ROM Outcomes in Patients Undergoing a Primary TKA

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Other: Patient will not be shown a photograph of their knee at 2 weeks postop; Other: Patient will be shown a photograph of their knee at 2 weeks postop

• Registration Number: NCT04217486
• Lead Sponsor: University of Louisville

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.

Study Timeline

• Study First Submitted: 2019-12-30
• Study First Submitted QC: 2019-12-30
• Study First Posted: 2020-01-03
• Study Start: 2020-02-04
• Primary Completion: 2020-09-21
• Study Completion: 2021-05-31
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-14
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B - will not be shown their photograph	Patient will not be shown a photograph of their knee at 2 weeks postop	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.
A - will be shown their photograph at 2 weeks post-operative.	Patient will be shown a photograph of their knee at 2 weeks postop	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.

Primary Outcome Measures

Name	Time	Method
Knee Society Score	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	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)	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)
Operative Time	outcome measure will be taken at 2 weeks postoperatively	Total Operative Time as defined in minutes
total length of hospital stay	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
Tourniquet time	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)	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)	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 Outcome Measures

Name	Time	Method
Number of Participants with postoperative complications	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

Trial Locations

Locations (1)

Jewish Hospital; 🇺🇸 Louisville, Kentucky, United States