Osteo Arthritis KneeKARMANCT03994250
Kinematic Alignment Compared to Mechanical Alignment Techniques for Total Knee Replacement Surgery (KARMA)
A study testing Kinematic Alignment for total knee replacement surgery and Mechanical Alignment for total knee replacement surgery in people with Osteo Arthritis Knee, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust at 1 site in United Kingdom.
Trial summary
Total knee replacement (TKR) is a bony and soft-tissue procedure and much attention has been given to the alignment of the components, which is relatively easy to quantify. Recently, substantial healthcare resources have been devoted to the development and use of computer navigation and patient-specific… Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Kinematic Alignment for total knee replacement surgery and Mechanical Alignment for total knee replacement surgery
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Feb 2017to 1 Jan 2021
- 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 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female between the age of 22 and 80 years inclusive
- Diagnosis of non-inflammatory degenerative joint disease
- Suitable candidate for cemented primary total knee arthroplasty
- Voluntary, informed consent to participate in the study
- Subject is not currently bedridden
- Able to understand (in the opinion of the clinical investigator) the clinical investigation and co-operate with clinical investigations
- Subject is able to comfortably speak, read and understand questions
Who cannot join
- Females who are pregnant or lactating
- Contralateral knee already enrolled in the study
- Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee
- Contralateral amputation
- Currently experiencing radicular pain from the spine
- Participated in a study with an investigational product in the last 3 months
Show all 12Show fewer
- Currently involved in any personal injury litigation, medical-legal or workers compensation claims
- Known drug or alcohol abuser or a psychological disorder that could affect their ability to complete patient reported questionnaires
- Diagnosed with fibromyalgia that is currently being treated with prescription medication
- Significant neurological or musculoskeletal disorders or disease that may adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis, Charcot disease)
- Suffering with inflammatory arthritis (e.g. rheumatoid arthritis, juvenile rheumatoid arthritis,psoriatic arthritis, systemic lupus erythematosus
- Medical condition with less than 2 years life expectancy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Trust
Gobowen, Shropshire, SY10 7AG
About this study
Total knee replacement (TKR) is a bony and soft-tissue procedure and much attention has been given to the alignment of the components, which is relatively easy to quantify. Recently, substantial healthcare resources have been devoted to the development and use of computer navigation and patient-specific instrumentation systems that achieve neutral mechanical alignment. However the conventional assumption that mechanically aligned TKR leads to the best implant survival has been brought into doubt. Although mechanically aligned TKR improves function, 20 % of patients remain dissatisfied according to reports from Canada, England and Wales.
In an attempt to improve patient satisfaction recent developments have included the individualization of component alignment with the goal of achieving pre-arthritic alignment through restoration of the axes of rotation, a technique called kinematic alignment (KA). The outcomes of kinematic alignment have been assessed in case series but so far only one randomised controlled trial (RCT) [Digital Object Identifier (DOI)10.1302/0301-620X.96B7.32812 Published 1 July 2014] undertaken in the USA has compared the clinical results of kinematic alignment using patient-specific instruments with the traditional technique of mechanical alignment, demonstrating a substantial benefit in postoperative patient pain relief and function. Therefore, for direct comparison between kinematic aligned and mechanically aligned surgical techniques for total knee replacement, the investigators would like to undertake a pilot study prior to a larger RCT and recruit a cohort of 15 patients undergoing kinematical aligned TKR. The investigators will use the same device as was used in a previous mechanically aligned study undertaken at our hospital (REC ref: 12/NE/0293 Attune, DePuy, Warsaw IN, in 35 patients based on the same eligibility criteria who will act as controls), which will allow the opportunity to estimate the standard deviation in the control arm in preparation for the larger RCT.
Read the detailed description
In order to be able to undertake a randomized controlled trial (RCT) comparing the efficacy of kinematic alignment versus conventional mechanical alignment for total knee replacement a robust assessment of the expected standard deviation of the primary outcome measure (Oxford Knee Score [OKS]) in both arms of the proposed RCT must be undertaken, hence this pilot study.
To determine whether there are improved postoperative outcomes in the investigative arm using the following patient reported outcomes: Knee Implant Performance (PKIP - pre and post surgical), Knee Injury and Osteoarthritis Outcome Score (KOOS), Knee Society Score (KSS), Knee Noise and Front of Knee Pain Score and Quality of Life score EQ-5D which will be completed at baseline(pre-operatively) and post-operatively at 6 weeks (normal clinical follow up), 1 year (normal clinical follow up) and 2 years. In addition, x-rays of the knee (AP, lateral \& skyline) will be taken at the same time. These outcomes are identical to the data collected in the previous mechanically aligned study which will be used as the control arm.
Much attention has been given to the alignment of the components in total knee replacement (TKR) and this is relatively easy to quantify, particularly in the coronal plane. However, due to the development and use of computer navigation and patient-specific instrumentation systems that achieve neutral mechanical alignment, the conventional assumption that mechanically aligned TKR leads to the best implant survival has been brought into doubt. Although mechanically aligned TKR improves function, 20 % of patients remain dissatisfied according to reports from Canada, England and Wales. The relationship between in-range and varus (turned inward toward the mid line of the body to an abnormal degree) and valgus (turned outward) outlier categories of the limb and implant survival of a primary total knee replacement is weak at 15 years. Leaving a limb, knee, or tibial component within a natural range of varus does not reduce implant survival at 3, 5, 7, and 10 years.
With the development of individualization of component alignment and the goal of achieving pre-arthritic alignment through restoration of the axes of rotation, the kinematic alignment technique has shown in case series and one RCT in the USA a substantial benefit in postoperative patient pain relief and function.
For direct comparison between kinematic aligned and mechanically aligned surgical techniques for total knee replacement, the investigators will conduct a pilot study prior to a larger RCT and recruit a cohort of 15 patients undergoing kinematic aligned TKR. The investigators will use the same device as was used in a previous mechanically aligned study undertaken at our hospital (REC ref: 12/NE/0293 Attune, DePuy, Warsaw IN, in 35 patients based on the same eligibility criteria who will act as controls), which will allow the opportunity to estimate the standard deviation in the control arm in preparation for the larger RCT.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Kinematic Alignment for total knee replacement surgery, Mechanical Alignment for total knee replacement surgery
- Keywords
- kinematic, mechanical, total knee replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinematic Alignment for total knee replacement surgeryOther
Also called Kinematic Arm
Using Kinematic Alignment for total knee replacement surgery
Mechanical Alignment for total knee replacement surgeryOther
Also called Control Arm
Using mechanical alignment for total knee replacement surgery
| Study group | Role | What they receive |
|---|---|---|
| Kinematic Arm | Active comparator | Kinematic Alignment for TKR surgery Receives: Other: Kinematic Alignment for total knee replacement surgery |
| Control Arm | Placebo comparator | Mechanical alignment for TKR surgery Receives: Other: Mechanical Alignment for total knee replacement surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Knee Score measuring current mobility and knee pain
Questionnaire, highest score 48 indicates good mobility and no knee pain
Measured: Up to 2 weeks prior to surgery
Oxford Knee Score
Questionnaire, highest score 48 indicates good mobility and no knee pain
Measured: up to 6 weeks post surgery
Oxford Knee Score
Questionnaire, highest score 48 indicates good mobility and no knee pain
Measured: up to 1 year post surgery
Oxford Knee Score
Questionnaire, highest score 48 indicates good mobility and no knee pain
Measured: up to 2 years post surgery
Secondary outcomes (20)
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Questionnaire, highest score 100% to assess the patient's opinion about their knee and associated problems
Measured: Up to 2 weeks prior to surgery
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Questionnaire, highest score 100% to assess the patient's opinion about their knee and associated problems
Measured: up to 6 weeks post surgery
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Questionnaire, highest score 100% to assess the patient's opinion about their knee and associated problems
Measured: up to 1 year post surgery
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Questionnaire, highest score 100% to assess the patient's opinion about their knee and associated problems
Measured: up to 2 years post surgery
Knee Society Score (KSS)
Questionnaire, +80 Excellent, -60 Poor, Alignment, stability, joint motion of knee, symptoms, patient satisfaction, patient expectations, functional activities, normal, advanced and discretionary activities
Measured: Up to 2 weeks Prior to surgery
Knee Society Score (KSS)
Questionnaire, +80 Excellent, -60 Poor, Alignment, stability, joint motion of knee, symptoms, patient satisfaction, patient expectations, functional activities, normal, advanced and discretionary activities
Measured: Up to 6 weeks post surgery
Knee Society Score (KSS)
Questionnaire, +80 Excellent, -60 Poor, Alignment, stability, joint motion of knee, symptoms, patient satisfaction, patient expectations, functional activities, normal, advanced and discretionary activities
Measured: Up to 1 year post surgery
Knee Society Score (KSS)
Questionnaire, +80 Excellent, -60 Poor, Alignment, stability, joint motion of knee, symptoms, patient satisfaction, patient expectations, functional activities, normal, advanced and discretionary activities
Measured: Up to 2 years post surgery
Quality of Life Score (EQ-5D)
Questionnaire, 1.000 excellent, -0.5 poor, patient mobility, self-care, usual activities, pain/discomfort, anxiety/Depression and patient's view of their health.
Measured: Up to 2 weeks Prior to surgery
Quality of Life Score (EQ-5D)
Questionnaire, 1.000 excellent, -0.5 poor, patient mobility, self-care, usual activities, pain/discomfort, anxiety/Depression and patient's view of their health.
Measured: Up to 6 weeks post surgery
Quality of Life Score (EQ-5D)
Questionnaire, 1.000 excellent, -0.5 poor, patient mobility, self-care, usual activities, pain/discomfort, anxiety/Depression and patient's view of their health.
Measured: Up to 1 year post surgery
Quality of Life Score (EQ-5D)
Questionnaire, 1.000 excellent, -0.5 poor, patient mobility, self-care, usual activities, pain/discomfort, anxiety/Depression and patient's view of their health.
Measured: Up to 2 years post surgery
Knee Noise and Front of Knee Pain
Questionnaire detecting crepitus in the knees which may be caused by a meniscus tear or chondromalacia patellais, for example, a dull ache behind the kneecap
Measured: Up to 2 weeks prior to surgery
Knee Noise and Front of Knee Pain
Questionnaire detecting crepitus in the knees which may be caused by a meniscus tear or chondromalacia patellais, for example, a dull ache behind the kneecap
Measured: Up to 6 weeks post surgery
Knee Noise and Front of Knee Pain
Questionnaire detecting crepitus in the knees which may be caused by a meniscus tear or chondromalacia patellais, for example, a dull ache behind the kneecap
Measured: Up to 1 year post surgery
Knee Noise and Front of Knee Pain
Questionnaire detecting crepitus in the knees which may be caused by a meniscus tear or chondromalacia patellais, for example, a dull ache behind the kneecap
Measured: Up to 2 years post surgery
Patient Knee Implant Performance
Questionnaire, 0 - 100 (higher better knee function) 4 subscales (Confidence, stability, modify activities and satisfaction) each with score of 0 - 10 (latter better knee function)
Measured: Up to 2 weeks Prior to surgery
Patient Knee Implant Performance
Questionnaire, 0 - 100 (higher better knee function) 4 subscales (Confidence, stability, modify activities and satisfaction) each with score of 0 - 10 (latter better knee function)
Measured: Up to 6 weeks post surgery
Patient Knee Implant Performance
Questionnaire, 0 - 100 (higher better knee function) 4 subscales (Confidence, stability, modify activities and satisfaction) each with score of 0 - 10 (latter better knee function)
Measured: Up to 1 year post surgery
Patient Knee Implant Performance
Questionnaire, 0 - 100 (higher better knee function) 4 subscales (Confidence, stability, modify activities and satisfaction) each with score of 0 - 10 (latter better knee function)
Measured: Up to 2 years post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start10 Feb 2017
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- JP Whittaker, FRCS, Principal investigator, Consultant Orthopaedic Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994250
- Sponsor's protocol ID
- RL1 643
- Acronym
- KARMA
- Status last verified
- Mar 2020
- First submitted
- 15 Jan 2019
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinematic Alignment Compared to Mechanical Alignment Techniques for Total Knee Replacement Surgery (KARMA)
- ClinicalTrials.gov ID
- NCT03994250
- Acronym / sponsor ID
- KARMA / RL1 643
- Conditions
- Osteo Arthritis Knee
- Keywords
- kinematic, mechanical, total knee replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS TrustOther government
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 21 Jun 2019 (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 a bony and soft-tissue procedure and much attention has been given to the alignment of the components, which is relatively easy to quantify. Recently, substantial healthcare resources have been devoted to the development and use of computer navigation and patient-specific instrumentation systems that achieve neutral mechanical alignment. However the conventional assumption that mechanically aligned TKR leads to the best implant survival has been brought into doubt. Although mechanically aligned TKR improves function, 20 % of patients remain dissatisfied according to reports from Canada, England and Wales.
In an attempt to improve patient satisfaction recent developments have included the individualization of component alignment with the goal of achieving pre-arthritic alignment through restoration of the axes of rotation, a technique called kinematic alignment (KA). The outcomes of kinematic alignment have been assessed in case series but so far only one randomised controlled trial (RCT) [Digital Object Identifier (DOI)10.1302/0301-620X.96B7.32812 Published 1 July 2014] undertaken in the USA has compared the clinical results of kinematic alignment using patient-specific instruments with the traditional technique of mechanical alignment, demonstrating a substantial benefit in postoperative patient pain relief and function. Therefore, for direct comparison between kinematic aligned and mechanically aligned surgical techniques for total knee replacement, the investigators would like to undertake a pilot study prior to a larger RCT and recruit a cohort of 15 patients undergoing kinematical aligned TKR. The investigators will use the same device as was used in a previous mechanically aligned study undertaken at our hospital (REC ref: 12/NE/0293 Attune, DePuy, Warsaw IN, in 35 patients based on the same eligibility criteria who will act as controls), which will allow the opportunity to estimate the standard deviation in the control arm in preparation for the larger RCT.
Detailed description
In order to be able to undertake a randomized controlled trial (RCT) comparing the efficacy of kinematic alignment versus conventional mechanical alignment for total knee replacement a robust assessment of the expected standard deviation of the primary outcome measure (Oxford Knee Score [OKS]) in both arms of the proposed RCT must be undertaken, hence this pilot study.
To determine whether there are improved postoperative outcomes in the investigative arm using the following patient reported outcomes: Knee Implant Performance (PKIP - pre and post surgical), Knee Injury and Osteoarthritis Outcome Score (KOOS), Knee Society Score (KSS), Knee Noise and Front of Knee Pain Score and Quality of Life score EQ-5D which will be completed at baseline(pre-operatively) and post-operatively at 6 weeks (normal clinical follow up), 1 year (normal clinical follow up) and 2 years. In addition, x-rays of the knee (AP, lateral \& skyline) will be taken at the same time. These outcomes are identical to the data collected in the previous mechanically aligned study which will be used as the control arm.
Much attention has been given to the alignment of the components in total knee replacement (TKR) and this is relatively easy to quantify, particularly in the coronal plane. However, due to the development and use of computer navigation and patient-specific instrumentation systems that achieve neutral mechanical alignment, the conventional assumption that mechanically aligned TKR leads to the best implant survival has been brought into doubt. Although mechanically aligned TKR improves function, 20 % of patients remain dissatisfied according to reports from Canada, England and Wales. The relationship between in-range and varus (turned inward toward the mid line of the body to an abnormal degree) and valgus (turned outward) outlier categories of the limb and implant survival of a primary total knee replacement is weak at 15 years. Leaving a limb, knee, or tibial component within a natural range of varus does not reduce implant survival at 3, 5, 7, and 10 years.
With the development of individualization of component alignment and the goal of achieving pre-arthritic alignment through restoration of the axes of rotation, the kinematic alignment technique has shown in case series and one RCT in the USA a substantial benefit in postoperative patient pain relief and function.
For direct comparison between kinematic aligned and mechanically aligned surgical techniques for total knee replacement, the investigators will conduct a pilot study prior to a larger RCT and recruit a cohort of 15 patients undergoing kinematic aligned TKR. The investigators will use the same device as was used in a previous mechanically aligned study undertaken at our hospital (REC ref: 12/NE/0293 Attune, DePuy, Warsaw IN, in 35 patients based on the same eligibility criteria who will act as controls), which will allow the opportunity to estimate the standard deviation in the control arm in preparation for the larger RCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinematic Arm | Active comparator | Other: Kinematic Alignment for total knee replacement surgeryKinematic Alignment for TKR surgery |
| Control Arm | Placebo comparator | Other: Mechanical Alignment for total knee replacement surgeryMechanical alignment for TKR surgery |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female between the age of 22 and 80 years inclusive
- Diagnosis of non-inflammatory degenerative joint disease
- Suitable candidate for cemented primary total knee arthroplasty
- Voluntary, informed consent to participate in the study
- Subject is not currently bedridden
Key exclusion criteria (12 listed)
- Females who are pregnant or lactating
- Contralateral knee already enrolled in the study
- Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee
- Contralateral amputation
- Currently experiencing radicular pain from the spine
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 |
|---|---|---|
| Kinematic Alignment for total knee replacement surgeryAlso: Kinematic ArmUsing Kinematic Alignment for total knee replacement surgery | Other | Kinematic Arm |
| Mechanical Alignment for total knee replacement surgeryAlso: Control ArmUsing mechanical alignment for total knee replacement surgery | Other | Control Arm |
Primary outcome
Oxford Knee Score measuring current mobility and knee pain
Time frame: Up to 2 weeks prior to surgery
Questionnaire, highest score 48 indicates good mobility and no knee pain
Oxford Knee Score
Time frame: up to 6 weeks post surgery
Questionnaire, highest score 48 indicates good mobility and no knee pain
Oxford Knee Score
Time frame: up to 1 year post surgery
Questionnaire, highest score 48 indicates good mobility and no knee pain
Oxford Knee Score
Time frame: up to 2 years post surgery
Questionnaire, highest score 48 indicates good mobility and no knee pain
20 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Up to 2 weeks prior to surgery
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: up to 6 weeks post surgery
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: up to 1 year post surgery
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: up to 2 years post surgery
Knee Society Score (KSS)
Time frame: Up to 2 weeks Prior to surgery
Knee Society Score (KSS)
Time frame: Up to 6 weeks post surgery
Knee Society Score (KSS)
Time frame: Up to 1 year post surgery
Knee Society Score (KSS)
Time frame: Up to 2 years post surgery
Quality of Life Score (EQ-5D)
Time frame: Up to 2 weeks Prior to surgery
Quality of Life Score (EQ-5D)
Time frame: Up to 6 weeks post surgery
Quality of Life Score (EQ-5D)
Time frame: Up to 1 year post surgery
Quality of Life Score (EQ-5D)
Time frame: Up to 2 years post surgery
Knee Noise and Front of Knee Pain
Time frame: Up to 2 weeks prior to surgery
Knee Noise and Front of Knee Pain
Time frame: Up to 6 weeks post surgery
Knee Noise and Front of Knee Pain
Time frame: Up to 1 year post surgery
Knee Noise and Front of Knee Pain
Time frame: Up to 2 years post surgery
Patient Knee Implant Performance
Time frame: Up to 2 weeks Prior to surgery
Patient Knee Implant Performance
Time frame: Up to 6 weeks post surgery
Patient Knee Implant Performance
Time frame: Up to 1 year post surgery
Patient Knee Implant Performance
Time frame: Up to 2 years post surgery
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 1 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Osteo Arthritis Knee
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
Not yet recruiting
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
Not yet recruitingPhase 3
A Study to Evaluate Efficacy and Safety of a Single Intra-Articular Injection of HL-01 in the Treatment of Pain in Symptomatic Knee Osteoarthritis
Osteo Arthritis of the Knee
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Recruiting
Total Versus Robotic Assisted Unicompartmental Knee Replacement
Osteo Arthritis Knee, Arthritis Knee
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.
JP Whittaker, FRCS principal investigator
Consultant Orthopaedic Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinematic Alignment for total knee replacement surgery and Mechanical Alignment for total knee replacement surgery in people with Osteo Arthritis Knee, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS 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 7 inclusion and 12 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 1 Apr 2021. 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. Some participants in this study may receive a placebo. 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?
Oxford Knee Score measuring current mobility and knee pain (time frame: Up to 2 weeks prior to surgery). The study lists 4 primary outcomes in all. 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 1 Apr 2021; AzTrials last refreshed its copy on 4 Nov 2026.