Univation X Partial Knee Study

Univation X: A Functional and Clinical Outcomes Study of a Partial Knee Replacement

The objective of this study is to investigate the functional and clinical outcome after medial unicompartmental knee replacement using the Aesculap AG Univation X knee prosthesis compared to pre-operative data and a healthy control group.

Study Overview

• Status: Withdrawn
• Conditions: Arthritis
• Intervention / Treatment: Procedure: Uni-condylar knee arthroplasty

Detailed Description

All potential medial uni-compartmental knee arthroplasty patients from consultant orthopaedic surgeons at the Golden Jubilee National Hospital (GJNH) will be screened in relation to the inclusion/exclusion criteria. Invitation letters and participant information sheets (PIS) will be sent out to suitable patients who have been referred to the GJNH for a knee replacement (allocated patients) prior to their pre-operative consultation with their surgeon. They will be approached at their consultation visit to seek consent to take part in the study. Patients who have been referred to the GJNH for assessment for a knee replacement (see and treat patients) will be approached only if they are deemed eligible for uni-compartmental knee replacement by their consultant, and will be given a copy of the participant information sheet along with the invitation letter. They will be approached for consent to take part in the study at their pre-operative assessment. All patients will be contacted by telephone around a day after receiving the participant information sheet to ask for verbal consent. This is necessary to arrange the pre-operative CT scans and biomechanical testing. All patients will be given the opportunity to ask questions about the study before signing the consent form. Consent will be taken by the chief investigator or their delegate, using a signed form.

Thirty patients will be recruited to the study. They will have their surgery performed by one of the participating consultants using the study implant, the Univation X unicondylar knee system manufactured by Aesculap AG.

Participants will receive their standard in-patient care and rehabilitation. Standard hospital care for knee arthroplasty patients is for them to return to the hospital for a post-operative review at 6 weeks and then 1 year after operation. Study participants will also be asked to attend the GJNH for one additional research specific appointment at two years post-operatively.

During the standard care appointments, patients will be reviewed by a member of the arthroplasty team who will collect routine data on the clinical and functional outcomes and implant stability. These data include the Oxford Knee Score (OKS), EURO Quality of life questionnaire (EQ-5D 5L), patient satisfaction and standard radiographic assessment of the implant.

Detailed radiographic analysis will be carried out on radiographs collected as standard practice and computed tomography (CT) scans taken specifically for the study. Radiographs will be taken pre-operatively, post-operation at day one (standard), 1 year (standard) and the 2 year (study) time points. Patients will have a CT scan pre-operatively and 6 weeks post-operatively. The post-operative scan will be performed instead of the radiographs usually take at this time point. The pre-operative scan will be performed in addition to the pre-operative radiographs.

Study participants will also have two sessions of specialised functional assessment using clinical movement analysis before surgery and 1 year after surgery during their standard pre- and post-operative visits. Biomechanical movement analysis will be carried out in an on-site movement analysis laboratory. Study participants will be required to wear suitable clothing (e.g. tee shirt and shorts) and be barefoot. A number of reflective markers will be attached to specific locations on the body (using suitable double sided tape) which will be tracked by a number of infrared cameras. Participants will be asked to perform the following tasks; level walking, incline walking, decline walking, stand-to-sit-to-stand, step ascent and descent and single leg balance. Each task will be performed at least three times to enable the collection of three good sets of data. In addition, the two stepping tasks will be repeated for each limb. The single leg balance will be performed once for each leg and data will be collected for 30 seconds per limb. A motion capture system will collect limb and torso movements during the task performances while force plates will collect ground reaction forces.

After the two year follow-up appointment the patients involvement in the study will be complete.

• Study Type: Observational

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Male and female participants aged between 45 and 75 inclusive under the care of one of the study surgeons who have been listed for uni-condylar knee replacement surgery. They must live locally enough to be intending returning to the hospital for follow-ups rather than opting to be followed-up locally. They should have a BMI of under 40 otherwise skin artifacts would be an issue for the accuracy of the biomechanical analysis. They must have had no previous lower limb arthroplasty in the previous 12 months or conditions which could influence their mobility other than the condition for which they are having arthroplasty for.

Description

Inclusion Criteria:

• Patients having medial uni-compartmental knee arthroplasty 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 last 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Uni-condylar knee arthroplasty; A cohort of patients who will undergo uni-condylar knee replacement surgery with the Univation X system and have biomechanical anaylsis	Procedure: Uni-condylar knee arthroplasty; Surgical replacement of medial compartment of arthritic knee with an implant; Other Names: uni-condylar knee replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee joint angle during step descent	Knee angles collected using clinical movement analysis	up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxford Knee Score	Patient-reported knee pain and function	Pre-operatively, 6 weeks, 1 year and 2 years post-op
EQ5D-5L	Patient-reported quality of life	Pre-operatively, 6 weeks, 1 year and 2 years post-op
Patient satisfaction	Patient-reported satisfaction of the knee using a five point Likert scale	6 weeks, 1 year and 2 years post-op
Implant survivorship	Percentage of implants still in situ over time.	2 years
Peri-prosthetic lucency	Radiolucent lines (>2mm wide) around the component which may indicate component loosening	6 weeks, 1 year and 2 years post-op
Component position	Migration of the component over time measured from CT scans	6 weeks, 1 year and 2 years post-op
Complications	Any post-operative complications as a result of surgery, e.g. infection, revision, aseptic loosening.	6 weeks, 1 year and 2 years post-op

Collaborators and Investigators

• Sponsor: Golden Jubilee National Hospital
• Collaborators: Aesculap AG
• Investigators: Principal Investigator: Nicholas Ohly, MBBS, Golden Jubilee National Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2020
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): November 1, 2023

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: gait; knee arthroplasty; motion analysis; unicondylar knee replacement; uni-compartmental knee replacement
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: Ortho 17-06

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
• product manufactured in and exported from the U.S.: No