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

Launched by ROBERT JONES AND AGNES HUNT ORTHOPAEDIC AND DISTRICT NHS TRUST · Jun 20, 2019

Keywords

ClinConnect Summary

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...

Gender

ALL

Eligibility 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