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Kinematic Alignment Compared to Mechanical Alignment Techniques for Total Knee Replacement Surgery (KARMA) (KARMA)

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ClinicalTrials.gov Identifier: NCT03994250
Recruitment Status : Active, not recruiting
First Posted : June 21, 2019
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Brief 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 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.


Condition or disease Intervention/treatment Phase
Osteo Arthritis Knee Other: Kinematic Alignment for total knee replacement surgery Other: Mechanical Alignment for total knee replacement surgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Kinematic Alignment Compared to Mechanical Alignment Techniques for Total Knee Replacement Surgery (KARMA)
Actual Study Start Date : February 10, 2017
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : February 8, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Active Comparator: Kinematic Arm
Kinematic Alignment for TKR surgery
Other: Kinematic Alignment for total knee replacement surgery
Using Kinematic Alignment for total knee replacement surgery
Other Name: Kinematic Arm

Placebo Comparator: Control Arm
Mechanical alignment for TKR surgery
Other: Mechanical Alignment for total knee replacement surgery
Using mechanical alignment for total knee replacement surgery
Other Name: Control Arm




Primary Outcome Measures :
  1. 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

  2. Oxford Knee Score [ Time Frame: up to 6 weeks post surgery ]
    Questionnaire, highest score 48 indicates good mobility and no knee pain

  3. Oxford Knee Score [ Time Frame: up to 1 year post surgery ]
    Questionnaire, highest score 48 indicates good mobility and no knee pain

  4. Oxford Knee Score [ Time Frame: up to 2 years post surgery ]
    Questionnaire, highest score 48 indicates good mobility and no knee pain


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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)

  18. 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)

  19. 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)

  20. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994250


Locations
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United Kingdom
Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Trust
Gobowen, Shropshire, United Kingdom, SY10 7AG
Sponsors and Collaborators
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Investigators
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Principal Investigator: JP Whittaker, FRCS Consultant Orthopaedic Surgeon
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Responsible Party: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
ClinicalTrials.gov Identifier: NCT03994250    
Other Study ID Numbers: RL1 643
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust:
kinematic
mechanical
total knee replacement
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases