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Osteoarthritis (OA) of the KneeNCT07223359

Photographic Evidence on Total Knee Arthroplasty Outcomes

A study testing Photographic Evidence of Postoperative Knee Range of Motion and Standard Postoperative Care in people with Osteoarthritis (OA) of the Knee, run by Loyola University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Historically, total knee arthroplasty (TKA) has been performed to restore knee range of motion and relieve pain, with postoperative rehabilitation focused on helping patients regain mobility and function. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Osteoarthritis (OA) of the Knee
What is being tested?
Photographic Evidence of Postoperative Knee Range of Motion and Standard Postoperative Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
2 sitesUnited States
Study dates
1 Jan 2020to 31 Dec 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged 18 years or older
  • Scheduled to undergo primary unilateral total knee arthroplasty (TKA) at one of the investigators' participating institutions
  • Able to understand study procedures and comply with follow-up requirements
  • Able to read and complete questionnaires in English
  • Willing and able to provide informed consent prior to participation

Who cannot join

  • Undergoing revision TKA
  • History of prior surgery or fracture involving the operative knee
  • Preoperative knee flexion contracture >10 degrees
  • Patients with non-elective or trauma-related indications for knee replacement
  • Inability or unwillingness to provide informed consent

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Gottlieb Memorial Hospital

    Melrose Park, Illinois, 60160

Other trials in United States

About this study

Official title: The Impact of Photographic Evidence on Postoperative Range of Motion Following Total Knee Arthroplasty: A Randomized Control Trial

Historically, total knee arthroplasty (TKA) has been performed to restore knee range of motion and relieve pain, with postoperative rehabilitation focused on helping patients regain mobility and function. This study evaluates whether providing patients with photographic evidence of their knee range of motion immediately after surgery can enhance short-term recovery.

Patients will be randomly assigned to one of two groups: one group will receive printed photographs showing their knee in full flexion immediately after surgery, while the other group will not receive photographs. Outcomes assessed at six weeks postoperatively will include knee range of motion, physical therapy progress metrics, length of hospital stay, and patient-reported outcomes.

Read the detailed description

Participants include patients 18 years or older presenting to the investigators' institutions who are scheduled to undergo a primary total knee arthroplasty (TKA). Exclusion criteria include revision TKA, prior surgery or fracture involving the operative knee, preoperative knee flexion contracture greater than 10 degrees, patients with comorbidities, and those unable or unwilling to provide informed consent.

If, after evaluation, the patient remains eligible, the surgeon will introduce the study. If the patient expresses interest, a member of the study team will approach the patient to explain the study in detail. The voluntary nature of participation will be emphasized, and the prospective participant will be encouraged to ask questions and discuss participation with others. Once all questions have been addressed, the participant will be presented with the informed consent document (ICD). The study team member will step out of the room to allow time for review. If desired, the participant may take a paper copy of the ICD to discuss with family or others before signing. Once all questions have been answered to the participant's satisfaction, the ICD will be signed, preferably in the clinic. If the participant elects to take the ICD home, a follow-up time will be arranged, typically during preoperative clearance or on the day of surgery to review and sign the document.

After informed consent is obtained, preoperative baseline data including range of motion and patient-reported outcome measures will be collected. Participants will then be randomized in a 1:1 fashion to either receive or not receive photographic evidence of their postoperative knee range of motion. Randomization will be performed using stratified randomization lists generated and maintained by the Biostatistics Core at Loyola University Clinical Research Office to ensure equal allocation across sites.

During surgery, photographs of the operated knee in full flexion and full extension will be taken. Participants randomized to the intervention group will receive printed copies of the photographs and instructions to share them with their physical therapist. The control group will not receive any photographs. All participants will receive standard perioperative management, surgical technique, and rehabilitation protocols.

The primary outcome is knee flexion at six weeks postoperatively, measured using a goniometer by a blinded assessor. Secondary outcomes include knee extension, physical therapy progress metrics (total duration of therapy, time to achieve 110 degrees of flexion, and number of therapy sessions), distance walked on postoperative day one, length of hospital stay, and patient-reported outcomes via the Knee Injury and Osteoarthritis Outcome Score (KOOS) survey.

A sample size of 52 patients (26 per group) was calculated to provide 80% power to detect a 10-degree difference in knee flexion at six weeks, assuming a standard deviation of 12 degrees and a two-sided alpha level of 0.05.

Both groups will undergo standard postoperative follow-up at two weeks, six weeks, and as per routine care thereafter. Data collection at each time point will include range of motion assessments, physical therapy metrics, and KOOS surveys.

The investigators hypothesize that providing photographic evidence of postoperative knee range of motion will enhance patient motivation and engagement in rehabilitation, resulting in improved early range of motion and functional recovery compared to standard rehabilitation alone.

Participation in this study carries minimal risk. All procedures, surgical techniques, and follow-up care are consistent with the standard of care for patients undergoing TKA. The primary risk to participants is potential loss of confidentiality, which is rare. There are no additional surgical risks associated with participation. Subject safety will be monitored during routine postoperative visits, and participants will have access to the study team for any questions or concerns.

Being tested
Photographic Evidence of Postoperative Knee Range of Motion, Standard Postoperative Care
Keywords
total knee arthroplasty, range of motion, photographic outcomes
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Photographic Evidence of Postoperative Knee Range of MotionBehavioural

    The intervention consists of providing patients with photographic evidence of their knee range of motion (ROM) immediately following total knee arthroplasty (TKA). After the procedure, while still in the operating room and after sterile dressings are applied, two photographs are taken of the operated knee, one in maximum flexion and one in full extension.

  • Standard Postoperative CareBehavioural

    Participants will receive routine postoperative management and physical therapy following TKA. No photographic evidence of knee range of motion will be provided.

Study groups in NCT07223359
Study groupRoleWhat they receive
Photographic Evidence GroupExperimentalParticipants in this group will receive printed photographs of their operated knee in full flexion and full extension immediately following total knee arthroplasty (TKA). The photographs will be taken in the operating room after dressings are applied. Patients will be instructed to keep one copy for personal use and to provide another copy to their physical therapist. The goal of this intervention is to determine whether visual feedback of postoperative range of motion enhances motivation, engagement in rehabilitation, and early recovery.
Receives: Behavioral: Photographic Evidence of Postoperative Knee Range of Motion
Control GroupActive comparatorParticipants in this group will undergo total knee arthroplasty (TKA) and receive standard postoperative management and rehabilitation without photographs of their knee range of motion. They will participate in the same physical therapy and follow-up schedule as the intervention group.
Receives: Behavioral: Standard Postoperative Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Knee Flexion at Six Weeks Postoperatively

    Knee flexion will be measured in degrees using a goniometer by a blinded assessor at the 6-week postoperative visit. The outcome compares the degree of maximum flexion between participants who received photographic evidence of their postoperative range of motion and those who did not.

    Measured: 6 weeks after total knee arthroplasty

Secondary outcomes (8)
  1. Knee Extension at Six Weeks Postoperatively

    Knee extension will be measured in degrees using a goniometer by a blinded assessor at the 6-week postoperative visit.

    Measured: 6 weeks after total knee arthroplasty

  2. Total Duration of Physical Therapy

    Total duration of physical therapy from initiation to completion, measured in weeks, as documented in the medical record.

    Measured: Up to 6 weeks after surgery

  3. Length of Hospital Stay

    Length of stay (LOS) will be measured as the number of days from the date of surgery to the date of hospital discharge.

    Measured: From the date of surgery until the date of hospital discharge, assessed for up to 6 weeks postoperatively.

  4. Total Number of Physical Therapy Sessions

    Total number of in-person physical therapy sessions completed during the postoperative period, as documented in the medical record.

    Measured: Up to 6 weeks after surgery

  5. Time to Achieve 110° of Knee Flexion (Weeks)

    Number of weeks from surgery until the patient achieves 110° of knee flexion during physical therapy, as documented in the medical record.

    Measured: Up to 6 weeks after surgery

  6. Time to Achieve 110° of Knee Flexion (Sessions)

    Number of physical therapy sessions required for the patient to achieve 110° of knee flexion, as recorded in the physical therapy documentation.

    Measured: Up to 6 weeks after surgery

  7. Distance Walked on Postoperative Day One

    Distance walked during the first postoperative physical therapy session, measured in feet, as documented in the physical therapy record.

    Measured: Postoperative day 1

  8. Patient-Reported Outcome Measures (KOOS Survey)

    Patient-reported outcomes will be measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS) survey, a validated instrument assessing five subscales: Pain, Symptoms, Activities of Daily Living (ADL), Sports and Recreation Function, and Knee-Related Quality of Life (QOL).

    Each subscale is scored from 0 to 100, where 0 represents extreme knee problems and 100 represents no knee problems.

    Measured: 6 weeks after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2025
  2. Study start1 Jan 2020
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2021

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07223359
Sponsor's protocol ID
LU213164
Status last verified
Oct 2025
First submitted
27 Oct 2025
Last updated
31 Oct 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003 Nov 3;1:64. doi: 10.1186/1477-7525-1-64.

    PubMed 14613558
  • Abson S, Kenny B, Rahim R, Benz D, Hellman J. Can visual aides influence rehabilitation and length of stay following knee replacement? A randomized controlled study. Orthop Rev (Pavia). 2015 Mar 31;7(1):5758. doi: 10.4081/or.2015.5758. eCollection 2015 Mar 3.

    PubMed 25874065
  • Pinsornsak P, Kanitnate S, Boontanapibul K. The effect of immediate post-operative knee range of motion photographs on post-operative range of motion after total knee arthroplasty : An assessor-blinded randomized controlled clinical trial in sixty patients. Int Orthop. 2021 Jan;45(1):101-107. doi: 10.1007/s00264-020-04877-3. Epub 2020 Nov 24.

    PubMed 33230607
  • Farahini H, Moghtadaei M, Bagheri A, Akbarian E. Factors influencing range of motion after total knee arthroplasty. Iran Red Crescent Med J. 2012 Jul;14(7):417-21. Epub 2012 Jul 30.

    PubMed 22997557
  • Hyodo K, Masuda T, Aizawa J, Jinno T, Morita S. Hip, knee, and ankle kinematics during activities of daily living: a cross-sectional study. Braz J Phys Ther. 2017 May-Jun;21(3):159-166. doi: 10.1016/j.bjpt.2017.03.012. Epub 2017 Apr 9.

    PubMed 28473283
  • Laubenthal KN, Smidt GL, Kettelkamp DB. A quantitative analysis of knee motion during activities of daily living. Phys Ther. 1972 Jan;52(1):34-43. doi: 10.1093/ptj/52.1.34. No abstract available.

    PubMed 5061683

Questions about this trial

What is this clinical trial studying?

A study testing Photographic Evidence of Postoperative Knee Range of Motion and Standard Postoperative Care in people with Osteoarthritis (OA) of the Knee, run by Loyola University at 2 sites 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 5 inclusion and 5 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 31 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Knee Flexion at Six Weeks Postoperatively (time frame: 6 weeks after total knee arthroplasty). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07223359, which also lists 6 linked publications.

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 31 Oct 2025.

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