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Traditional Versus Alternative Alignment in TKR

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ClinicalTrials.gov Identifier: NCT03196011
Recruitment Status : Not yet recruiting
First Posted : June 22, 2017
Last Update Posted : April 11, 2018
Sponsor:
Collaborator:
Stryker Nordic
Information provided by (Responsible Party):
Royal Devon and Exeter NHS Foundation Trust

Brief Summary:

As many as 20% of patients are unhappy with the results of total knee replacement (TKR). Various changes to surgical technique have tried to address this but have not led to a significant improvement in the numbers of patients satisfied with their operation.

Recently, attention has focussed on alignment of the leg. When viewed from the front, a number of people do not start with a straight, mechanically aligned leg. Traditionally, when implanting a knee replacement, the surgeon tries to put the shin bone half of the knee replacement perpendicular to the floor to equalise stresses on the in and outside of the joint. However, this may result in the alignment of the leg changing considerably, straining the soft tissues around the knee and contributing to dissatisfaction with TKR.

There has been a move by some surgeons to change practice, and to implant the TKR in a way that replicates the alignment of the patient's own original knee- alternative alignment. Studies looking at alternative alignment have not shown any loss of satisfaction with results of TKR and indeed are showing some signs that in the short term, function of the knee may be better with the new technique.

The research team are planning to run a study comparing the knee replacement used in Exeter- the Triathlon- when put in place using traditional alignment versus using the alternative alignment methods. The outcomes will be assessed in various ways including patient satisfaction questionnaires, measuring muscle strength, flexibility around the knee, and by assessments of alignment of the new knee on X-rays and Computerised Tomography scans. The research team will look at short term results for satisfaction and function of the knee, and in the long term look at wear and survivorship to see if patient satisfaction with TKR can be improved.


Condition or disease Intervention/treatment Phase
Osteo Arthritis Knee Other: TKR with mechanical alignment method Other: TKR with alternative alignment method Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomised controlled trial with 2 intervention arms
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomised, Controlled Study of the Outcomes and Cost Effectiveness of Triathlon CR Knee Replacement System: Traditional Technique Versus Alternative Alignment Method.
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : January 1, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: TKR with mechanical alignment
TKR implanted using traditional alignment methods
Other: TKR with mechanical alignment method
TKR implanted using traditional mechanical alignment methods

Experimental: TKR using alternative alignment method
TKR implanted using alternative alignment methods
Other: TKR with alternative alignment method
TKR implanted using alternative alignment methods




Primary Outcome Measures :
  1. The assessment of difference in knee joint function between the 2 study groups as measured by the Oxford Knee Score.(OKS) [ Time Frame: 1 year after surgery ]
    The OKS is a validated condition specific outcome measure tool.


Secondary Outcome Measures :
  1. An assessment of any significant differences between the 2 arms of the study in limb alignment measured on the full leg alignment X-rays [ Time Frame: 1 year after surgery ]
    Radiological analysis

  2. An assessment of any significant differences between the 2 arms of the study in component positioning measured on the full leg alignment x-ray [ Time Frame: 1 year after surgery ]
    Radiological analysis

  3. An assessment of any significant differences between the 2 arms of the study of positioning of the implants and of joint line position measured on CT scan [ Time Frame: 6 weeks after surgery ]
    Radiological analysis-Measurement on computerised tomography scan (CT)

  4. An assessment of any significant differences between the 2 arms of the study in the assessment of range of motion (ROM) of the knee [ Time Frame: 6 weeks after surgery ]
    Measurement of knee ROM by goniometer

  5. An assessment of any significant differences between the 2 arms of the study in the assessment of range of motion (ROM) of the knee [ Time Frame: 3 months after surgery ]
    Measurement of knee ROM by goniometer

  6. An assessment of any significant differences between the 2 arms of the study in the assessment of range of motion (ROM) of the knee [ Time Frame: 12 months after surgery ]
    Measurement of knee ROM by goniometer

  7. An assessment of any significant differences between the 2 arms of the study in the assessment of range of motion (ROM) of the knee [ Time Frame: 24 months after surgery ]
    Measurement of knee ROM by goniometer

  8. An assessment of any significant differences between the 2 arms of the study in the assessment of range of motion (ROM) of the knee [ Time Frame: 60 months after surgery ]
    Measurement of knee ROM by goniometer

  9. An assessment of any significant differences between the 2 arms of the study when evaluating function of the new knee joint assesses using the Exeter Functional lab protocol including Nurture and InStride accelerometer [ Time Frame: 6 weeks after surgery ]
    Functional lab protocol including Nurture and InStride accelerometer

  10. An assessment of any significant differences between the 2 arms of the study when evaluating function of the new knee joint assesses using the Exeter Functional lab protocol including Nurture and InStride accelerometer [ Time Frame: 3 months after surgery ]
    Functional lab protocol including Nurture and InStride accelerometer

  11. An assessment of any significant differences between the 2 arms of the study when evaluating function of the new knee joint assesses using the Exeter Functional lab protocol including Nurture and InStride accelerometer [ Time Frame: 6 months after surgery ]
    Functional lab protocol including Nurture and InStride accelerometer

  12. An assessment of any significant differences between the 2 arms of the study when evaluating function of the new knee joint assesses using the Exeter Functional lab protocol including Nurture and InStride accelerometer [ Time Frame: 12 months after surgery ]
    Functional lab protocol including Nurture and InStride accelerometer

  13. An assessment of any significant differences between the 2 arms of the study when evaluating function of the new knee joint assesses using the Exeter Functional lab protocol including Nurture and InStride accelerometer [ Time Frame: 24 months after surgery ]
    Functional lab protocol including Nurture and InStride accelerometer

  14. An assessment of any significant differences between the 2 arms of the study when evaluating function of the new knee joint assesses using the Exeter Functional lab protocol including Nurture and InStride accelerometer [ Time Frame: 60 months after surgery ]
    Functional lab protocol including Nurture and InStride accelerometer

  15. An assessment of any significant differences between the 2 arms of the study when analysing the results of the Patient Recorded Outcome Measure called the Knee Osteo-arthritis Outcome Score (KOOS) [ Time Frame: 6 weeks after surgery ]
    Assessment via the validated outcome measure: Knee osteoarthritis outcome score tool

  16. An assessment of any significant differences between the 2 arms of the study when analysing the results of the Patient Recorded Outcome Measure called the Knee Osteo-arthritis Outcome Score (KOOS) [ Time Frame: 6 months after surgery ]
    Assessment via the validated outcome measure: Knee osteoarthritis outcome score tool

  17. An assessment of any significant differences between the 2 arms of the study when analysing the results of the Patient Recorded Outcome Measure called the Knee Osteo-arthritis Outcome Score (KOOS) [ Time Frame: 12 months after surgery ]
    Assessment via the validated outcome measure: Knee osteoarthritis outcome score tool

  18. An assessment of any significant differences between the 2 arms of the study when analysing the results of the Patient Recorded Outcome Measure called the Knee Osteo-arthritis Outcome Score (KOOS) [ Time Frame: 24 months after surgery ]
    Assessment via the validated outcome measure: Knee osteoarthritis outcome score tool

  19. An assessment of any significant differences between the 2 arms of the study when analysing the results of the Patient Recorded Outcome Measure called the Knee Osteo-arthritis Outcome Score (KOOS) [ Time Frame: 60 months after surgery ]
    Assessment via the validated outcome measure: Knee osteoarthritis outcome score tool

  20. An assessment of any significant differences between the 2 arms of the study when analysing the results of the generic Patient Recorded Outcome Measure called the EQ5D [ Time Frame: 6 weeks after surgery ]
    The EQ5D is a validated generic outcome measure

  21. An assessment of any significant differences between the 2 arms of the study when analysing the results of the generic Patient Recorded Outcome Measure called the EQ5D [ Time Frame: 6 months after surgery ]
    The EQ5D is a validated generic outcome measure

  22. An assessment of any significant differences between the 2 arms of the study when analysing the results of the generic Patient Recorded Outcome Measure called the EQ5D [ Time Frame: 12 months after surgery ]
    The EQ5D is a validated generic outcome measure

  23. An assessment of any significant differences between the 2 arms of the study when analysing the results of the generic Patient Recorded Outcome Measure called the EQ5D [ Time Frame: 24 months after surgery ]
    The EQ5D is a validated generic outcome measure

  24. An assessment of any significant differences between the 2 arms of the study when analysing the results of the generic Patient Recorded Outcome Measure called the EQ5D [ Time Frame: 60 months after surgery ]
    The EQ5D is a validated generic outcome measure

  25. An assessment of any significant differences between the 2 arms of the study when analysing the results of the condition specific Patient Recorded Outcome Measure known as the Forgotten Knee Score [ Time Frame: 6 weeks after surgery ]
    Patient recorded outcome measure with a binary yes or no answer to the question: Do you feel like you have forgotten that you have an artificial knee?

  26. An assessment of any significant differences between the 2 arms of the study when analysing the results of the condition specific Patient Recorded Outcome Measure known as the Forgotten Knee Score [ Time Frame: 6 months after surgery ]
    Patient recorded outcome measure with a binary yes or no answer to the question: Do you feel like you have forgotten that you have an artificial knee?

  27. An assessment of any significant differences between the 2 arms of the study when analysing the results of the condition specific Patient Recorded Outcome Measure known as the Forgotten Knee Score [ Time Frame: 12 months after surgery ]
    Patient recorded outcome measure with a binary yes or no answer to the question: Do you feel like you have forgotten that you have an artificial knee?

  28. An assessment of any significant differences between the 2 arms of the study when analysing the results of the condition specific Patient Recorded Outcome Measure known as the Forgotten Knee Score [ Time Frame: 24 months after surgery ]
    Patient recorded outcome measure with a binary yes or no answer to the question: Do you feel like you have forgotten that you have an artificial knee?

  29. An assessment of any significant differences between the 2 arms of the study when analysing the results of the condition specific Patient Recorded Outcome Measure known as the Forgotten Knee Score [ Time Frame: 60 months after surgery ]
    Patient recorded outcome measure with a binary yes or no answer to the question: Do you feel like you have forgotten that you have an artificial knee?

  30. An assessment of any significant differences between the 2 arms of the study when analysing the results of the Patient Recorded Outcome Measure known as the University of California at Los Angeles (UCLA) score [ Time Frame: 6 weeks after surgery ]
    Validated patient recorded outcome measure

  31. An assessment of any significant differences between the 2 arms of the study when analysing the results of the Patient Recorded Outcome Measure known as the University of California at Los Angeles (UCLA) score [ Time Frame: 6 months after surgery ]
    Validated patient recorded outcome measure

  32. An assessment of any significant differences between the 2 arms of the study when analysing the results of the Patient Recorded Outcome Measure known as the University of California at Los Angeles (UCLA) score [ Time Frame: 12 months after surgery ]
    Validated patient recorded outcome measure

  33. An assessment of any significant differences between the 2 arms of the study when analysing the results of the Patient Recorded Outcome Measure known as the University of California at Los Angeles (UCLA) score [ Time Frame: 24 months after surgery ]
    Validated patient recorded outcome measure

  34. An assessment of any significant differences between the 2 arms of the study when analysing the results of the Patient Recorded Outcome Measure known as the University of California at Los Angeles (UCLA) score [ Time Frame: 60 months after surgery ]
    Validated patient recorded outcome measure

  35. An assessment of any significant differences between the 2 arms of the study when analysing the results of the measurement of length of stay (LOS) in hospital [ Time Frame: 1 measurement after discharge from admission to time of discharge from hospital ]
    Measurement of time in hospital

  36. An assessment of any significant differences between the 2 arms of the study when analysing the results of the SF36 generic health outcome questionnaire [ Time Frame: 6 weeks after surgery ]
    The SF36 is a validated, generic patient recorded health outcome questionnaire

  37. An assessment of any significant differences between the 2 arms of the study when analysing the results of the SF36 generic health outcome questionnaire [ Time Frame: 6 months after surgery ]
    The SF36 is a validated, generic patient recorded health outcome questionnaire

  38. An assessment of any significant differences between the 2 arms of the study when analysing the results of the SF36 generic health outcome questionnaire [ Time Frame: 12 after surgery ]
    The SF36 is a validated, generic patient recorded health outcome questionnaire

  39. An assessment of any significant differences between the 2 arms of the study when analysing the results of the SF36 generic health outcome questionnaire [ Time Frame: 24 after surgery ]
    The SF36 is a validated, generic patient recorded health outcome questionnaire

  40. An assessment of any significant differences between the 2 arms of the study when analysing the results of the SF36 generic health outcome questionnaire [ Time Frame: 60 after surgery ]
    The SF36 is a validated, generic patient recorded health outcome questionnaire

  41. An assessment of any significant differences between the 2 arms of the study when analysing the results of the condition specific patient generated outcome measure: the Knee Society Score [ Time Frame: 6 weeks after surgery ]
    Assessment via the validated condition specific outcome measure- the Knee Society Score

  42. An assessment of any significant differences between the 2 arms of the study when analysing the results of the condition specific patient generated outcome measure: the Knee Society Score [ Time Frame: 6 months after surgery ]
    Assessment via the validated condition specific outcome measure- the Knee Society Score

  43. An assessment of any significant differences between the 2 arms of the study when analysing the results of the condition specific patient generated outcome measure: the Knee Society Score [ Time Frame: 12 months after surgery ]
    Assessment via the validated condition specific outcome measure- the Knee Society Score

  44. An assessment of any significant differences between the 2 arms of the study when analysing the results of the condition specific patient generated outcome measure: the Knee Society Score [ Time Frame: 24 months after surgery ]
    Assessment via the validated condition specific outcome measure- the Knee Society Score

  45. An assessment of any significant differences between the 2 arms of the study when analysing the results of the condition specific patient generated outcome measure: the Knee Society Score [ Time Frame: 60 months after surgery ]
    Assessment via the validated condition specific outcome measure- the Knee Society Score


Other Outcome Measures:
  1. An assessment of any significant differences between the 2 arms of the study when comparing the hospital costs of knee replacement surgery [ Time Frame: Study data will be analysed 1 year after discharge from hospital of the last participant- i.e. 3 years after commencement of study. ]
    An attempt to calculate costs of surgery using length of stay data to calculate cost. Day of admission to hospital will be classed as day 1. Day of discharge recorded on the hospital Patient Administration System will be used for calculating the end of hospital stay. Length of stay will be calculated in days.



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.


Ages Eligible for Study:   60 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:• Patients undergoing primary TKR at the RD+E Hospital

  • Patients must have completed a consent form for the study
  • Patients must be prepared to comply with the pre and post-operative investigations, rehabilitation, attendance schedule and questionnaire schedule of the study
  • Patient in whom any varus deformity present is <20°
  • The diagnosis is of tricompartmental osteoarthritis of the knee
  • Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
  • BMI<40
  • Aged =/> 60 years at time of surgery

Exclusion Criteria:• Refusal to consent to the study

  • If the knee for surgery has a fixed flexion deformity ≥15°- this will be assessed by a lateral "heel-hang" x-ray of the knee for surgery
  • If the knee for surgery has a varus deformity ≥20°
  • If the knee for surgery has a valgus deformity i.e. hip/knee/ankle alignment angle <0°
  • Pre-op Oxford Knee Score <8
  • Pre-op knee flexion ability <90°
  • If the natural posterior tibial slope measured is in excess of 10°
  • Any patient whose post-operative recovery or ability to comply with the post-operative rehabilitation and assessment schedules is compromised by known existing other medical conditions
  • Pregnancy
  • Prisoners
  • A patient known to have substance abuse or psychological disorders that could interfere with their ability to comply with the post-operative rehabilitation and assessment schedules
  • Patients unable to read or understand the patient information leaflet and consent form
  • Patient has a known sensitivity to device materials.
  • Patient has a Body Mass Index (BMI) ≥ 40.
  • Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
  • Patient has received any orthopaedic surgical intervention to the lower extremities within the past year or is expected to require any orthopaedic surgical intervention to the lower extremities, other than the TKR to be enrolled in this study, within the next year.
  • Patient requires bilateral total knee replacements, or has a history of unsuccessful contralateral partial or total knee replacement.
  • Patient has chronic heart failure (NYHA Stage ≥ 2)
  • Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
  • Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's disease) leading to progressive bone deterioration.
  • Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
  • Patient requires revision surgery of a previously implanted total knee replacement or knee fusion to the affected joint.

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): NCT03196011


Contacts
Contact: Patrick Hourigan, MCSP 0044 (0)1392 408562 p.hourigan@nhs.net
Contact: Andrew Toms, MSc FRCS 0044 (0)1392 403562 andrewtoms@nhs.net

Sponsors and Collaborators
Royal Devon and Exeter NHS Foundation Trust
Stryker Nordic
Investigators
Principal Investigator: Andrew Toms, MSc FRCS Royal Devon and Exeter Hospital

Publications:

Responsible Party: Royal Devon and Exeter NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03196011     History of Changes
Other Study ID Numbers: 1802588
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases