ROM Outcomes in Patients Undergoing a Primary TKA

University of Louisville (UOFL)

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT04217486

19.1179

Details and patient eligibility

About

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.

Full 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.

Enrollment: 158 patients

Sex: All

Ages: 22 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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158 participants in 2 patient groups

A - will be shown their photograph at 2 weeks post-operative.

Experimental group

Description:

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.

Treatment:

Other: Patient will be shown a photograph of their knee at 2 weeks postop

B - will not be shown their photograph

Active Comparator group

Description:

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.

Treatment:

Other: Patient will not be shown a photograph of their knee at 2 weeks postop