ROM Outcomes in Patients Undergoing a Primary TKA

NCT ID: NCT04217486

Last Updated: 2021-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-04

Study Completion Date

2021-05-31

Brief Summary

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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

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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.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type OTHER

Patients who undergo primary TKA surgery will then be shown a photograph of their knee at 2 weeks postoperative.

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

Patients who undergo primary TKA surgery will not be shown a photograph of their knee at 2 weeks postoperative.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Louisville

OTHER

Sponsor Role lead

Responsible Party

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Arthur Malkani

Professor, Adult Reconstruction, Dept. of Orthopaedic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arthur Malkani, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

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Jewish Hospital

Louisville, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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19.1179

Identifier Type: -

Identifier Source: org_study_id

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