Univation X Partial Knee Study

NCT04913974 | Withdrawn

• 1 other identifier: Ortho 17-06
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arthritis

Keywords

unicondylar knee replacement; uni-compartmental knee replacement; knee arthroplasty; gait; motion analysis

Outcome Measures

Primary Outcomes (1)

• Knee joint angle during step descent

  Knee angles collected using clinical movement analysis

  up to 1 year

Secondary Outcomes (7)

• Oxford Knee Score

  Pre-operatively, 6 weeks, 1 year and 2 years post-op

• EQ5D-5L

  Pre-operatively, 6 weeks, 1 year and 2 years post-op

• Patient satisfaction

  6 weeks, 1 year and 2 years post-op

• Implant survivorship

  2 years

• Peri-prosthetic lucency

  6 weeks, 1 year and 2 years post-op

Study Arms (1)

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

Interventions

Uni-condylar knee arthroplasty PROCEDURE

Surgical replacement of medial compartment of arthritic knee with an implant

Also known as: uni-condylar knee replacement

Uni-condylar knee arthroplasty

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Golden Jubilee National Hospital: lead
• Aesculap AG: collaborator

Study Sites (1)

Golden Jubilee National Hospital

Clydebank, West Dunbartonshire, G81 4dy, United Kingdom

Location

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Nicholas Ohly, MBBS

  Golden Jubilee National Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: June 4, 2021
• Study Start: February 1, 2020
• Primary Completion: July 1, 2023
• Study Completion: November 1, 2023
• Last Updated: June 4, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)