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ROM Outcomes in Patients Undergoing a Primary TKA

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient will be shown a photograph of their knee at 2 weeks postop
Patient will not be shown a photograph of their knee at 2 weeks postop
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Knee Osteoarthritis

Eligibility Criteria

22 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient is between the age of 22-89
  2. Patient is scheduled to undergo a unilateral, cementless primary TKA, secondary to osteoarthritis
  3. Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization documents
  4. Patient is able to read and speak English.

Exclusion Criteria:

  1. Patient is under the age of 22 or over the age of 89
  2. Patient has preoperative stiffness/contracture of the knee secondary to post-traumatic arthritis
  3. Patient is scheduled to undergo a bilateral TKA surgery
  4. Patient is unable to read and speak English

Sites / Locations

  • Jewish Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A - will be shown their photograph at 2 weeks post-operative.

B - will not be shown their photograph

Arm Description

40-50 arms: patients undergoing a unilateral, cementless primary TKA, secondary to osteoarthritis will be shown a photograph of their knee, photographed in maximum flexion and extension, at 2 weeks postoperatively.

40-50 arms: patients undergoing a unilateral, cementless primary TKA, secondary to osteoarthritis will not be shown a photograph of their knee, photographed in maximum flexion and extension, at 2 weeks postoperatively.

Outcomes

Primary Outcome Measures

total length of hospital stay
total length of hospital stay as defined by number of days from date of surgery to date of discharge
Knee Society Score
Knee Society Score. The score is on a scale from 0-100. A higher value represents a better outcome.
Knee Society Score
Knee Society Score. The score is on a scale from 0-100. A higher value represents a better outcome.
WOMAC Score
WOMAC score. The score is on a scale from 0-100. In contrast to the Knee Society Score, on the WOMAC a lower value represents a better outcome
WOMAC Score
WOMAC score. The score is on a scale from 0-100. In contrast to the Knee Society Score, on the WOMAC a lower value represents a better outcome
Active range-of-motion (ROM)
Active ROM (range-of-motion) as measured by a goniometer (range of 0-135 degrees)
Active range-of-motion (ROM)
Active ROM (range-of-motion) as measured by a goniometer (range of 0-135 degrees)
Incidence of loss of knee motion requiring an MUA (manipulation under anesthesia)
Loss of knee motion is defined as failure to achieve greater than 100 degrees of active flexion. Manipulation under anesthesia is an outpatient procedure performed by orthopedic surgeon to help improve patient's range-of-motion.
Operative Time
Total Operative Time as defined in minutes
Tourniquet time
Total Tourniquet Time is the number of minutes that the tourniquet is inflated, as defined in minutes.
Estimated Blood Loss (EBL)
Estimated Blood Loss as defined by the amount of intraoperative blood loss measured in cubic centimeters (cc).

Secondary Outcome Measures

Number of Participants with postoperative complications
Number of Participants with postoperative complications. A postoperative complication is defined as any diagnosis or condition that necessitates a re-operation or procedure on the surgical knee

Full Information

First Posted
December 30, 2019
Last Updated
September 14, 2021
Sponsor
University of Louisville
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1. Study Identification

Unique Protocol Identification Number
NCT04217486
Brief Title
ROM Outcomes in Patients Undergoing a Primary TKA
Official Title
Will Visual Affirmation of Knee Range of Motion (ROM) Affect Patient Outcomes in Patients Undergoing a Primary Total Knee Arthroplasty (TKA)? A Prospective, Randomized Study.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 4, 2020 (Actual)
Primary Completion Date
September 21, 2020 (Actual)
Study Completion Date
May 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this prospective, randomized study is to compare the outcomes of patients undergoing primary TKA after photographing final knee range of motion immediately post-operatively and sharing these photographs with patients at their first follow-up appointment versus a group that does not see a photograph.
Detailed Description
The goal of this prospective, randomized study is to compare the outcomes of patients undergoing primary total knee arthroplasty (TKA) after photographing final knee range of motion immediately postoperatively and sharing these photographs with patients at their first follow-up appointment versus a group that does not see a photograph. The knee will be photographed in maximum flexion and extension. The primary objectives will be to compare the range of motion of the operative knee at 2 weeks and 6 weeks postoperatively. In the investigator's institution, patients who have failed to achieve 90 degrees of flexion at a postoperative period of 6 weeks undergo manipulation of the knee under anesthesia (MUA). The investigators will also measure how many patients require MUA in the photograph group and non-photograph group. MUA will be performed if patients fail to achieve 90 degrees of flexion at 6 weeks post-op.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A - will be shown their photograph at 2 weeks post-operative.
Arm Type
Experimental
Arm Description
40-50 arms: patients undergoing a unilateral, cementless primary TKA, secondary to osteoarthritis will be shown a photograph of their knee, photographed in maximum flexion and extension, at 2 weeks postoperatively.
Arm Title
B - will not be shown their photograph
Arm Type
Active Comparator
Arm Description
40-50 arms: patients undergoing a unilateral, cementless primary TKA, secondary to osteoarthritis will not be shown a photograph of their knee, photographed in maximum flexion and extension, at 2 weeks postoperatively.
Intervention Type
Other
Intervention Name(s)
Patient will be shown a photograph of their knee at 2 weeks postop
Intervention Description
Patients who undergo primary TKA surgery will then be shown a photograph of their knee at 2 weeks postoperative.
Intervention Type
Other
Intervention Name(s)
Patient will not be shown a photograph of their knee at 2 weeks postop
Intervention Description
Patients who undergo primary TKA surgery will not be shown a photograph of their knee at 2 weeks postoperative.
Primary Outcome Measure Information:
Title
total length of hospital stay
Description
total length of hospital stay as defined by number of days from date of surgery to date of discharge
Time Frame
outcome measure will be taken at 2 weeks postoperatively
Title
Knee Society Score
Description
Knee Society Score. The score is on a scale from 0-100. A higher value represents a better outcome.
Time Frame
outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery)
Title
Knee Society Score
Description
Knee Society Score. The score is on a scale from 0-100. A higher value represents a better outcome.
Time Frame
outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Title
WOMAC Score
Description
WOMAC score. The score is on a scale from 0-100. In contrast to the Knee Society Score, on the WOMAC a lower value represents a better outcome
Time Frame
outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery)
Title
WOMAC Score
Description
WOMAC score. The score is on a scale from 0-100. In contrast to the Knee Society Score, on the WOMAC a lower value represents a better outcome
Time Frame
outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Title
Active range-of-motion (ROM)
Description
Active ROM (range-of-motion) as measured by a goniometer (range of 0-135 degrees)
Time Frame
outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery)
Title
Active range-of-motion (ROM)
Description
Active ROM (range-of-motion) as measured by a goniometer (range of 0-135 degrees)
Time Frame
outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Title
Incidence of loss of knee motion requiring an MUA (manipulation under anesthesia)
Description
Loss of knee motion is defined as failure to achieve greater than 100 degrees of active flexion. Manipulation under anesthesia is an outpatient procedure performed by orthopedic surgeon to help improve patient's range-of-motion.
Time Frame
outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Title
Operative Time
Description
Total Operative Time as defined in minutes
Time Frame
outcome measure will be taken at 2 weeks postoperatively
Title
Tourniquet time
Description
Total Tourniquet Time is the number of minutes that the tourniquet is inflated, as defined in minutes.
Time Frame
outcome measure will be taken at 2 weeks postoperatively
Title
Estimated Blood Loss (EBL)
Description
Estimated Blood Loss as defined by the amount of intraoperative blood loss measured in cubic centimeters (cc).
Time Frame
outcome measure will be taken at 2 weeks postoperatively
Secondary Outcome Measure Information:
Title
Number of Participants with postoperative complications
Description
Number of Participants with postoperative complications. A postoperative complication is defined as any diagnosis or condition that necessitates a re-operation or procedure on the surgical knee
Time Frame
outcome measure will be taken 6 weeks (± 2 weeks) postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is between the age of 22-89 Patient is scheduled to undergo a unilateral, cementless primary TKA, secondary to osteoarthritis Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization documents Patient is able to read and speak English. Exclusion Criteria: Patient is under the age of 22 or over the age of 89 Patient has preoperative stiffness/contracture of the knee secondary to post-traumatic arthritis Patient is scheduled to undergo a bilateral TKA surgery Patient is unable to read and speak English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthur Malkani, MD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jewish Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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ROM Outcomes in Patients Undergoing a Primary TKA

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