NCT04746144

Brief Summary

The ability to resume physical activities, aerobic fitness and a healthy lifestyle without symptoms after total knee arthroplasty (TKA) remains unclear because studies show high rates of patient dissatisfaction. The aim of this study was to evaluate whether an individualized goal-centered rehabilitation protocol leads to high patient-reported physical activities and satisfaction after TKA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

2.5 years

First QC Date

February 2, 2021

Last Update Submit

February 4, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Knee Injury and Osteoarthritis Outcome Joint Replacement Survey (KOOS) Jr 7-item score

    Scored on a scale of 0-100 points, where 0 = total disability and 100 = perfect knee health.

    Preoperative

  • Knee Injury and Osteoarthritis Outcome Joint Replacement Survey (KOOS) Jr 7-item score

    Scored on a scale of 0-100 points, where 0 = total disability and 100 = perfect knee health.

    4 years postoperative

  • Documentation of sports and recreational activities

    Patients provide a list of all sports and recreational activities they participated in after surgery. This is an open-ended question "What sports or recreational activities do you participate in on a regular basis?"

    4 years postoperative

Secondary Outcomes (12)

  • Cincinnati Knee Rating Pain Score

    Preoperative

  • Cincinnati Knee Rating Pain Score

    4 years postoperative

  • Cincinnati Knee Rating Patient Perception of the Overall Knee Condition Score

    Preoperative

  • Cincinnati Knee Rating Patient Perception of the Overall Knee Condition Score

    4 years postoperative

  • Cincinnati Knee Rating Swelling Score

    Preoperative

  • +7 more secondary outcomes

Interventions

Eligibility Criteria

AgeUp to 69 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The patients were selected from the treating surgeon's patient population.

You may qualify if:

  • Age \< 70 years
  • Patient goals to return to recreational and occupational activities
  • Agree to participate in a postoperative rehabilitation and home exercise program

You may not qualify if:

  • Osteoarthritis in other joints
  • Co-morbidities limiting physical activity
  • Presence of a connective tissue disease
  • Autoimmune disease or immune deficiency
  • Age 70 years or more
  • no desire to return to recreational and work activities
  • Refusal to participate in rehabilitation program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Sportsmedicine and Orthopaedic Center

Cincinnati, Ohio, 45242, United States

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Frank R Noyes, MD

    Cincinnati Sportsmedicine and Orthopaedic Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2021

First Posted

February 9, 2021

Study Start

July 1, 2013

Primary Completion

December 31, 2015

Study Completion

January 1, 2021

Last Updated

February 9, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations