NCT02740738

Brief Summary

To investigate the association between grip strength and preoperative pain threshold as measured by pressure algometer and validated pain outcome surveys.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
201

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

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

March 1, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 15, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2018

Completed
Last Updated

April 8, 2019

Status Verified

April 1, 2019

Enrollment Period

2.3 years

First QC Date

March 16, 2016

Last Update Submit

April 4, 2019

Conditions

Knee ArthritisHip Arthritis

Keywords

Knee ArthroplastyHip Arthroplasty

Outcome Measures

Primary Outcomes (4)

  • Inpatient length of stay in days

    amount of time in hospital

    1-3 on days average

  • pain control average visual analogue scale 1 - 10 of hospital stay

    averaging the subjective pain control

    1-3 days on average

  • physical therapy performance on the first day after surgery

    distance walked in feet on post op day 1

    post op day 1

  • discharge location placement

    home, rehab or nursing facility

    1 - 3 days on average

Secondary Outcomes (3)

  • Outpatient narcotic pill consumption

    6-week from surgery

  • Outpatient narcotic consumption refill needed

    6-week from surgery

  • Outpatient narcotic consumption multiple refills needed

    6-week from surgery

Other Outcomes (2)

  • Complications short term after surgery

    6-week from surgery

  • Complications long term after surgery

    surgery to 1yr postoperative

Interventions

Wagner Pain AlgometerDEVICE

applied at a 90 degree angle to the skin at a constant rate of 10kPa/s to minimize the impact of the examiner's reaction time on recorded pain thresholds

DynamometerDEVICE

Dominant Hand Grip strength measured by the average of 3 attempts

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • any participant undergoing elective primary total knee arthroplasty or total hip arthroplasty
  • Participants of the following investigators will be approached: Bolognesi, Wellman, Attarian, and Seyler

You may not qualify if:

  • previous hip or knee surgery in the operative joint

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Medical Plaza Page Road

Durham, North Carolina, 27703, United States

Location

MeSH Terms

Interventions

Muscle Strength Dynamometer

Intervention Hierarchy (Ancestors)

Diagnostic EquipmentEquipment and Supplies

Study Officials

  • Samuel Wellman, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2016

First Posted

April 15, 2016

Study Start

March 1, 2016

Primary Completion

June 30, 2018

Study Completion

August 6, 2018

Last Updated

April 8, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)