- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03994250
Kinematic Alignment Compared to Mechanical Alignment Techniques for Total Knee Replacement Surgery (KARMA) (KARMA)
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Shropshire
-
Gobowen, Shropshire, United Kingdom, SY10 7AG
- Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Kinematic Arm
Kinematic Alignment for TKR surgery
|
Using Kinematic Alignment for total knee replacement surgery
Other Names:
|
Placebo Comparator: Control Arm
Mechanical alignment for TKR surgery
|
Using mechanical alignment for total knee replacement surgery
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Up to 2 weeks prior to surgery
|
Oxford Knee Score
Time Frame: up to 6 weeks post surgery
|
Questionnaire, highest score 48 indicates good mobility and no knee pain
|
up to 6 weeks post surgery
|
Oxford Knee Score
Time Frame: up to 1 year post surgery
|
Questionnaire, highest score 48 indicates good mobility and no knee pain
|
up to 1 year post surgery
|
Oxford Knee Score
Time Frame: up to 2 years post surgery
|
Questionnaire, highest score 48 indicates good mobility and no knee pain
|
up to 2 years post surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: Up to 2 weeks prior to surgery
|
Questionnaire, highest score 100% to assess the patient's opinion about their knee and associated problems
|
Up to 2 weeks prior to surgery
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: up to 6 weeks post surgery
|
Questionnaire, highest score 100% to assess the patient's opinion about their knee and associated problems
|
up to 6 weeks post surgery
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: up to 1 year post surgery
|
Questionnaire, highest score 100% to assess the patient's opinion about their knee and associated problems
|
up to 1 year post surgery
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: up to 2 years post surgery
|
Questionnaire, highest score 100% to assess the patient's opinion about their knee and associated problems
|
up to 2 years post surgery
|
Knee Society Score (KSS)
Time Frame: Up to 2 weeks Prior to surgery
|
Questionnaire, +80 Excellent, -60 Poor, Alignment, stability, joint motion of knee, symptoms, patient satisfaction, patient expectations, functional activities, normal, advanced and discretionary activities
|
Up to 2 weeks Prior to surgery
|
Knee Society Score (KSS)
Time Frame: Up to 6 weeks post surgery
|
Questionnaire, +80 Excellent, -60 Poor, Alignment, stability, joint motion of knee, symptoms, patient satisfaction, patient expectations, functional activities, normal, advanced and discretionary activities
|
Up to 6 weeks post surgery
|
Knee Society Score (KSS)
Time Frame: Up to 1 year post surgery
|
Questionnaire, +80 Excellent, -60 Poor, Alignment, stability, joint motion of knee, symptoms, patient satisfaction, patient expectations, functional activities, normal, advanced and discretionary activities
|
Up to 1 year post surgery
|
Knee Society Score (KSS)
Time Frame: Up to 2 years post surgery
|
Questionnaire, +80 Excellent, -60 Poor, Alignment, stability, joint motion of knee, symptoms, patient satisfaction, patient expectations, functional activities, normal, advanced and discretionary activities
|
Up to 2 years post surgery
|
Quality of Life Score (EQ-5D)
Time Frame: Up to 2 weeks Prior to surgery
|
Questionnaire, 1.000 excellent, -0.5 poor, patient mobility, self-care, usual activities, pain/discomfort, anxiety/Depression and patient's view of their health.
|
Up to 2 weeks Prior to surgery
|
Quality of Life Score (EQ-5D)
Time Frame: Up to 6 weeks post surgery
|
Questionnaire, 1.000 excellent, -0.5 poor, patient mobility, self-care, usual activities, pain/discomfort, anxiety/Depression and patient's view of their health.
|
Up to 6 weeks post surgery
|
Quality of Life Score (EQ-5D)
Time Frame: Up to 1 year post surgery
|
Questionnaire, 1.000 excellent, -0.5 poor, patient mobility, self-care, usual activities, pain/discomfort, anxiety/Depression and patient's view of their health.
|
Up to 1 year post surgery
|
Quality of Life Score (EQ-5D)
Time Frame: Up to 2 years post surgery
|
Questionnaire, 1.000 excellent, -0.5 poor, patient mobility, self-care, usual activities, pain/discomfort, anxiety/Depression and patient's view of their health.
|
Up to 2 years post surgery
|
Knee Noise and Front of Knee Pain
Time Frame: Up to 2 weeks prior to surgery
|
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
|
Up to 2 weeks prior to surgery
|
Knee Noise and Front of Knee Pain
Time Frame: Up to 6 weeks post surgery
|
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
|
Up to 6 weeks post surgery
|
Knee Noise and Front of Knee Pain
Time Frame: Up to 1 year post surgery
|
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
|
Up to 1 year post surgery
|
Knee Noise and Front of Knee Pain
Time Frame: Up to 2 years post surgery
|
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
|
Up to 2 years post surgery
|
Patient Knee Implant Performance
Time Frame: Up to 2 weeks Prior to surgery
|
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)
|
Up to 2 weeks Prior to surgery
|
Patient Knee Implant Performance
Time Frame: Up to 6 weeks post surgery
|
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)
|
Up to 6 weeks post surgery
|
Patient Knee Implant Performance
Time Frame: Up to 1 year post surgery
|
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)
|
Up to 1 year post surgery
|
Patient Knee Implant Performance
Time Frame: Up to 2 years post surgery
|
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)
|
Up to 2 years post surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: JP Whittaker, FRCS, Consultant Orthopaedic Surgeon
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RL1 643
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Osteo Arthritis Knee
-
University of PaviaNot yet recruitingLower Limb Arthroplasty: Effects of a Tele Prehabilitation Program With Indirect Electrostimulation.Osteo Arthritis Knee and Hip | Lower Limb ArthroplastyItaly
-
NHS LothianNot yet recruitingOsteo Arthritis Knee | Arthropathy of Knee | Arthritis KneeUnited Kingdom
-
Science and Research Centre KoperSlovenian Research AgencyCompletedOsteo Arthritis Knee | Knee ArthroplastySlovenia
-
Anchen Pharmaceuticals, IncNovum Pharmaceutical Research ServicesCompletedOsteo Arthritis of the KneeUnited States
-
Royal Infirmary of EdinburghUnknownOsteo Arthritis Knee | Arthroplasty, Replacement, KneeUnited Kingdom
-
Vastra Gotaland RegionActive, not recruiting
-
Smith & Nephew, Inc.Terminated
-
CorinRecruitingOsteo Arthritis Knee | Total Knee Arthroplasty | Total Knee Replacement | Knee DiseaseFrance
-
CorinActive, not recruitingOsteo Arthritis Knee | Total Knee Arthroplasty | Total Knee Replacement | Knee DiseaseFrance
-
Medacta USACompletedOsteo Arthritis Knee | Total Knee ArthroplastyUnited States
Clinical Trials on Kinematic Alignment for total knee replacement surgery
-
University of SalfordStockport NHS Foundation TrustSuspendedOutcome After Total Knee ArthroplastyUnited Kingdom
-
University of SalfordStockport NHS Foundation TrustCompletedTotal Knee ArthroplastyUnited Kingdom
-
University of NottinghamMedical Research Council; Aalborg University; Arthritis Research UK; Royal College...UnknownPain | Osteoarthritis | Postoperative Pain | SurgeryUnited Kingdom
-
North York General HospitalRecruitingPain, Postoperative | Knee Replacement, Total | Functional IndependenceCanada
-
University of SalfordStockport NHS Foundation TrustCompletedTotal Knee ArthroplastyUnited Kingdom
-
Istituto Ortopedico RizzoliCompleted
-
University of FloridaNational Institute on Aging (NIA)Completed
-
Northwell HealthCompletedArthroplasty | Total Knee Replacement | PatellaUnited States
-
Limacorporate S.p.aNAMSANot yet recruiting
-
Hospices Civils de LyonRecruiting