Knee OsteoarthritisNCT04217486
ROM Outcomes in Patients Undergoing a Primary TKA
A study testing Patient will be shown a photograph of their knee at 2 weeks postop and Patient will not be shown a photograph of their knee at 2 weeks postop in people with Knee Osteoarthritis, run by University of Louisville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 89 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Patient will be shown a photograph of their knee at 2 weeks postop and Patient will not be shown a photograph of their knee at 2 weeks postop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2020to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Patient will be shown a photograph of their knee at 2 weeks postop, Patient will not be shown a photograph of their knee at 2 weeks postop
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient will be shown a photograph of their knee at 2 weeks postopOther
Patients who undergo primary TKA surgery will then be shown a photograph of their knee at 2 weeks postoperative.
Patient will not be shown a photograph of their knee at 2 weeks postopOther
Patients who undergo primary TKA surgery will not be shown a photograph of their knee at 2 weeks postoperative.
| Study group | Role | What they receive |
|---|---|---|
| A - will be shown their photograph at 2 weeks post-operative. | Experimental | 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. Receives: Other: Patient will be shown a photograph of their knee at 2 weeks postop |
| B - will not be shown their photograph | Active comparator | 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. Receives: Other: Patient will not be shown a photograph of their knee at 2 weeks postop |
What is being measured
The primary outcome is the main question the study is designed to answer.
total length of hospital stay
total length of hospital stay as defined by number of days from date of surgery to date of discharge
Measured: outcome measure will be taken at 2 weeks postoperatively
Knee Society Score
Knee Society Score. The score is on a scale from 0-100. A higher value represents a better outcome.
Measured: outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery)
Knee Society Score
Knee Society Score. The score is on a scale from 0-100. A higher value represents a better outcome.
Measured: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
WOMAC Score
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
Measured: outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery)
WOMAC Score
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
Measured: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Active range-of-motion (ROM)
Active ROM (range-of-motion) as measured by a goniometer (range of 0-135 degrees)
Measured: outcome measure will be taken preoperatively (4-6 weeks prior to date of surgery)
Active range-of-motion (ROM)
Active ROM (range-of-motion) as measured by a goniometer (range of 0-135 degrees)
Measured: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Incidence of loss of knee motion requiring an MUA (manipulation under anesthesia)
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.
Measured: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Operative Time
Total Operative Time as defined in minutes
Measured: outcome measure will be taken at 2 weeks postoperatively
Tourniquet time
Total Tourniquet Time is the number of minutes that the tourniquet is inflated, as defined in minutes.
Measured: outcome measure will be taken at 2 weeks postoperatively
Estimated Blood Loss (EBL)
Estimated Blood Loss as defined by the amount of intraoperative blood loss measured in cubic centimeters (cc).
Measured: outcome measure will be taken at 2 weeks postoperatively
Secondary outcomes (1)
Number of Participants with postoperative complications
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
Measured: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start4 Feb 2020
- Primary completion21 Sep 2020
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arthur Malkani, University of Louisville
- Investigators
- Arthur Malkani, MD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04217486
- Sponsor's protocol ID
- 19.1179
- Status last verified
- Sep 2021
- First submitted
- 30 Dec 2019
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04217486
- Acronym / sponsor ID
- 19.1179
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 21 Sep 2020 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 3 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A - will be shown their photograph at 2 weeks post-operative. | Experimental | Other: Patient will be shown a photograph of their knee at 2 weeks postop40-50 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. |
| B - will not be shown their photograph | Active comparator | Other: Patient will not be shown a photograph of their knee at 2 weeks postop40-50 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. |
Who may qualify
- Ages
- 22 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient will be shown a photograph of their knee at 2 weeks postopPatients who undergo primary TKA surgery will then be shown a photograph of their knee at 2 weeks postoperative. | Other | A - will be shown their photograph at 2 weeks post-operative. |
| Patient will not be shown a photograph of their knee at 2 weeks postopPatients who undergo primary TKA surgery will not be shown a photograph of their knee at 2 weeks postoperative. | Other | B - will not be shown their photograph |
Primary outcome
total length of hospital stay
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: outcome measure will be taken at 2 weeks postoperatively
Total Operative Time as defined in minutes
Tourniquet time
Time frame: 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)
Time frame: 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).
1 secondary outcome
Number of Participants with postoperative complications
Time frame: outcome measure will be taken 6 weeks (± 2 weeks) postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arthur Malkani, MD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient will be shown a photograph of their knee at 2 weeks postop and Patient will not be shown a photograph of their knee at 2 weeks postop in people with Knee Osteoarthritis, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total length of hospital stay (time frame: outcome measure will be taken at 2 weeks postoperatively). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021; AzTrials last refreshed its copy on 31 Oct 2026.