Knee OsteoarthritisNCT03618771
A Functional Comparison of Two TKR Designs
A study testing Total knee arthroplasty in people with Knee Osteoarthritis, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Total knee replacement (TKR) is an established treatment for knee osteoarthritis and leads to a satisfactory outcome in over 75% of patients. However, up to 25% of patients are not entirely satisfied with their TKR. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Total knee arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Feb 2019to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of osteoarthritis of the knee which is sufficiently symptomatic to require knee arthroplasty as assessed by their consultant orthopaedic surgeon
Who cannot join
- Inflammatory arthropathy
- Patients requiring bone augmentation
- Patients with collateral ligament incompetence
- Valgus deformity >5 degrees.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Functional Outcomes and Stability of Total Knee Replacement Design Concepts
Total knee replacement (TKR) is an established treatment for knee osteoarthritis and leads to a satisfactory outcome in over 75% of patients. However, up to 25% of patients are not entirely satisfied with their TKR. Patient dissatisfaction has been associated with inadequate functional outcome, especially during negotiation of stairs and slopes. This phenomenon, known as mid-flexion instability, is believed to be caused by excessive anterior-posterior motion of the implant during activities of daily living. This is characterised as a perception that the replaced knee is unsteady during certain tasks.
This study will compare the functional outcome of two implants that have been designed to provide patients with a functionally stable knee throughout its range of motion. The different design roles in preventing implant-related mid-flexion instability remain unknown. The functional outcome and stability of these implants will be tested non-invasively with 3D motion capture technology.
Read the detailed description
This study will compare the functional outcome of two implants that have been designed to provide patients with a functionally stable knee throughout its range of motion. The different design roles in preventing implant-related mid-flexion instability remain unknown.
The Medacta GMK-Sphere implant consists of a fully congruent medial compartment which allows freedom of movement in the lateral compartment. Both femoral and tibial components are also available in a range of 13 sizes, allowing the surgeon to find a 'best fit' for each patient. These design features are aimed to mimic the movement of a natural healthy knee, potentially preventing implant-related mid-flexion instability.
The DePuy Synthes Attune implant design aims to provide patients with optimal functional outcome. The femoral component of this implant has a gradually reducing radius, and the tibial component an S-shaped post-cam mechanism. These features are designed to facilitate smooth movement and stability during flexion.
The comparative functional outcomes and stability in gait, and other activities of daily living has not been established for the two different TKR design concepts. Functional assessments will be carried out on TKR patients pre- and post-operatively. These assessments will non-invasively quantify the knee's stability, range of motion, strength as well as walking kinematics using 3D motion capture technology. As mid-flexion instability is most notable during downhill walking, patients will be required to walk downhill on a treadmill as part of this study, to better investigate the phenomenon of mid-flexion knee instability.
This study will not involve any invasive procedure in addition to the standard of care. As such, the research burden is minimal. The main ethical issue may be that patients will not be randomised into one of the two proposed groups.
Patients will receive either the GMK-Sphere implant or the Attune implant according to their surgeon's usual practice. Surgeons who specialise in the GMK-Sphere implant will only implant the GMK-Sphere for this study, and surgeons who specialise in the Attune implant will only implant the Attune. This allows surgeons to undertake the prosthesis with which they are expert, and also limit potential surgical error in the case of surgeons having to randomise patients to different designs on the same list.
Patients will be seen by the trial team on 3 separate occasions:
- Routine pre-admission clinic: Recruitment, collection of patient information and questionnaire data and completion of pre-operative physical tests (including gait analysis with 3D motion capture technology)
- Routine post-operation clinic: Six-weeks post-operative physical tests (including gait analysis with 3D motion capture technology) and questionnaire data
- Annual post-operation clinic: 1-year post-operative physical tests (including gait analysis with 3D motion capture technology) and questionnaire data Collection of baseline data during pre-admission clinic (standard care except physical tests):
- Descriptive: Patient demographics (sex, age, height, mass, BMI), diagnosis, pattern of OA, medical co-morbidity
- Questionnaire Data
- Oxford Knee Score - A joint specific questionnaire which asks patients on the level of pain and function they believe to have in their affected knee.
- EQ5D - A questionnaire on patients' perception of their overall health. It contains a visual analogue scale where patients have to choose on a scale of 0-100 how well they believe their general health to be.
- SF12 - A general Quality of Life score. It has mental and physical components.
- Forgotten Joint Score - This asks questions not covered in the OKS on patient perception of their knee that are important to know following TKA. It focuses on other aspects of outcome other than joint pain and function.
- Expectation questionnaire - This asks what the patients expect from the surgery. The investigators use this to gauge whether patients are expecting to achieve too much or too little post-op. This is important for understanding post-operative patient satisfaction. All questionnaires ask different questions (although there is some overlap). Together, they give an overall view of the patients' perception of their general health and knee specific problems. As such, they are all deemed necessary for this investigation. There are separate scoring sheets for these subjective quantitative scores. The results are typically presented as a Mean ± SD score for each questionnaire (provided the data is normally distributed). All are valid in the English language.
- Non-invasive Physical Tests: Range of knee movement, knee muscular strength, lower limb kinematics during level (0°)- and downhill (7.5°)-walking Collection of follow-up measures by trial team between operation and post-operative visit (standard care):
- Surgical complications Collection of data during routine follow-up clinics:
6 weeks post-operation (standard care except physical tests):
- Questionnaire Data: Oxford Knee Score, SF12, EQ5D, Forgotten Joint Score
- Non-invasive Physical Tests: Range of knee movement, knee muscular strength, lower limb kinematics during level (0°)- and downhill (7.5°)-walking 12 weeks post-operation (standard care):
- Descriptive: Radiographic measurement of alignment (Non-invasive) 1 year post-operation (standard care except physical tests):
- Questionnaire Data: Oxford Knee Score, SF12, EQ5D, Forgotten Joint Score, Satisfaction questionnaire
- Descriptive: Late complications
- Non-invasive Physical Tests: Range of knee movement, knee muscular strength, lower limb kinematics during level (0°)- and downhill (7.5°)-walking
- Conditions
- Knee Osteoarthritis
- Being tested
- Total knee arthroplasty
- Keywords
- Total Knee Arthroplasty, Osteoarthritis, Stability, Knee, Functional Outcome, Gait, Biomechanics
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplastyDevice
Also called Medacta GMK Sphere Implant, DePuy Synthes Attune Implant
Parts of the knee joint diseased by osteoarthritis are replaced by metal and plastic prostheses.
| Study group | Role | What they receive |
|---|---|---|
| Medacta GMK Sphere | Experimental | Half of the patients will be implanted with the Medacta GMK Sphere total knee arthroplasty Receives: Device: Total knee arthroplasty |
| DePuy Synthes Attune | Experimental | Half of the patients will be implanted with the DePuy Attune total knee arthroplasty Receives: Device: Total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Gait Kinematics at 1-Year
Gait of patients will be analysed pre-operatively, six-weeks post-operatively, and 1-year post-operatively by 3D motion capture technology. The change measured over time at 1-year will be the primary outcome.
Measured: Change from baseline at 1-Year
Secondary outcomes (19)
Patient Satisfaction (Pain/Hospital experience/functional ability/Surgery expectations)
Patient satisfaction will be reported using a scale on a questionnaire which asks six questions on how happy patients were with their hospital experience/level of pain/functional ability post-operatively. The questionnaire also asks whether their expectations were met. The two satisfaction questions are answered on a scale of 'Very Satisfied/Satisfied/Unsure/Dissatisfied' by ticking the appropriate box. The four questions based on patient expectation are scored on a scale of 'Excellent/Good/Unsure/Poor' by ticking the appropriate box.
Measured: 1 year post-operatively
Oxford Knee Score (Patient reported outcome measure of pain and function)
A joint specific questionnaire which asks patients on the level of pain and function they believe to have in their affected knee (taking into consideration the past 4 weeks only). The questionnaire consists of 12 questions. Five of the questions are pain related, and seven are aimed at function. Each question has 5 options and is scored from 0-4, with 4 being the best and 0 being the worst pain/function. The best score is therefore 48 (no pain/good function), and the worst score is 0 (pain and poor function).
Measured: Pre-operatively
Oxford Knee Score (Patient reported outcome measure of pain and function)
A joint specific questionnaire which asks patients on the level of pain and function they believe to have in their affected knee (taking into consideration the past 4 weeks only). The questionnaire consists of 12 questions. Five of the questions are pain related, and seven are aimed at function. Each question has 5 options and is scored from 0-4, with 4 being the best and 0 being the worst pain/function. The best score is therefore 48 (no pain/good function), and the worst score is 0 (pain and poor function).
Measured: 6 weeks post-operatively
Oxford Knee Score (Patient reported outcome measure of pain and function)
A joint specific questionnaire which asks patients on the level of pain and function they believe to have in their affected knee (taking into consideration the past 4 weeks only). The questionnaire consists of 12 questions. Five of the questions are pain related, and seven are aimed at function. Each question has 5 options and is scored from 0-4, with 4 being the best and 0 being the worst pain/function. The best score is therefore 48 (no pain/good function), and the worst score is 0 (pain and poor function).
Measured: 1 year post-operatively
EuroQol-5 Dimensions (EQ-5D) (Patient reported outcome measure of patients' perception of their overall health)
A questionnaire on patients' perception of their overall health. The questionnaire focuses on generic health in 5 dimensions: Mobility, self-care, pain or discomfort, anxiety or depression and usual activities (including work, housework, leisure, family, and study). The questions are scored using an algorithm; the result of which relates to the health status of the patient. This score ranges between 0 (equivalent to death) to 1 (equivalent to full health). It also contains a visual analogue scale where patients have to choose on a scale of 0-100 how well they believe their general health to be on that particular day, where 0 is the worst health imaginable and 100 is the best health imaginable.
Measured: Pre-operatively
EuroQol-5 Dimensions (EQ-5D) (Patient reported outcome measure of patients' perception of their overall health)
A questionnaire on patients' perception of their overall health. The questionnaire focuses on generic health in 5 dimensions: Mobility, self-care, pain or discomfort, anxiety or depression and usual activities (including work, housework, leisure, family, and study). The questions are scored using an algorithm; the result of which relates to the health status of the patient. This score ranges between 0 (equivalent to death) to 1 (equivalent to full health). It also contains a visual analogue scale where patients have to choose on a scale of 0-100 how well they believe their general health to be on that particular day, where 0 is the worst health imaginable and 100 is the best health imaginable.
Measured: 6 weeks post-operatively
EuroQol-5 Dimensions (EQ-5D) (Patient reported outcome measure of patients' perception of their overall health)
A questionnaire on patients' perception of their overall health. The questionnaire focuses on generic health in 5 dimensions: Mobility, self-care, pain or discomfort, anxiety or depression and usual activities (including work, housework, leisure, family, and study). The questions are scored using an algorithm; the result of which relates to the health status of the patient. This score ranges between 0 (equivalent to death) to 1 (equivalent to full health). It also contains a visual analogue scale where patients have to choose on a scale of 0-100 how well they believe their general health to be on that particular day, where 0 is the worst health imaginable and 100 is the best health imaginable.
Measured: 1 year post-operatively
Short Form-12 (SF-12) (Patient reported outcome measure of general quality of life)
A general Quality of Life score with 12 questions. It has mental and physical components which are scored from the same questions, using different algorithms. Each question is multiple choice, and the patient must tick one answer. Each answer corresponds to a standardised value, which is used in two algorithms to generate an overall score. One score is for the mental component and one is for the physical component. The physical standardized values are summed across all 12 items. 56.57706 is added to the sum to create the SF-12 physical score. 60.75781 is added to sum create the SF-12 mental score. Higher overall scores are better than lower scores.
Measured: Pre-operatively
Short Form-12 (SF-12) (Patient reported outcome measure of general quality of life)
A general Quality of Life score with 12 questions. It has mental and physical components which are scored from the same questions, using different algorithms. Each question is multiple choice, and the patient must tick one answer. Each answer corresponds to a standardised value, which is used in two algorithms to generate an overall score. One score is for the mental component and one is for the physical component. The physical standardized values are summed across all 12 items. 56.57706 is added to the sum to create the SF-12 physical score. 60.75781 is added to sum create the SF-12 mental score. Higher overall scores are better than lower scores.
Measured: 6 weeks post-operatively
Short Form-12 (SF-12) (Patient reported outcome measure of general quality of life)
A general Quality of Life score with 12 questions. It has mental and physical components which are scored from the same questions, using different algorithms. Each question is multiple choice, and the patient must tick one answer. Each answer corresponds to a standardised value, which is used in two algorithms to generate an overall score. One score is for the mental component and one is for the physical component. The physical standardized values are summed across all 12 items. 56.57706 is added to the sum to create the SF-12 physical score. 60.75781 is added to sum create the SF-12 mental score. Higher overall scores are better than lower scores.
Measured: 1 year post-operatively
Forgotten Joint Score (Patient reported outcome measure of awareness of knee)
This asks questions not covered in the OKS on patient perception of their knee that are important to know following TKA. It focuses on other aspects of outcome other than joint pain and function. There are 12 questions in total, each starting with 'Are you aware of your knee joint...' followed by a daily situation such as driving/lying in bed etc. Each question has a possible of 5 answers: Never/Almost Never/Seldom/Sometimes/Mostly. Every question is scored 1 (never) to 5 (mostly) according to the selected response categories. Thus, the raw score ranges from 12 to 60. The raw score is linearly transformed to a 0-100 scale and then reversed to obtain the final score. For the final Forgotten Joint Score -12 a high score indicates good outcome.
Measured: Pre-operatively
Forgotten Joint Score (Patient reported outcome measure of awareness of knee)
This asks questions not covered in the OKS on patient perception of their knee that are important to know following TKA. It focuses on other aspects of outcome other than joint pain and function. There are 12 questions in total, each starting with 'Are you aware of your knee joint...' followed by a daily situation such as driving/lying in bed etc. Each question has a possible of 5 answers: Never/Almost Never/Seldom/Sometimes/Mostly. Every question is scored 1 (never) to 5 (mostly) according to the selected response categories. Thus, the raw score ranges from 12 to 60. The raw score is linearly transformed to a 0-100 scale and then reversed to obtain the final score. For the final Forgotten Joint Score -12 a high score indicates good outcome.
Measured: 6 weeks post-operatively
Forgotten Joint Score (Patient reported outcome measure of awareness of knee)
This asks questions not covered in the OKS on patient perception of their knee that are important to know following TKA. It focuses on other aspects of outcome other than joint pain and function. There are 12 questions in total, each starting with 'Are you aware of your knee joint...' followed by a daily situation such as driving/lying in bed etc. Each question has a possible of 5 answers: Never/Almost Never/Seldom/Sometimes/Mostly. Every question is scored 1 (never) to 5 (mostly) according to the selected response categories. Thus, the raw score ranges from 12 to 60. The raw score is linearly transformed to a 0-100 scale and then reversed to obtain the final score. For the final Forgotten Joint Score -12 a high score indicates good outcome.
Measured: 1 year post-operatively
Knee Strength
Knee strength in Newton meters will be assessed using motion capture technology and a dynamometer
Measured: Pre-operatively
Knee Strength
Knee strength in Newton meters will be assessed using a dynamometer.
Measured: 6 weeks post-operatively
Knee Strength
Knee strength in Newton meters will be assessed using a dynamometer.
Measured: 1 year post-operatively
Knee range of motion
Knee range of motion in degrees will be assessed using motion capture technology
Measured: Pre-operatively
Knee range of motion
Knee range of motion in degrees will be assessed using motion capture technology
Measured: 6 weeks post-operatively
Knee range of motion
Knee range of motion in degrees will be assessed using motion capture technology.
Measured: 1 year post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start6 Feb 2019
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Medacta International SA
- Responsible party
- Sponsor
- Investigators
- Leela C Biant, FRCSEd Tr & Orth, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618771
- Sponsor's protocol ID
- B00116
- Status last verified
- Jan 2025
- First submitted
- 19 Jun 2018
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Functional Outcomes and Stability of Total Knee Replacement Design Concepts
- ClinicalTrials.gov ID
- NCT03618771
- Acronym / sponsor ID
- B00116
- Conditions
- Knee Osteoarthritis
- Keywords
- Total Knee Arthroplasty, Osteoarthritis, Stability, Knee, Functional Outcome, Gait, Biomechanics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Collaborators
- Medacta International SA
- Study start
- 6 Feb 2019 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 7 Aug 2018 (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.
Total knee replacement (TKR) is an established treatment for knee osteoarthritis and leads to a satisfactory outcome in over 75% of patients. However, up to 25% of patients are not entirely satisfied with their TKR. Patient dissatisfaction has been associated with inadequate functional outcome, especially during negotiation of stairs and slopes. This phenomenon, known as mid-flexion instability, is believed to be caused by excessive anterior-posterior motion of the implant during activities of daily living. This is characterised as a perception that the replaced knee is unsteady during certain tasks.
This study will compare the functional outcome of two implants that have been designed to provide patients with a functionally stable knee throughout its range of motion. The different design roles in preventing implant-related mid-flexion instability remain unknown. The functional outcome and stability of these implants will be tested non-invasively with 3D motion capture technology.
Detailed description
This study will compare the functional outcome of two implants that have been designed to provide patients with a functionally stable knee throughout its range of motion. The different design roles in preventing implant-related mid-flexion instability remain unknown.
The Medacta GMK-Sphere implant consists of a fully congruent medial compartment which allows freedom of movement in the lateral compartment. Both femoral and tibial components are also available in a range of 13 sizes, allowing the surgeon to find a 'best fit' for each patient. These design features are aimed to mimic the movement of a natural healthy knee, potentially preventing implant-related mid-flexion instability.
The DePuy Synthes Attune implant design aims to provide patients with optimal functional outcome. The femoral component of this implant has a gradually reducing radius, and the tibial component an S-shaped post-cam mechanism. These features are designed to facilitate smooth movement and stability during flexion.
The comparative functional outcomes and stability in gait, and other activities of daily living has not been established for the two different TKR design concepts. Functional assessments will be carried out on TKR patients pre- and post-operatively. These assessments will non-invasively quantify the knee's stability, range of motion, strength as well as walking kinematics using 3D motion capture technology. As mid-flexion instability is most notable during downhill walking, patients will be required to walk downhill on a treadmill as part of this study, to better investigate the phenomenon of mid-flexion knee instability.
This study will not involve any invasive procedure in addition to the standard of care. As such, the research burden is minimal. The main ethical issue may be that patients will not be randomised into one of the two proposed groups.
Patients will receive either the GMK-Sphere implant or the Attune implant according to their surgeon's usual practice. Surgeons who specialise in the GMK-Sphere implant will only implant the GMK-Sphere for this study, and surgeons who specialise in the Attune implant will only implant the Attune. This allows surgeons to undertake the prosthesis with which they are expert, and also limit potential surgical error in the case of surgeons having to randomise patients to different designs on the same list.
Patients will be seen by the trial team on 3 separate occasions:
- Routine pre-admission clinic: Recruitment, collection of patient information and questionnaire data and completion of pre-operative physical tests (including gait analysis with 3D motion capture technology)
- Routine post-operation clinic: Six-weeks post-operative physical tests (including gait analysis with 3D motion capture technology) and questionnaire data
- Annual post-operation clinic: 1-year post-operative physical tests (including gait analysis with 3D motion capture technology) and questionnaire data Collection of baseline data during pre-admission clinic (standard care except physical tests):
- Descriptive: Patient demographics (sex, age, height, mass, BMI), diagnosis, pattern of OA, medical co-morbidity
- Questionnaire Data
- Oxford Knee Score - A joint specific questionnaire which asks patients on the level of pain and function they believe to have in their affected knee.
- EQ5D - A questionnaire on patients' perception of their overall health. It contains a visual analogue scale where patients have to choose on a scale of 0-100 how well they believe their general health to be.
- SF12 - A general Quality of Life score. It has mental and physical components.
- Forgotten Joint Score - This asks questions not covered in the OKS on patient perception of their knee that are important to know following TKA. It focuses on other aspects of outcome other than joint pain and function.
- Expectation questionnaire - This asks what the patients expect from the surgery. The investigators use this to gauge whether patients are expecting to achieve too much or too little post-op. This is important for understanding post-operative patient satisfaction. All questionnaires ask different questions (although there is some overlap). Together, they give an overall view of the patients' perception of their general health and knee specific problems. As such, they are all deemed necessary for this investigation. There are separate scoring sheets for these subjective quantitative scores. The results are typically presented as a Mean ± SD score for each questionnaire (provided the data is normally distributed). All are valid in the English language.
- Non-invasive Physical Tests: Range of knee movement, knee muscular strength, lower limb kinematics during level (0°)- and downhill (7.5°)-walking Collection of follow-up measures by trial team between operation and post-operative visit (standard care):
- Surgical complications Collection of data during routine follow-up clinics:
6 weeks post-operation (standard care except physical tests):
- Questionnaire Data: Oxford Knee Score, SF12, EQ5D, Forgotten Joint Score
- Non-invasive Physical Tests: Range of knee movement, knee muscular strength, lower limb kinematics during level (0°)- and downhill (7.5°)-walking 12 weeks post-operation (standard care):
- Descriptive: Radiographic measurement of alignment (Non-invasive) 1 year post-operation (standard care except physical tests):
- Questionnaire Data: Oxford Knee Score, SF12, EQ5D, Forgotten Joint Score, Satisfaction questionnaire
- Descriptive: Late complications
- Non-invasive Physical Tests: Range of knee movement, knee muscular strength, lower limb kinematics during level (0°)- and downhill (7.5°)-walking
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medacta GMK Sphere | Experimental | Device: Total knee arthroplastyHalf of the patients will be implanted with the Medacta GMK Sphere total knee arthroplasty |
| DePuy Synthes Attune | Experimental | Device: Total knee arthroplastyHalf of the patients will be implanted with the DePuy Attune total knee arthroplasty |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of osteoarthritis of the knee which is sufficiently symptomatic to require knee arthroplasty as assessed by their consultant orthopaedic surgeon
Key exclusion criteria (4 listed)
- Inflammatory arthropathy
- Patients requiring bone augmentation
- Patients with collateral ligament incompetence
- Valgus deformity >5 degrees.
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 |
|---|---|---|
| Total knee arthroplastyAlso: Medacta GMK Sphere Implant, DePuy Synthes Attune ImplantParts of the knee joint diseased by osteoarthritis are replaced by metal and plastic prostheses. | Device | DePuy Synthes Attune, Medacta GMK Sphere |
Primary outcome
Change from Baseline Gait Kinematics at 1-Year
Time frame: Change from baseline at 1-Year
Gait of patients will be analysed pre-operatively, six-weeks post-operatively, and 1-year post-operatively by 3D motion capture technology. The change measured over time at 1-year will be the primary outcome.
19 secondary outcomes
Patient Satisfaction (Pain/Hospital experience/functional ability/Surgery expectations)
Time frame: 1 year post-operatively
Oxford Knee Score (Patient reported outcome measure of pain and function)
Time frame: Pre-operatively
Oxford Knee Score (Patient reported outcome measure of pain and function)
Time frame: 6 weeks post-operatively
Oxford Knee Score (Patient reported outcome measure of pain and function)
Time frame: 1 year post-operatively
EuroQol-5 Dimensions (EQ-5D) (Patient reported outcome measure of patients' perception of their overall health)
Time frame: Pre-operatively
EuroQol-5 Dimensions (EQ-5D) (Patient reported outcome measure of patients' perception of their overall health)
Time frame: 6 weeks post-operatively
EuroQol-5 Dimensions (EQ-5D) (Patient reported outcome measure of patients' perception of their overall health)
Time frame: 1 year post-operatively
Short Form-12 (SF-12) (Patient reported outcome measure of general quality of life)
Time frame: Pre-operatively
Short Form-12 (SF-12) (Patient reported outcome measure of general quality of life)
Time frame: 6 weeks post-operatively
Short Form-12 (SF-12) (Patient reported outcome measure of general quality of life)
Time frame: 1 year post-operatively
Forgotten Joint Score (Patient reported outcome measure of awareness of knee)
Time frame: Pre-operatively
Forgotten Joint Score (Patient reported outcome measure of awareness of knee)
Time frame: 6 weeks post-operatively
Forgotten Joint Score (Patient reported outcome measure of awareness of knee)
Time frame: 1 year post-operatively
Knee Strength
Time frame: Pre-operatively
Knee Strength
Time frame: 6 weeks post-operatively
Knee Strength
Time frame: 1 year post-operatively
Knee range of motion
Time frame: Pre-operatively
Knee range of motion
Time frame: 6 weeks post-operatively
Knee range of motion
Time frame: 1 year post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- 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. This study is not recruiting at the moment.
Leela C Biant, FRCSEd Tr & Orth principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total knee arthroplasty in people with Knee Osteoarthritis, run by Manchester University NHS Foundation Trust 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 29 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Gait Kinematics at 1-Year (time frame: Change from baseline at 1-Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2025.