Knee OsteoarthritisSPHERENCT05579951
Bespoke vs Standard Instrumentation in TKR
A study testing Patient specific instrumentation and Conventional in people with Knee Osteoarthritis, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Total knee replacements are operations that are offered to patients who have severe arthritis pain that is affecting daily activities that is no longer controlled with painkillers. The operation will replace the worn joints with metal implants and a plastic spacer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Patient specific instrumentation and Conventional
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Sep 2021to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with osteoarthritis of the knee which is sufficiently symptomatic to require knee arthroplasty as assessed by their consultant orthopaedic surgeon
Who cannot join
- Patients with inflammatory arthropathy, patients requiring bone augmentation, patients with ligament incompetence or valgus deformity >5 degrees.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Control Trial of Patient Specific Instrumentation vs Standard Instrumentation of the GMK-Sphere (Global Medacta Knee) Total Knee Arthroplasty
Total knee replacements are operations that are offered to patients who have severe arthritis pain that is affecting daily activities that is no longer controlled with painkillers. The operation will replace the worn joints with metal implants and a plastic spacer. Total knee replacements are successful operations in the vast majority of patients. However, a small minority of patients are not entirely satisfied with the outcome of their knee replacement. Researchers are studying whether the precise positioning of the implant has an effect on the outcome.
This study will look at whether patient-specific instrumentation improves implant position and if it leads to improved patient function so that we know what to recommend in the future.
- Conditions
- Knee Osteoarthritis
- Being tested
- Patient specific instrumentation, Conventional
- Keywords
- Total knee arthroplasty, Stability, Osteoarthritis, Knee, Functional Outcome, Gait, Patient Specific Instrumentation
- 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.
Patient specific instrumentationProcedure or surgery
Total knee replacement with patient specific instrumentation
ConventionalProcedure or surgery
Total knee replacement with conventional instrumentation
Patient specific instrumentationDevice
Medacta GMK Sphere MyKnee Patient specific Instrumentation
| Study group | Role | What they receive |
|---|---|---|
| Conventional | Active comparator | Total knee replacement with conventional instrumentation Receives: Procedure: Conventional |
| Patient specific instrumentation | Active comparator | Total knee replacement with patient specific instrumentation Receives: Procedure: Patient specific instrumentation; Device: Patient specific instrumentation |
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: 1 year post-operatively
Secondary outcomes (9)
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: 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: 6 weeks post-operatively
EuroQol-5 Dimensions (EQ-5D) (Patient reported outcome measure of patients'
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: 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
Knee range of motion
Knee range of motion in degrees will be assessed using a goniometer
Measured: 6 weeks post-operatively
Knee range of motion
Knee range of motion in degrees will be assessed using a goniometer
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 posted14 Oct 2022
- Study start21 Sep 2021
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- University of Manchester
- Responsible party
- Sponsor
- Investigators
- Leela Biant, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579951
- Sponsor's protocol ID
- R04611
- Acronym
- SPHERE
- Status last verified
- Jan 2025
- First submitted
- 11 Oct 2022
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study protocol and participant facing documents can be shared to other researchers upon request to the research team. Requests can be emailed to MORE@manchester.ac.uk
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
- Randomised Control Trial of Patient Specific Instrumentation vs Standard Instrumentation of the GMK-Sphere (Global Medacta Knee) Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05579951
- Acronym / sponsor ID
- SPHERE / R04611
- Conditions
- Knee Osteoarthritis
- Keywords
- Total knee arthroplasty, Stability, Osteoarthritis, Knee, Functional Outcome, Gait, Patient Specific Instrumentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Collaborators
- University of Manchester
- Study start
- 21 Sep 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 14 Oct 2022 (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 replacements are operations that are offered to patients who have severe arthritis pain that is affecting daily activities that is no longer controlled with painkillers. The operation will replace the worn joints with metal implants and a plastic spacer. Total knee replacements are successful operations in the vast majority of patients. However, a small minority of patients are not entirely satisfied with the outcome of their knee replacement. Researchers are studying whether the precise positioning of the implant has an effect on the outcome.
This study will look at whether patient-specific instrumentation improves implant position and if it leads to improved patient function so that we know what to recommend in the future.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional | Active comparator | Procedure: ConventionalTotal knee replacement with conventional instrumentation |
| Patient specific instrumentation | Active comparator | Procedure: Patient specific instrumentation, Device: Patient specific instrumentationTotal knee replacement with patient specific instrumentation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with osteoarthritis of the knee which is sufficiently symptomatic to require knee arthroplasty as assessed by their consultant orthopaedic surgeon
Key exclusion criteria (1 listed)
- Patients with inflammatory arthropathy, patients requiring bone augmentation, patients with ligament incompetence or 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 |
|---|---|---|
| Patient specific instrumentationTotal knee replacement with patient specific instrumentation | Procedure or surgery | Patient specific instrumentation |
| ConventionalTotal knee replacement with conventional instrumentation | Procedure or surgery | Conventional |
| Patient specific instrumentationMedacta GMK Sphere MyKnee Patient specific Instrumentation | Device | Patient specific instrumentation |
Primary outcome
Change from Baseline Gait Kinematics at 1-Year
Time frame: 1 year post-operatively
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.
9 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: 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: 6 weeks post-operatively
EuroQol-5 Dimensions (EQ-5D) (Patient reported outcome measure of patients'
Time frame: 1 year post-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
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. Study protocol and participant facing documents can be shared to other researchers upon request to the research team. Requests can be emailed to MORE@manchester.ac.uk
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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 Biant 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 Patient specific instrumentation and Conventional 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 1 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: 1 year post-operatively). 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.