NCT02907047

Brief Summary

The purpose of this study is to correlate functional outcomes and perioperative complications with tourniquet use during total knee arthroplasty.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jun 2016

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

June 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

July 1, 2019

Status Verified

June 1, 2019

Enrollment Period

10 months

First QC Date

September 15, 2016

Last Update Submit

June 27, 2019

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (3)

  • timed up and go (TUG) score

    4 weeks following surgery

  • Stair Climb test

    time, in seconds, to climb one flight of nine stairs

    in hospital (usually less than 2 days), 4 weeks post-op, 6 months post-op

  • Visual Analog Scale: Pain

    in hospital (usually less than 2 days), 4 weeks post-op, 6 months post-op

Secondary Outcomes (3)

  • blood loss

    intra-operative

  • surgical field visualization

    intra-operative

  • range of motion

    in hospital (usually less than 2 days), 4 weeks post-op, 6 months post-op

Study Arms (2)

Tourniquet

ACTIVE COMPARATOR

These subjects will have their tourniquet inflated during key portions of the total knee arthroplasty procedure

Other: tourniquet inflated

No tourniquet

OTHER

These subjects will not have their tourniquet inflated during key portions of the total knee arthroplasty procedure

Other: tourniquet not inflated

Interventions

tourniquet inflatedOTHER
Tourniquet
tourniquet not inflatedOTHER
No tourniquet

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of osteoarthritis

You may not qualify if:

  • Revision surgery
  • Bilateral knee surgery
  • Age \<18 or \>80
  • BMI \>40
  • Baseline lower extremity strength less than 5/5
  • Vascular calcifications
  • History of chronic narcotic use, defined as more than 5mg of oxycodone q4 hours
  • Functionally limiting spine disease
  • Other functionally limiting lower extremity disorder (i.e. symptomatic ipsilateral hip disease)
  • Patients who cannot perform the baseline functional tests
  • Allergy/contraindication to protocol medications
  • Post-traumatic arthritis
  • Inflammatory arthritis
  • Pregnancy
  • Prisoners
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rothman Institute

Philadelphia, Pennsylvania, 19148, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2016

First Posted

September 20, 2016

Study Start

June 1, 2016

Primary Completion

April 1, 2017

Study Completion

October 1, 2017

Last Updated

July 1, 2019

Record last verified: 2019-06

Locations

US(1)