Return to Physical Activities After Total Knee Arthroplasty

NCT03039907 | Unknown DMC

• 1 other identifier: TKAUnder65-001
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

Knee; Replacement

Outcome Measures

Primary Outcomes (1)

• Analysis of Number of Participants That Return to Recreational and Fitness Activities

  Participants will complete a questionnaire that determines the type of physical activities they routinely participate in (for instance, swimming, bicycling, hiking, golf). Patients will also complete two questions regarding their general fitness level in accordance with current standards of the American Heart Association. These questions are contained in the study patient registry.

  2 years postoperatively

Secondary Outcomes (3)

• Assessment of Effect of Charlson Comorbidity Index on Return to Recreational and Physical Activities

  2 years postoperatively

• Assessment of Postoperative Complications on Return to Recreational and Physical Activities

  2 years postoperatively

• Assessment of Effect of Preoperative Body Mass Index on Return to Recreational and Physical Activities

  2 years postoperatively

Interventions

Total Knee Arthroplasty PROCEDURE

Total knee arthroplasty

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients 65 years of age and younger who undergo total knee arthroplasty who desire to return to recreational (sports) and/or work activities postoperatively.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cincinnati Sportsmedicine Research and Education Foundation: lead

Study Sites (1)

Cincinnati Sportsmedicine and Orthopaedic Center

Cincinnati, Ohio, 45242, United States

RECRUITING

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Frank R Noyes, MD

  Cincinnati Sportsmedicine and Orthopaedic Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frank R Noyes, MD

CONTACT

513-347-9999; frnoyes@gmaili.com

Cassie Fleckenstein, MS

CONTACT

513-792-3232; cfleckenstein@csmref.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Clinical Studies

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: February 1, 2017
• Study Start: January 23, 2017
• Primary Completion: April 1, 2022
• Study Completion: July 1, 2022
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)