Recruiting

Observational Study

Sponsor:

Cincinnati Sportsmedicine Research and Education Foundation

Code:

NCT03039907

Conditions

Arthroplasty, Replacement, Knee

Eligibility Criteria

Sex: All

Age: 20 - 65

Healthy Volunteers: Not accepted

Interventions

Total Knee Arthroplasty

Study Details

Brief summary:

The main purpose of this study is to examine the factors that allow patients that undergo total knee arthroplasty to return to recreational sports and/or work activities, and to achieve recommended physical activity levels.

Conditions

Arthroplasty, Replacement, Knee

Study ID

NCT03039907

Start date

Jan 23, 2017

Status verified date

Oct, 2020

Completion date

Jul 1, 2022

Anticipated

Primary completion date

Apr 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Men or women 65 years of age or younger.
  • Patient indicates before surgery the desire to return to recreational (sports) and/or work activities postoperatively
  • Patient provides informed consent.
  • Patient complies with postoperative rehabilitation program.

Exclusion Criteria:

  • Patient did not desire to return to recreational and/or work activities after TKA
  • History of alcohol or drug abuse within 3 years of the operation.
  • Disabling or widespread osteoarthritis or other joint disease in any other joint.
  • Presence of a significant connective tissue disease, autoimmune disease, HIV-positive, or immune deficiency syndrome.
  • Any other contraindications that in the opinion of the principal investigator would interfere with the conduct of the study.

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Interventions

Total Knee Arthroplasty

Total knee arthroplasty

Primary outcome measure

  • Analysis of Number of Participants That Return to Recreational and Fitness Activities [ Time Frame: 2 years postoperatively ]

Central Contacts and Locations

Central contacts

Frank R Noyes, MD

513-347-9999frnoyes@gmaili.com

Cassie Fleckenstein, MS

513-792-3232cfleckenstein@csmref.org

Locations

Cincinnati Sportsmedicine and Orthopaedic Center

Recruiting

Cincinnati, Ohio, United States, 45242

Contacts

Cassie Fleckenstein, M.S.

513-794-8466cfleckenstein@csmref.org

Principal Investigator:

Frank Noyes, M.D.

More Information

Sponsor

Cincinnati Sportsmedicine Research and Education Foundation

Last update posted

Oct 8, 2020

Last verified

Oct, 2020

Keywords

  • Knee
  • Replacement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cincinnati Sportsmedicine Research and Education Foundation on 2020-10-08.