ROM Outcomes in Patients Undergoing a Primary TKA

Knee Osteoarthritis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04217486
• Other study ID #: 19.1179
• Status: Completed
• Phase: N/A
• Start date: February 4, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: September 2021
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: May 31, 2021
• Est. primary completion date: September 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
United States	Jewish Hospital	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	Operative Time	Total Operative Time as defined in minutes	outcome measure will be taken at 2 weeks postoperatively
Primary	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
Primary	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	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	outcome measure will be taken 6 weeks (± 2 weeks) postoperatively