NCT02262988

Brief Summary

The purpose of this research study is to evaluate the cause of thigh pain after knee replacement. Different surgical techniques will be used to help determine the cause of thigh pain, and all surgical techniques are accepted and produce good clinical results.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 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

First Submitted

Initial submission to the registry

September 30, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 13, 2014

Completed
2.9 years until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

June 7, 2022

Status Verified

May 1, 2022

Enrollment Period

3.3 years

First QC Date

September 30, 2014

Last Update Submit

June 3, 2022

Conditions

Osteoarthritis, Knee

Keywords

kneejoint replacementtotal knee

Outcome Measures

Primary Outcomes (1)

  • Knee Injury and Osteoarthritis Outcomes Survey (KOOS)

    Survey

    up to 3 months

Secondary Outcomes (4)

  • Pain Scores on Numerical Rating Scale

    up to 3 months

  • Knee swelling

    up to 3 months

  • Knee Range of Motion

    up to 3 months

  • Number of Patients with Adverse Events as a Measure of Safety

    up to 3 months

Study Arms (4)

Tourniquet used with intramedullary rod

EXPERIMENTAL

Patients will undergo a total knee replacement with a tourniquet and intramedullary rod.

Procedure: Total knee replacement

No tourniquet with intramedullary rod

EXPERIMENTAL

Patients will undergo a total knee replacement without a tourniquet and with an intramedullary rod.

Procedure: Total knee replacement

Tourniquet without intramedullary rod

EXPERIMENTAL

Patients will undergo a total knee replacement with a tourniquet and without an intramedullary rod.

Procedure: Total knee replacement

No tourniquet without intramedullary rod

EXPERIMENTAL

Patients will undergo a total knee replacement without a tourniquet nor an intramedullary rod.

Procedure: Total knee replacement

Interventions

Total knee replacementPROCEDURE

Total knee replacement (TKA)

No tourniquet with intramedullary rodNo tourniquet without intramedullary rodTourniquet used with intramedullary rodTourniquet without intramedullary rod

Eligibility Criteria

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

You may qualify if:

  • Subjects undergoing total knee arthroplasty for osteoarthritis
  • Adult patients (age 18 years or older)
  • Written informed consent
  • Ability to speak, read and write English or Spanish

You may not qualify if:

  • Inability to speak, read and write English or Spanish
  • Evidence of malignant disorder/neoplasm in past 60 months
  • Contraindication for removal of infrapatellar fat pad
  • History of smoking and not committed to give up
  • Chronic skin conditions
  • Connective, metabolic or skin disease
  • Evidence of active infection
  • Pregnancy or lactating for female subjects
  • Current corticosteroid use
  • Immunosuppressive medication
  • Renal failure (creatine \> 1.8 mg/dL)
  • Hepatic failure (AST, ALT \> 2x normal values; bilirubin \> 2 mg/dL)
  • Inflammatory joint diseases of the knee that indicate additional, conflating therapies
  • Joint infection within the past 6 months
  • No prisoners or mentally disabled persons
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondren Orthopedic Group, L.L.P.

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Gregory W Stocks, MD

    Fondren Orthopedic Group L.L.P.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2014

First Posted

October 13, 2014

Study Start

September 1, 2017

Primary Completion

December 1, 2020

Study Completion

March 1, 2021

Last Updated

June 7, 2022

Record last verified: 2022-05

Locations

US(1)