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ROM Outcomes in Patients Undergoing a Primary TKA

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04217486
Enrollment
158
Registered
2020-01-03
Start date
2020-02-04
Completion date
2021-05-31
Last updated
2021-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

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.

Interventions

OTHERPatient 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.

OTHERPatient 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.

Sponsors

University of Louisville
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
22 Years to 89 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Estimated Blood Loss (EBL)outcome measure will be taken at 2 weeks postoperativelyEstimated Blood Loss as defined by the amount of intraoperative blood loss measured in cubic centimeters (cc).
total length of hospital stayoutcome measure will be taken at 2 weeks postoperativelytotal length of hospital stay as defined by number of days from date of surgery to date of discharge
Knee Society Scoreoutcome 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.
WOMAC Scoreoutcome 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
Active range-of-motion (ROM)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)
Incidence of loss of knee motion requiring an MUA (manipulation under anesthesia)outcome measure will be taken 6 weeks (± 2 weeks) postoperativelyLoss 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.
Operative Timeoutcome measure will be taken at 2 weeks postoperativelyTotal Operative Time as defined in minutes
Tourniquet timeoutcome measure will be taken at 2 weeks postoperativelyTotal Tourniquet Time is the number of minutes that the tourniquet is inflated, as defined in minutes.

Secondary

MeasureTime frameDescription
Number of Participants with postoperative complicationsoutcome measure will be taken 6 weeks (± 2 weeks) postoperativelyNumber 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026