NCT02178020

Brief Summary

Polyethylene wear and osteolysis remain a concern with the use of modular, fixed bearing total knee arthroplasty. A variety of highly cross-linked polyethylenes have been introduced to decrease this problem, but there is little data on the results and complications of this polyethylene in posterior-stabilized knee prosthesis. The investigators asked the following questions: (1) Are there any differences in the clinical and radiographic results when a highly cross-lined polyethylene is compared to a standard liner? (2) What is the frequency of reoperation in these two groups and are there any specific complications related to highly cross-linked polyethylene liners.

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
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2009

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 30, 2014

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

10 years

First QC Date

June 23, 2014

Last Update Submit

January 31, 2017

Conditions

Arthroplasty, Replacement, Knee

Keywords

Knee ArthroplastyOsteolysisRadiolucent Lines

Outcome Measures

Primary Outcomes (2)

  • Number of Participants requiring revision, or with Device Related Serious Adverse Events

    reoperation rate; polyethylene fracture/failure rate

    Up to 10 years

  • Radiographic osteolysis

    lucent, periarticular lesions , related to polyethylene wear

    up to 10 years

Secondary Outcomes (2)

  • knee scores

    up to 10 years

  • knee joint effusion

    up to 10 years

Other Outcomes (1)

  • LEAS (lower extremity activity score)

    up to 10 years

Study Arms (2)

knee arthroplasty, standard polyethylene

total knee arthroplasty with Standard Compression Molded tibial Polyethylene Liner

Device: knee arthroplasty, standard polyethylene

knee arthroplasty, Highly Cross-Linked (XLP) polyethylene

knee arthroplasty with Highly Cross-Linked tibial Polyethylene Liner

Device: knee arthroplasty, XLP polyethylene

Interventions

knee arthroplasty, standard polyethyleneDEVICE

total knee replacement follow-up; clinical and radiographic; revision rate

Also known as: Zimmer
knee arthroplasty, standard polyethylene
knee arthroplasty, XLP polyethyleneDEVICE

total knee arthroplasty with highly crosslinked polyethylene tibial liner

Also known as: Zimmer: Prolong
knee arthroplasty, Highly Cross-Linked (XLP) polyethylene

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all female and male patients with arthritis of knee that requires total knee arthroplasty

You may qualify if:

  • all patients indicated for primary total posterior stabilized knee arthroplasty

You may not qualify if:

  • patients who refused participation
  • patients who did not comprehend the English language to give informed consent
  • patients with severe knee deformity thought to require a primary constrained condylar prosthesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chapel Hill Orthopedic Surgery and Sports Medicine

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Osteolysis

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Paul F Lachiewicz, MD

    Chapel Hill Orthopedic Surgery and Sports Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2014

First Posted

June 30, 2014

Study Start

July 1, 2009

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

February 1, 2017

Record last verified: 2017-01

Locations

US(1)