ROM Outcomes in Patients Undergoing a Primary TKA
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: A - will be shown their photograph at 2 weeks post-operative. 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
Patients who undergo primary TKA surgery will then be shown a photograph of their knee at 2 weeks postoperative.
|
| Active Comparator: B - will not be shown their photograph 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
Patients who undergo primary TKA surgery will not be shown a photograph of their knee at 2 weeks postoperative.
|
Outcome Measures
Primary Outcome Measures
- 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
- Knee Society Score [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.
- 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 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
- 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 preoperatively (4-6 weeks prior to date of surgery)]
Active ROM (range-of-motion) as measured by a goniometer (range of 0-135 degrees)
- 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)
- 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.
- Operative Time [outcome measure will be taken at 2 weeks postoperatively]
Total Operative Time as defined in minutes
- 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.
- 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
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jewish Hospital | Louisville | Kentucky | United States | 40202 |
Sponsors and Collaborators
- University of Louisville
Investigators
- Principal Investigator: Arthur Malkani, MD, University of Louisville
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19.1179