NCT02540902

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2015

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
27 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

May 24, 2019

Status Verified

May 1, 2019

Enrollment Period

3.5 years

First QC Date

August 11, 2015

Last Update Submit

May 22, 2019

Conditions

Knee Replacement

Keywords

Knee replacementKnee arthroplastyAll-polyethylene tibiaBone density

Outcome Measures

Primary Outcomes (1)

  • Bone mineral density

    Measure of peri-prosthetic bone mineral density

    18 to 24 months post-operatively

Secondary Outcomes (13)

  • Intra-operative RoM

    Intra-operative

  • Intra-operative alignment

    Intra-operative

  • RoM

    1 year

  • Oxford Knee Score

    1 year

  • EQ-5D

    1 year

  • +8 more secondary outcomes

Study Arms (1)

All-poly

EXPERIMENTAL

Knee arthroplasty with all-polyethylene tibia

Device: All-polyethylene tibia (Aesculap AG)

Interventions

All-polyethylene tibia (Aesculap AG)DEVICE

Implantation of an all polyethylene tibial component.

Also known as: Aesculap All Poly Tibia Plateau Columbus CR DD, NN1200-NN1203, NN1210-NN1213, NN1220-NN1223, NN1230-NN1233, NN1240-NN1243, NN1250-NN1253
All-poly

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Unilateral TKA
  • Aged 70 year or older
  • BMI \< 37.5
  • Suitable to receive the study implant

You may not qualify if:

  • Revision of existing knee replacement
  • Previous lower limb replacement
  • Proximal tibial bone defects
  • Diagnosed osteopenia or osteoporosis
  • Unable to give informed consent
  • Unwilling to take part
  • Unable to return to the Golden Jubilee National Hospital for followup appointments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Golden Jubilee National Hospital

Clydebank, West Dunbartonshire, G81 4DY, United Kingdom

Location

Study Officials

  • Frederic Picard, MD

    Golden Jubilee National Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2015

First Posted

September 4, 2015

Study Start

October 1, 2015

Primary Completion

April 12, 2019

Study Completion

October 1, 2019

Last Updated

May 24, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)