NCT02188199

Brief Summary

This study will assess the efficacy of products, implants, and procedures for knee and hip replacement.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
10,000

participants targeted

Target at 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

May 1, 2012

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 11, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

July 11, 2014

Status Verified

July 1, 2014

Enrollment Period

4.6 years

First QC Date

July 10, 2014

Last Update Submit

July 10, 2014

Conditions

Knee ReplacementHip Replacement

Keywords

HipKneeHip replacementKnee replacementTotal Joint

Outcome Measures

Primary Outcomes (6)

  • Change in Hip disability and Osteoarthritis Outcome Score (HOOS) from baseline at 3 months

    Assessment of hip symptoms and disability to be taken at baseline and 3 months after surgery

    baseline and 3 months

  • Change in Hip disability and Osteoarthritis Outcome Score (HOOS) from baseline at 6 months

    Assessment of hip symptoms and disability to be taken at baseline and 6 months after surgery

    baseline and 6 months

  • Change in Hip disability and Osteoarthritis Outcome Score (HOOS) from baseline at 1 year

    Assessment of hip symptoms and disability to be taken at baseline and 1 year after surgery

    baseline and 1 year

  • Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline at 3 months

    Assessment of knee symptoms and disability to be taken at baseline and 3 months after surgery

    baseline and 3 months

  • Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline at 1 year

    Assessment of knee symptoms and disability to be taken at baseline and 1 year after surgery

    baseline and 1 year

  • Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline at 6 months

    Assessment of knee symptoms and disability to be taken at baseline and 6 months after surgery

    baseline and 6 months

Secondary Outcomes (5)

  • Adverse Events at time of surgery

    Time of surgery

  • Adverse Events at 6 weeks after surgery

    6 weeks after surgery

  • Adverse Events at 3 months after surgery

    3 months after surgery

  • Adverse Events at 6 months after surgery

    6 months after surgery

  • Adverse Events at 1 year after surgery

    1 year after surgery

Study Arms (2)

Knee Replacement

Patients undergoing knee replacement surgery

Hip Replacement

Patients undergoing hip replacement

Eligibility Criteria

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

The study population will come from cohorts of patients undergoing either knee or hip replacement in accordance with a nationwide multicenter observational study design. Eligibility criteria require only that patients are undergoing knee or hip replacement, are able to sign informed consent and are 18 years of age or older. Approximately 10,000 patients will be enrolled

You may qualify if:

  • At least 18 years of age
  • Undergoing knee or hip replacement
  • Subject is likely to follow standard of care post-operative follow up for at least 1 year

You may not qualify if:

  • Inability to complete follow-up visits or required questionnaires
  • Inability to provide informed consent without a legally authorized representative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DC2 Healthcare

Nashville, Tennessee, 37211, United States

RECRUITING

Related Links

Central Study Contacts

Christina R Cook, PhD

CONTACT

615-712-9574ccook@dc2healthcare.com

Risa Tyo, PharmD

CONTACT

615-712-9574rtyo@dc2healthcare.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2014

First Posted

July 11, 2014

Study Start

May 1, 2012

Primary Completion

December 1, 2016

Last Updated

July 11, 2014

Record last verified: 2014-07

Locations

US(1)