Recruiting

Observational Study

Sponsor:

DC2 Healthcare

Code:

NCT02188199

Conditions

Knee Replacement

Hip Replacement

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Conditions

Knee Replacement

Hip Replacement

Study ID

NCT02188199

Start date

May, 2012

Status verified date

Jul, 2014

Primary completion date

Dec, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Design

Enrollment

10000 participants

Anticipated

Interventions and Outcome Measures

Arms

Knee Replacement

Patients undergoing knee replacement surgery

Hip Replacement

Patients undergoing hip replacement

Primary outcome measure

  • Change in Hip disability and Osteoarthritis Outcome Score (HOOS) from baseline at 3 months [ Time Frame: baseline and 3 months ]
  • Change in Hip disability and Osteoarthritis Outcome Score (HOOS) from baseline at 6 months [ Time Frame: baseline and 6 months ]
  • Change in Hip disability and Osteoarthritis Outcome Score (HOOS) from baseline at 1 year [ Time Frame: baseline and 1 year ]
  • Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline at 3 months [ Time Frame: baseline and 3 months ]
  • Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline at 1 year [ Time Frame: baseline and 1 year ]
  • Change in Knee injury and Osteoarthritis Outcome Score (KOOS) from baseline at 6 months [ Time Frame: baseline and 6 months ]

Central Contacts and Locations

Central contacts

Christina R Cook, PhD

615-712-9574ccook@dc2healthcare.com

Risa Tyo, PharmD

615-712-9574rtyo@dc2healthcare.com

Locations

DC2 Healthcare

Recruiting

Nashville, Tennessee, United States, 37211

Contacts

Christina R Cook, PhD

615-712-9574ccook@dc2healthcare.com

Risa Tyo, PharmD

615-712-9574rtyo@dc2healthcare.com

More Information

Sponsor

DC2 Healthcare

Last update posted

Jul 11, 2014

Last verified

Jul, 2014

Keywords

  • Hip
  • Knee
  • Hip replacement
  • Knee replacement
  • Total Joint

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by DC2 Healthcare on 2014-07-11.