NCT01947686

Brief Summary

The purpose of the study is to determine the survivorship rate of robotically guided isolated patellofemoral implants at 2, 5 and 10 year postoperative.

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
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2013

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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

February 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2013

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

September 5, 2018

Status Verified

September 1, 2018

Enrollment Period

10 years

First QC Date

September 17, 2013

Last Update Submit

September 4, 2018

Conditions

Patellofemoral Knee Arthroplasty

Keywords

osteoarthritis, patellofemoral

Outcome Measures

Primary Outcomes (1)

  • 10 year survivorship of robotically guided isolated patellofemoral implants.

    10 year survivorship of robotically guided isolated patellofemoral implants at 2,5, and 10 year follow up.

    10 years after surgery

Secondary Outcomes (2)

  • 2 year survivorship of robotically guided isolated patellofemoral implants.

    2 years after surgery

  • 5 year survivorship of robotically guided isolated patellofemoral implants.

    5 years after surgery

Study Arms (1)

Patellofemoral Knee Arthroplasty

Patient who have received a robotically guided isolated patellofemoral implant.

Device: Robotically guided patellofemoral UKA isolated patellofemoral implants

Interventions

Robotically guided patellofemoral UKA isolated patellofemoral implantsDEVICE

A robot guided isolated patellofemoral unicompartmental knee arthroplasty procedures to replace only the patellofemoral component of the knee.

Patellofemoral Knee Arthroplasty

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent a primary robotically guided UKA and received an isolated patellofemoral implant.

You may qualify if:

  • Over 21 years of age underwent primary robotically guided UKA and received an isolated patellofemoral implant at least 24 months post operative as of February 2013

You may not qualify if:

  • Patient will be excluded from participation in the study if they are cognitively unable to answer study questions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St. Helena Hospital Coon Joint Replacement Institute

St. Helena, California, 94574, United States

Location

Rebound Orthopedics and Neurosurgery

Vancouver, Washington, 98686, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Thomas Coon, MD

    St. Helena Hospital Coon Joint Replacement

    STUDY DIRECTOR

  • Todd Borus, MD

    Rebound Orthopedics and Neurosurgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2013

First Posted

September 20, 2013

Study Start

February 1, 2013

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

September 5, 2018

Record last verified: 2018-09

Locations

US(2)