NCT02228538

Brief Summary

The purpose of this study is to obtain patient oriented and clinically oriented physical function outcomes both pre-operatively and post-operatively in patients receiving a total knee arthroplasty.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

October 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 29, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 25, 2023

Status Verified

October 1, 2023

Enrollment Period

1.6 years

First QC Date

June 5, 2014

Last Update Submit

October 23, 2023

Conditions

Osteoarthritis of the Knee

Keywords

total knee arthroplastyosteoarthritis

Outcome Measures

Primary Outcomes (3)

  • Timed Functional Tests at 6 weeks

    Assess patient functional outcomes over time. Comparing times from pre-op to post op of patients performing the same functional tests.

    6 weeks post-op

  • Timed Functional testing at 6 months

    Assess patient functional outcomes over time. Comparing times from pre-op to post op of patients performing the same functional tests.

    6 months post op

  • Timed Functional Testing at 1 year

    Assess patient functional outcomes over time. Comparing times from pre-op to post op of patients performing the same functional tests.

    1 year post-op

Secondary Outcomes (3)

  • Outcome questionnaires at 6 weeks

    6 weeks post-op

  • Outcome questionnaires at 6 months

    6 months post-op

  • Outcome questionnaires at 1 year

    1 year post op

Study Arms (1)

Total knee arthroplasty patients

ConforMIS iTotal (CR) knee implant system and off-the-shelf knee implant systems from various manufacturers

Device: Total knee arthroplasty patients

Interventions

Total knee arthroplasty patientsDEVICE

ConforMIS iTotal (CR) knee implant system \& off-the-shelf standard knee implant system from various manufacturers

Also known as: knee replacement, joint replacement
Total knee arthroplasty patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Total knee arthroplasty patients

You may qualify if:

  • Patient is male or non-pregnant female age 18 years or older at time of study
  • Patient is a candidate for a total knee arthroplasty
  • Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation

You may not qualify if:

  • Patients with a primary diagnosis other than osteoarthritis of the knee as determined by an orthopedic surgeon
  • Patients who have had any previous lower extremity procedure
  • Patients with a BMI greater than or equal to 40
  • Patients with an active infection within the affected knee joint
  • Patients with a neuromuscular or neurosensory deficiency that may limit the ability of the patient to evaluate the safety and efficacy of the device
  • Patients diagnosed with systemic disease or metabolic disorder leading to progressive bone deterioration (e.g. Lupus Erythematosus, Paget's disease)
  • Patients immunologically suppressed or receiving chronic steroids in excess of normal physiological requirements (e.g. greater than 30 days)
  • Patients with a known sensitivity to device materials
  • Non-English speaking patients
  • Patient is a prisoner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Interventions

Arthroplasty, Replacement, KneeArthroplasty, Replacement

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

ArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Deryk Jones, MD

    Ochsner Heath System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2014

First Posted

August 29, 2014

Study Start

October 1, 2013

Primary Completion

May 1, 2015

Study Completion

September 1, 2016

Last Updated

October 25, 2023

Record last verified: 2023-10

Locations

US(1)