Persona Partial Knee Study

June 3, 2021 updated by: Golden Jubilee National Hospital

PPK: A Functional and Clinical Comparison of a Partial and Total Knee Replacement

This study will compare functional and clinical outcomes of partial knee joint replacement using the Persona Partial Knee (PPK) and a standard care total knee replacement. Reported benefits of unicompartmental knee arthroplasty (UKA) compared to total knee arthroplasty (TKA) are less invasive surgery, less post-operative pain, quicker recovery, shorter inpatient stay, preservation of the anterior cruciate ligament (ACL), better knee function and lower risk of complications. Also, the PPK more closely matches the anatomy of knee and has more sizing options. These aim to allow the surgeon to reconstruct the knee to better match the native knee and achieve natural function.

Little data exists which investigates biomechanical function of patients after UKA or comparisons between UKA and TKA and none investigating the PPK. Available data focuses on level walking which is not particularly challenging for these patients and is unlikely to highlight biomechanical differences between UKA and TKA. The investigators will investigate biomechanical differences between UKA and TKA during more challenging activities. These will mirror activities of everyday life: sitting into/rising from a chair, stepping, walking on a slope.

The investigators will investigate level walking as all studies of this nature report these data. Unlike TKA, UKA retains the ACL. The soft tissues of the knee play a role in balance control and the investigators will assess this with single leg balancing. Biomechanical differences will be assessed using 3D motion analysis before and after surgery (6 and 12 months). Comparisons will be made within and between groups and between the patient groups and existing healthy data. Radiographic and patient reported outcomes (satisfaction, pain and functional abilities) will be investigated.

Fifty patients will be recruited and randomised to undergo TKA or UKA. Only patients who are suitable for UKA will be recruited. Data for 25 healthy, matched controls from the investigator's existing healthy control database will be extracted.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

All patients identified as possible participants for the study will be given a "consent to be approached for research" form on arrival at the clinic by the unit co-ordinator. On this, patients can indicate their willingness or otherwise to have the study explained to them. The completed form will be given to their consultant prior to their appointment. Patients who have indicated willingness, and who are deemed suitable for the study following the consultation, will have the study introduced to them by their consultant, who will then ask a member of the research team to fully explain the study. These patients will be given a copy of the Participant Information Sheet (PIS) to take away.

At a later date (at least a day after receiving the PIS), these patients will be contacted by telephone to ask for verbal consent. Patients will also have the opportunity to ask questions about the study. Verbal consent will not be binding, but is necessary to give the research team time to arrange pre-operative study interventions. Written consent will be taken when the patient arrives for the pre-operative biomechanical testing session, once the researcher is happy that the patient is fully informed. Consent will be sought by the principal investigator or one of his delegates.

Standard care for knee arthroplasty patients at the GJNH has them completing the Oxford Knee Score (OKS) and the EQ-5D pre-operatively and at six weeks post-operatively. In addition, satisfaction is measured on a five point Likert scale six weeks post-operatively. Study participants will also be asked to complete these three measures at six and 12 months post-operatively. Two additional questionnaires will be used in the study. The UCLA Activity Score will be used pre-operatively and at six weeks, six months and 12 months post-operatively. The Forgotten Joint Score (FJS) will be used at the three post-operative time points (six week, six months and 12 months).

At 12 months post-operatively, study participants will have two radiographs taken (short AP and lateral views) which are additional to the standard care radiography protocol. The six and 12 month post-operative visits are additional to standard care and, as such, participants will be offered the reimbursement of reasonable travelling costs. Biomechanical assessment using clinical movement analysis (CMA) in the movement analysis laboratory (MAL) at the GJNH will be carried out on three occasions (pre-operatively and at six and 12 months post-operatively). The MAL is a purpose built facility with restricted access for privacy. Changing facilities are provided within the laboratory for participants to change from their outdoor clothes into a T-shirt and shorts for the testing. They will also be asked to perform the testing barefoot. At this point a health care support worker will apply a bandage to the operated knee covering the wound to maintain the blinding of the person collecting the biomechanical data. During these assessments, participants will have a number of small reflective markers attached to their body using toupé tape. The movements of these markers will be tracked by a number of infrared cameras connected to a computer. The data collected in this manner can generate dynamic angles of the joints during the study tasks. In addition, force plates embedded in the floor will measure forces generated during the study tasks which can be converted to forces at each of the joints. During the assessment, participants will be asked to perform a number of activities of daily living; level walking, incline and decline walking, stand-to-sit-to-stand, step ascent and descent and single leg balance. Participants will be asked to perform each task a minimum of three times to ensure that three representative samples of each task are obtained; except for the single leg balance, which will be performed once for each limb. Pre-operative testing will determine baseline function while post-operative assessment will highlight any changes in function.

Following recruitment, participants will be randomised to receive the PPK unicondylar knee implant or the total kneeimplant routinely used in the GJNH. Surgery will be performed as per the surgeons' standard practice using the implant the participant was randomised to receive. After their 12 months follow-up, the participants' involvement in the study will be over.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Dunbartonshire
      • Clydebank, West Dunbartonshire, United Kingdom, G81 4dy
        • Golden Jubilee National Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Suitable for medial unicompartmental knee arthroplasty
  • Aged between 18 and 75 years inclusive
  • Taller than 1.5m in height (the 10th percentile for the population)
  • Functionally intact anterior cruciate ligament
  • Able to give informed consent
  • Able to return to GJNH for follow-up
  • BMI under 40

Exclusion Criteria:

  • Inflammatory joint disease e.g. rheumatoid arthritis
  • Previous hip procedure in the previous twelve months
  • Previous knee surgery other than arthroscopy and medial menisectomy
  • Previous ankle surgery
  • Symptomatic foot, hip or spinal pathology
  • Any medical condition limiting normal ambulation e.g. stroke, Charcot-Marie-Tooth disease, severe lymphedema, advanced cardiac disease
  • Unable to read and understand English and follow verbal and visual instructions unless they can bring a relative or friend to all study assessments to act as a translator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Total knee
Standard care
Device: Stryker Triathlon total knee replacement
Knee arthroplasty using a standard care total knee.
Experimental: Partial knee
Intervention using relatively new partial knee.
Device: Zimmer Biomet Persona Partial Knee unicondylar knee replacement
Knee arthroplasty using the Zimmer Biomet Persona Partial Knee (PPK).
Other Names:
  • Zimmer Biomet Persona Partial Knee (PPK)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee flexion
Time Frame: 12 months post-operatively
Maximum knee flexion in degrees during step descent measured using movement analysis
12 months post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic assessment of component/bone interface stability
Time Frame: 12 months post-operatively
Component position, orientation and signs of loosening using a modified Knee Society Radiographic Assessment Tool (No score produced)
12 months post-operatively
Survivorship
Time Frame: 12 months
Number of implants in situ
12 months
Patient satisfaction: 5 point Likert scale
Time Frame: 12 months post-operatively
Patient satisfaction on a 5 point Likert scale ( Very satisfied, Satisfied, Unsure, Dissatisfied, Very dissatisfied)
12 months post-operatively

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient reported outcome (Oxford Knee Score)
Time Frame: 12 months post-operatively
Patient pain and function measured using the Oxford Knee Score questionnaire (12 to 60, best to worst outcome)
12 months post-operatively
Patient reported outcome (EuroQual 5D-5L questionnaire)
Time Frame: 12 months post-operatively
Change in overall health compared to pre-operatively (Positive change is an improvement. Reported as a weighted index score where max is 1 and min is based on national data)
12 months post-operatively
Patient reported outcome (Forgotten Joint Score)
Time Frame: 12 months post-operatively
Patient awareness of their replacement knee using the Forgotten Joint Score (0-100, poor to good outcome)
12 months post-operatively
Patient reported outcome (University of California Los Angelees Activity Score)
Time Frame: 12 months post-operatively
Patient activity level measured using the UCLA Activity Score (10 item activity grade from worst to best outcome)
12 months post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Golden Jubilee National Hospital

Investigators

  • Principal Investigator: Nichoas Ohlyl, FRCS Ed, Golden Jubilee National Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2021

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

April 1, 2025

Study Registration Dates

First Submitted

July 17, 2019

First Submitted That Met QC Criteria

June 3, 2021

First Posted (Actual)

June 4, 2021

Study Record Updates

Last Update Posted (Actual)

June 4, 2021

Last Update Submitted That Met QC Criteria

June 3, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ortho 18-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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