Clinical trial NCT04217486: ROM Outcomes in Patients Undergoing a Primary TKA
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2020-01-03
Enrollment: 158
Sex: ALL
Minimum age (years): 22
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: total length of hospital stay
timeFrame: outcome measure will be taken at 2 weeks postoperatively
measure: Knee Society Score
timeFrame: outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery)
measure: Knee Society Score
timeFrame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
measure: WOMAC Score
timeFrame: outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery)
measure: WOMAC Score
timeFrame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
measure: Active range-of-motion (ROM)
timeFrame: outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery)
measure: Active range-of-motion (ROM)
timeFrame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
measure: Incidence of loss of knee motion requiring an MUA (manipulation under anesthesia)
timeFrame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
measure: Operative Time
timeFrame: outcome measure will be taken at 2 weeks postoperatively
measure: Tourniquet time
timeFrame: outcome measure will be taken at 2 weeks postoperatively
measure: Estimated Blood Loss (EBL)
timeFrame: outcome measure will be taken at 2 weeks postoperatively
Secondary outcomes:
measure: Number of Participants with postoperative complications
timeFrame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Jewish Hospital
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Arthur Malkani, MD
role: PRINCIPAL_INVESTIGATOR
References: