ROM Outcomes in Patients Undergoing a Primary TKA

NCT04217486 | Completed

• 1 other identifier: 19.1179
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (11)

• total length of hospital stay

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

  outcome measure will be taken at 2 weeks postoperatively

• Knee Society Score

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

  outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery)

• Knee Society Score

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

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

• 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

  outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery)

• 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

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

• Active range-of-motion (ROM)

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

  outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery)

• Active range-of-motion (ROM)

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

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

• 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.

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

• Operative Time

  Total Operative Time as defined in minutes

  outcome measure will be taken at 2 weeks postoperatively

• Tourniquet time

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

  outcome measure will be taken at 2 weeks postoperatively

• Estimated Blood Loss (EBL)

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

  outcome measure will be taken at 2 weeks postoperatively

Secondary Outcomes (1)

• Number of Participants with postoperative complications

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

Study Arms (2)

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

EXPERIMENTAL

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.

Other: Patient will be shown a photograph of their knee at 2 weeks postop

B - will not be shown their photograph

ACTIVE COMPARATOR

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.

Other: Patient will not be shown a photograph of their knee at 2 weeks postop

Interventions

Patient will be shown a photograph of their knee at 2 weeks postop OTHER

Patients who undergo primary TKA surgery will then be shown a photograph of their knee at 2 weeks postoperative.

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

Patient will not be shown a photograph of their knee at 2 weeks postop OTHER

Patients who undergo primary TKA surgery will not be shown a photograph of their knee at 2 weeks postoperative.

B - will not be shown their photograph

Eligibility Criteria

• Age: 22 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

Jewish Hospital

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Postoperative Period

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Perioperative Period; Surgical Procedures, Operative; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Arthur Malkani, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Adult Reconstruction, Dept. of Orthopaedic Surgery

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 3, 2020
• Study Start: February 4, 2020
• Primary Completion: September 21, 2020
• Study Completion: May 31, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)