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Clinical Trials/NCT04217486
NCT04217486
Completed
Not Applicable

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.

University of Louisville1 site in 1 country158 target enrollmentFebruary 4, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
University of Louisville
Enrollment
158
Locations
1
Primary Endpoint
Knee Society Score
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 4, 2020
End Date
May 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Arthur Malkani

Professor, Adult Reconstruction, Dept. of Orthopaedic Surgery

University of Louisville

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

Outcomes

Primary Outcomes

Knee Society Score

Time Frame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively

Knee Society Score. The score is on a scale from 0-100. A higher value represents a better outcome.

WOMAC Score

Time Frame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively

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)

Time Frame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively

Active ROM (range-of-motion) as measured by a goniometer (range of 0-135 degrees)

total length of hospital stay

Time Frame: outcome measure will be taken at 2 weeks postoperatively

total length of hospital stay as defined by number of days from date of surgery to date of discharge

Operative Time

Time Frame: outcome measure will be taken at 2 weeks postoperatively

Total Operative Time as defined in minutes

Tourniquet time

Time Frame: outcome measure will be taken at 2 weeks postoperatively

Total Tourniquet Time is the number of minutes that the tourniquet is inflated, as defined in minutes.

Incidence of loss of knee motion requiring an MUA (manipulation under anesthesia)

Time Frame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively

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.

Estimated Blood Loss (EBL)

Time Frame: outcome measure will be taken at 2 weeks postoperatively

Estimated Blood Loss as defined by the amount of intraoperative blood loss measured in cubic centimeters (cc).

Secondary Outcomes

  • Number of Participants with postoperative complications(outcome measure will be taken 6 weeks (± 2 weeks) postoperatively)

Study Sites (1)

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