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

NCT03994250 | Completed

• 1 other identifier: RL1 643
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteo Arthritis Knee

Keywords

kinematic; mechanical; total knee replacement

Outcome Measures

Primary Outcomes (4)

• Oxford Knee Score measuring current mobility and knee pain

  Questionnaire, highest score 48 indicates good mobility and no knee pain

  Up to 2 weeks prior to surgery

• Oxford Knee Score

  Questionnaire, highest score 48 indicates good mobility and no knee pain

  up to 6 weeks post surgery

• Oxford Knee Score

  Questionnaire, highest score 48 indicates good mobility and no knee pain

  up to 1 year post surgery

• Oxford Knee Score

  Questionnaire, highest score 48 indicates good mobility and no knee pain

  up to 2 years post surgery

Secondary Outcomes (20)

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Up to 2 weeks prior to surgery

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  up to 6 weeks post surgery

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  up to 1 year post surgery

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  up to 2 years post surgery

• Knee Society Score (KSS)

  Up to 2 weeks Prior to surgery

Study Arms (2)

Kinematic Arm

ACTIVE COMPARATOR

Kinematic Alignment for TKR surgery

Other: Kinematic Alignment for total knee replacement surgery

Control Arm

PLACEBO COMPARATOR

Mechanical alignment for TKR surgery

Other: Mechanical Alignment for total knee replacement surgery

Interventions

Kinematic Alignment for total knee replacement surgery OTHER

Using Kinematic Alignment for total knee replacement surgery

Also known as: Kinematic Arm

Kinematic Arm

Mechanical Alignment for total knee replacement surgery OTHER

Using mechanical alignment for total knee replacement surgery

Also known as: Control Arm

Control Arm

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust: lead

Study Sites (1)

Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Trust

Gobowen, Shropshire, SY10 7AG, United Kingdom

Location

Study Officials

• JP Whittaker, FRCS

  Consultant Orthopaedic Surgeon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: June 21, 2019
• Study Start: February 10, 2017
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: April 1, 2021

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)