Study of an All Polyethylene Tibial Component

A Prospective Study of an All Polyethylene Tibial Component Used in Total Knee Arthroplasty Surgery

This will be a prospective single cohort investigation of the Columbus all polyethylene tibia (Aesculap AG, Tuttlingen, Germany) used in total knee arthroplasty (TKA) surgery. The aim of the project is to determine post-operative outcome of the all polyethylene tibia up to two years.

Study Overview

• Status: Unknown
• Conditions: Knee Replacement
• Intervention / Treatment: Device: All-polyethylene tibia (Aesculap AG)

Detailed Description

Thirty consecutive TKA patients under the care of two orthopaedic consultants at the Golden Jubilee National Hospital who meet the inclusion/exclusion criteria will be recruited to the study and will be given the all polyethylene tibia. Participants will return for their standard postoperative followup appointments (6 weeks and 1 year post-operatively). In addition to standard care, a bone density scan using dual energy x-ray absorptiometery (DXA) will be done as part of the 6 weeks post-operative follow-up. A second DXA scan will be done at an additional appointment at the hospital between 18 and 24 months post-operatively for a bone density scan which is not part of standard care.

The data which will be analysed will be the results of the bone scan, computer generated data about the range of movement (RoM) and alignment of the operated knee collected as part of the operation, the RoM, clinical outcome and satisfaction data collected at the pre-operative assessment and post-operative followups, pre- and post-operative x-rays, complications, survivorship and surgeon experience of using the all polyethylene tibia. These data will be investigated to see if the all polyethylene tibia has satisfactory outcomes with no adverse effects.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

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: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Unilateral TKA
2. Aged 70 year or older
3. BMI < 37.5
4. Suitable to receive the study implant

Exclusion Criteria:

1. Revision of existing knee replacement
2. Previous lower limb replacement
3. Proximal tibial bone defects
4. Diagnosed osteopenia or osteoporosis
5. Unable to give informed consent
6. Unwilling to take part
7. Unable to return to the Golden Jubilee National Hospital for followup appointments

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All-poly; Knee arthroplasty with all-polyethylene tibia	Device: All-polyethylene tibia (Aesculap AG); Implantation of an all polyethylene tibial component.; Other Names: Aesculap All Poly Tibia Plateau Columbus CR DD; NN1200-NN1203, NN1210-NN1213, NN1220-NN1223; NN1230-NN1233, NN1240-NN1243, NN1250-NN1253

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone mineral density	Measure of peri-prosthetic bone mineral density	18 to 24 months post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra-operative RoM	Range of movement of the knee joint measured by the navigation computer during surgery	Intra-operative
Intra-operative alignment	The leg alignment measured by the navigation computer during surgery.	Intra-operative
RoM	Active range of motion of the knee joint	1 year
Oxford Knee Score	Clinical outcome measure	1 year
EQ-5D	General health measure	1 year
Patient satisfaction	Patient satisfaction with surgery (Scale: 0 to 10, 0 = not satisfied, 10 = very satisfied)	1 year
Leg alignment	Leg alignment measured from long leg x-rays	1 year
Bone condition	Signs of osteolysis from knee x-rays	1 year
Complications	Any post-operative complications as a result of surgery, e.g. infection, revision, aseptic loosening.	1 year
Implant survivorship	Percentage of implants still in situ over time.	18 to 24 months
Surgeon feedback from surgery	Surgeon experience and issues with using all-polyethylene tibia using an un-validated questionnaire.	intra-operative
Component position	Migration of the component over time measured from x-rays	1 year
Peri-prosthetic lucency	Radiolucent lines (>2mm wide) around the component which may indicate component loosening	1 year

Collaborators and Investigators

• Sponsor: Golden Jubilee National Hospital
• Collaborators: Aesculap AG
• Investigators: Principal Investigator: Frederic Picard, MD, Golden Jubilee National Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): April 12, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: August 11, 2015
• First Submitted That Met QC Criteria: September 3, 2015
• First Posted (Estimate): September 4, 2015

Study Record Updates

• Last Update Posted (Actual): May 24, 2019
• Last Update Submitted That Met QC Criteria: May 22, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Knee replacement; Knee arthroplasty; Bone density; All-polyethylene tibia
• Other Study ID Numbers: Ortho 15-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO