 2001;58(2):180-7. doi: 10.1002/1097-4636(2001)58:23.0.co;2-5.
PubMed 11241337Gandhi R, Tsvetkov D, Davey JR, Mahomed NN. Survival and clinical function of cemented and uncemented prostheses in total knee replacement: a meta-analysis. J Bone Joint Surg Br. 2009 Jul;91(7):889-95. doi: 10.1302/0301-620X.91B7.21702.
PubMed 19567852Henricson A, Linder L, Nilsson KG. A trabecular metal tibial component in total knee replacement in patients younger than 60 years: a two-year radiostereophotogrammetric analysis. J Bone Joint Surg Br. 2008 Dec;90(12):1585-93. doi: 10.1302/0301-620X.90B12.20797.
PubMed 19043129European Training Program in Microseparation Techniques. Methods. 1998 Feb;14(2):235.
PubMed 9571079Nilsson KG, Karrholm J, Ekelund L, Magnusson P. Evaluation of micromotion in cemented vs uncemented knee arthroplasty in osteoarthrosis and rheumatoid arthritis. Randomized study using roentgen stereophotogrammetric analysis. J Arthroplasty. 1991 Sep;6(3):265-78. doi: 10.1016/s0883-5403(06)80174-9.
PubMed 1940933Baker PN, van der Meulen JH, Lewsey J, Gregg PJ; National Joint Registry for England and Wales. The role of pain and function in determining patient satisfaction after total knee replacement. Data from the National Joint Registry for England and Wales. J Bone Joint Surg Br. 2007 Jul;89(7):893-900. doi: 10.1302/0301-620X.89B7.19091.
PubMed 17673581
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Economic and Clinical Comparison of Trabecular Metal Uncemented and Cemented Modular Total Knee Replacements - A Double Blinded Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04677907
- Acronym / sponsor ID
- TRECK / GN13OR267
- Conditions
- Total Knee Replacement, Orthopedics
- Keywords
- Total Knee Replacements, Orthopedics, Orthopedic devices, Arthroplasty, Uncemented
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- Zimmer Biomet, University of Strathclyde
- Study start
- 10 May 2022 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Jun 2035 (estimated)
- First posted
- 21 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- A Double Blinded Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Cemented knee replacement | Active comparator | Device: Persona (Zimmer) posterior stabilised cemented Trabecular Metal™ (Tibia and Femur) prosthesistotal knee replacement with cemented modular knee replacement as per current standard for total knee replacements. |
| Uncemented knee replacement | Experimental | Device: Persona (Zimmer) posterior stabilised uncemented Trabecular Metal™ (Tibia and Femur) prosthesistotal knee replacement with uncemented modular knee replacement, which is CE certified and accepted in the field. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Persona (Zimmer) posterior stabilised uncemented Trabecular Metal™ (Tibia and Femur) prosthesisPersona (Zimmer) posterior stabilised uncemented Trabecular Metal™ (Tibia and Femur) prosthesis vs a Persona (Zimmer) posterior stabilised cemented prosthesis | Device | Uncemented knee replacement |
| Persona (Zimmer) posterior stabilised cemented Trabecular Metal™ (Tibia and Femur) prosthesisPersona (Zimmer) posterior stabilised uncemented Trabecular Metal™ (Tibia and Femur) prosthesis vs a Persona (Zimmer) posterior stabilised cemented prosthesis | Device | Cemented knee replacement |
Primary outcome
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.
18 secondary outcomes
Change in costs per quality adjusted life year (QALY) per participant.
Time frame: 1, 2 and 10 years post-operatively
Change in operation time (minutes)
Time frame: After last intervention is administered
Change in clinical movement: walking
Time frame: 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
Change in clinical movement: walking down stairs
Time frame: 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
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
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
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
Change in Short Form-12 (Patient reported outcome measure of general quality of life)
Time frame: 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
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
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
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
Change in Range of Motion (Measure of joint stiffness)
Time frame: 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
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
Change in PainDETECT Score (Patient reported outcome measure of patients perceptions of pain)
Time frame: Baseline and 1, 2 years' post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Background: PubMed 12008853Cohen R. A porous tantalum trabecular metal: basic science. Am J Orthop (Belle Mead NJ). 2002 Apr;31(4):216-7.
- Background: PubMed 11033545Hacking SA, Bobyn JD, Toh K, Tanzer M, Krygier JJ. Fibrous tissue ingrowth and attachment to porous tantalum. J Biomed Mater Res. 2000 Dec 15;52(4):631-8. doi: 10.1002/1097-4636(20001215)52:43.0.co;2-6.
- Background: PubMed 10530861Bobyn JD, Stackpool GJ, Hacking SA, Tanzer M, Krygier JJ. Characteristics of bone ingrowth and interface mechanics of a new porous tantalum biomaterial. J Bone Joint Surg Br. 1999 Sep;81(5):907-14. doi: 10.1302/0301-620x.81b5.9283.
- Background: PubMed 10220190Bobyn JD, Toh KK, Hacking SA, Tanzer M, Krygier JJ. Tissue response to porous tantalum acetabular cups: a canine model. J Arthroplasty. 1999 Apr;14(3):347-54. doi: 10.1016/s0883-5403(99)90062-1.
- Background: PubMed 11241337Zardiackas LD, Parsell DE, Dillon LD, Mitchell DW, Nunnery LA, Poggie R. Structure, metallurgy, and mechanical properties of a porous tantalum foam. J Biomed Mater Res. 2001;58(2):180-7. doi: 10.1002/1097-4636(2001)58:23.0.co;2-5.
- Background: PubMed 19567852Gandhi R, Tsvetkov D, Davey JR, Mahomed NN. Survival and clinical function of cemented and uncemented prostheses in total knee replacement: a meta-analysis. J Bone Joint Surg Br. 2009 Jul;91(7):889-95. doi: 10.1302/0301-620X.91B7.21702.
- Background: PubMed 19043129Henricson A, Linder L, Nilsson KG. A trabecular metal tibial component in total knee replacement in patients younger than 60 years: a two-year radiostereophotogrammetric analysis. J Bone Joint Surg Br. 2008 Dec;90(12):1585-93. doi: 10.1302/0301-620X.90B12.20797.
- Background: PubMed 9571079European Training Program in Microseparation Techniques. Methods. 1998 Feb;14(2):235.
- Background: PubMed 1940933Nilsson KG, Karrholm J, Ekelund L, Magnusson P. Evaluation of micromotion in cemented vs uncemented knee arthroplasty in osteoarthrosis and rheumatoid arthritis. Randomized study using roentgen stereophotogrammetric analysis. J Arthroplasty. 1991 Sep;6(3):265-78. doi: 10.1016/s0883-5403(06)80174-9.
- Background: PubMed 17673581Baker PN, van der Meulen JH, Lewsey J, Gregg PJ; National Joint Registry for England and Wales. The role of pain and function in determining patient satisfaction after total knee replacement. Data from the National Joint Registry for England and Wales. J Bone Joint Surg Br. 2007 Jul;89(7):893-900. doi: 10.1302/0301-620X.89B7.19091.
- Scottish Arthroplasty Report 2018Link provided by the sponsor.
- National Joint Registry for England and Wales Annual Report 2018.Link provided by the sponsor.
- Hip and knee arthroplasty. Australian National Joint Replacement Registry Annual Report 2018Link provided by the sponsor.
- Swedish knee arthroplasty register Annual Report 2018.Link provided by the sponsor.
- 2004 Report: Total hip and knee replacements in Canada. Canadian Joint replacement Registry (CJRR).Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James Doonan, Dr contact
Mark JG Blyth, Mr principal investigator
NHS Greater Glasgow and Clyde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Persona (Zimmer) posterior stabilised uncemented Trabecular Metal™ (Tibia and Femur) prosthesis and Persona (Zimmer) posterior stabilised cemented Trabecular Metal™ (Tibia and Femur) prosthesis in people with Total Knee Replacement and Orthopedics, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark JG Blyth, Mr (01412114107, mark.blyth@ggc.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04677907, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.