Skip to main content
OpenTrials
Completed

NCT Number: NCT04217486

ROM Outcomes in Patients Undergoing a Primary TKA

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

22 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jewish Hospital

Louisville, Kentucky, 40202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  2. Knee Society Score

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

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

  3. 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.

  4. WOMAC Score

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

    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

  5. 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

  6. Active range-of-motion (ROM)

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

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

  7. 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)

  8. 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.

  9. Operative Time

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

    Total Operative Time as defined in minutes

  10. 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.

  11. 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

  1. Number of Participants with postoperative complications

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

    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

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jan 3, 2020
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.