NCT03933969

Brief Summary

Researchers are trying to assess a predictive value or correlation of outcome measures results on subjects following a total knee or total hip arthroplasty in order to better predict the time frame taken to achieve certain functional milestones that are pertinent to subject population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2019

Typical duration 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

First Submitted

Initial submission to the registry

April 30, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 1, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

June 11, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2022

Completed
Last Updated

January 17, 2023

Status Verified

January 1, 2023

Enrollment Period

3.5 years

First QC Date

April 30, 2019

Last Update Submit

January 13, 2023

Conditions

Joint ArthroplastyKnee and Hip

Outcome Measures

Primary Outcomes (1)

  • Assistive Device Weaning

    Number of days to weaning from all assistive devices

    Approximately 3 months

Secondary Outcomes (1)

  • Weaning from pain medication, ability to reciprocally use steps, ability to walk 1 mile or 30 minutes consecutively

    Approximately 3-6 months

Eligibility Criteria

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

Subjects status post total hip and total knee arthroplasty that will undergo standard inpatient and outpatient physical therapy evaluation following total joint surgery.

You may qualify if:

  • Patient's 18 years or older
  • Patients who recently underwent a primary total hip or total knee arthroplasty
  • Patient who recently underwent a total hip or total knee revision

You may not qualify if:

  • Patients who lack the ability to provide informed consent
  • Patients with previous total joint replacement within the last 6 months
  • Patients with complications following surgery such as DVT/PE/Infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

Study Officials

  • Ryan C McCoy, PT, DPT, OCS

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 30, 2019

First Posted

May 1, 2019

Study Start

June 11, 2019

Primary Completion

December 23, 2022

Study Completion

December 23, 2022

Last Updated

January 17, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)