ACLNCT05878652
Playmaker 3D Printed Knee Extender
A study testing 3D printed knee extender device and Standard Prehabilitation Education in people with ACL and ACL Injury, run by Sanford Health at 2 sites in United States.
Trial summary
The purpose of this study is to explore the development of, and patient outcomes associated with, the use of individually printed knee extender in conjunction with a video-based home pre-habilitation program for patients who have suffered an ACL rupture before surgery. Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- ACL, ACL Injury
- What is being tested?
- 3D printed knee extender device and Standard Prehabilitation Education
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jun 2022to 31 Dec 2023
- 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 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 14-60 years old patients who have suffered an isolated primary ACL rupture
Who cannot join
- Patients who have already attained full knee extension
- Open skin wounds that would come into contact with the device
- Pregnant women
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sanford Orthopedics and Sports Medicine
Fargo, North Dakota, 58103
Sanford Orthopedics and Sports Medicine
Sioux Falls, South Dakota, 57104
About this study
Official title: Utilization of a 3D Printed Customized Knee Extender on Patient Outcomes Following ACL Injuries
The purpose of this study is to explore the development of, and patient outcomes associated with, the use of individually printed knee extender in conjunction with a video-based home pre-habilitation program for patients who have suffered an ACL rupture before surgery.
Read the detailed description
The proposed study will assess the efficacy of utilizing desktop 3DP for patient-specific knee extenders paired with a video-based home pre-habilitation program to address the aforementioned barriers. If the novel device and home program is found to be a viable treatment option, this may improve or replace current treatments for knee pre-habilitation, increase accessibility to proper treatment, and reduce cost and time burden on patients, PTs, and providers. The study will offer a greater understanding of potential improvements to clinical workflows and efficiencies through using 3DP. This technology is an under- utilized resource; further research into the applications of 3DP in the field of orthopaedics will provide opportunities to improve patient care and outcomes.
- Conditions
- ACL, ACL Injury
- Being tested
- 3D printed knee extender device, Standard Prehabilitation Education
- Keywords
- Desktop 3D Printing, Knee Extender, Pre-habilitation
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed knee extender deviceDevice
Participants will receive the standard of prehabilitation education at Sanford as well as a 3D printed knee extension device with sealed water bottles and a home prehabilitation program designed to be used with the 3D printed knee extension device.
Standard Prehabilitation EducationOther
Participants in the control group will receive the standard prehabilitation education at Sanford and provided exercises to do at home.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Participants will utilize a 3D printed knee extension device and an at-home prehabilitation program designed to be used with the 3D printed knee extension device. Receives: Device: 3D printed knee extender device |
| Control Arm | Other | Participants will receive the standard prehabilitation education at Sanford and provided exercises to do at home. Receives: Other: Standard Prehabilitation Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Extension Range of Motion
Knee extension range of motion is measured by a trained study member who is blinded to the participant's study group using a goniometer in clinic. Participants are seated on the exam table with their leg maximally extended. The center of the goniometer is placed over the lateral epicondyle of the affected knee. One of the goniometer arms is aimed proximally, pointing toward the greater trochanter of the hip. The other arm is aimed distally, pointing toward the lateral malleolus of the ankle. The study member then reads the angle created by the arms of the goniometer in this position.
Measured: Change from baseline range of motion to day of ACL reconstruction.
Time to Achieve Full Knee Extension
Full knee extension will be measured at home by participants by placing a clicking device under their knee which will produce an audible "click" when the knee is fully extended, and the clicker is depressed. Participants in the control and experimental groups record whether they are able to depress the clicker in at-home logs daily paper logs and online surveys in RedCap, respectively.
Measured: Through study completion, an average of 4 weeks.
Secondary outcomes (4)
Knee Swelling
Participant knee swelling is measured by a trained study member who is blinded to the participant's study group in clinic. Circumference of the knee is used as a proxy for knee swelling, and is measured by wrapping a tape measure around the circumference of the knee just proximal to the superior pole of the patella with resting tension.
Measured: Through study completion, an average of 4 weeks.
Average Daily Pain Level
Participant average pain level for control and experimental groups is recorded in an at-home daily paper log and online surveys in RedCap, respectively.
Measured: From baseline until their ACL reconstruction, assessed up to an average of 4 weeks.
Water Bottles Used with Knee Sling
Participants in the experimental group record how many water bottles they use to weigh down their knee sling, up to a maximum of ten water bottles, in online surveys in RedCap in each of the morning, afternoon, and evening prehab sessions.
Measured: From baseline until their ACL reconstruction, assessed up to an average of 4 weeks.
Minutes Spent Using Knee Sling
Participants in the experimental group record how many minutes they spend using the knee sling, up to a maximum of ten minutes, in online surveys in RedCap in each of the morning, afternoon, and evening prehab sessions.
Measured: Through study completion, an average of 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start15 Jun 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Why it stopped: Study structure was flawed and as a result the investigator had closed the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACLStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanford Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathan Skelley, MD, Principal investigator, Sanford Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878652
- Sponsor's protocol ID
- Playmaker
- Status last verified
- Mar 2024
- First submitted
- 28 Mar 2023
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of a 3D Printed Customized Knee Extender on Patient Outcomes Following ACL Injuries
- ClinicalTrials.gov ID
- NCT05878652
- Acronym / sponsor ID
- Playmaker
- Conditions
- ACL, ACL Injury
- Keywords
- Desktop 3D Printing, Knee Extender, Pre-habilitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study structure was flawed and as a result the investigator had closed the study.
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Sanford HealthUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 26 May 2023 (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 purpose of this study is to explore the development of, and patient outcomes associated with, the use of individually printed knee extender in conjunction with a video-based home pre-habilitation program for patients who have suffered an ACL rupture before surgery.
Detailed description
The proposed study will assess the efficacy of utilizing desktop 3DP for patient-specific knee extenders paired with a video-based home pre-habilitation program to address the aforementioned barriers. If the novel device and home program is found to be a viable treatment option, this may improve or replace current treatments for knee pre-habilitation, increase accessibility to proper treatment, and reduce cost and time burden on patients, PTs, and providers. The study will offer a greater understanding of potential improvements to clinical workflows and efficiencies through using 3DP. This technology is an under- utilized resource; further research into the applications of 3DP in the field of orthopaedics will provide opportunities to improve patient care and outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Device: 3D printed knee extender deviceParticipants will utilize a 3D printed knee extension device and an at-home prehabilitation program designed to be used with the 3D printed knee extension device. |
| Control Arm | Other | Other: Standard Prehabilitation EducationParticipants will receive the standard prehabilitation education at Sanford and provided exercises to do at home. |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 14-60 years old patients who have suffered an isolated primary ACL rupture
Key exclusion criteria (3 listed)
- Patients who have already attained full knee extension
- Open skin wounds that would come into contact with the device
- Pregnant women
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 |
|---|---|---|
| 3D printed knee extender deviceParticipants will receive the standard of prehabilitation education at Sanford as well as a 3D printed knee extension device with sealed water bottles and a home prehabilitation program designed to be used with the 3D printed knee extension device. | Device | Experimental Arm |
| Standard Prehabilitation EducationParticipants in the control group will receive the standard prehabilitation education at Sanford and provided exercises to do at home. | Other | Control Arm |
Primary outcome
Knee Extension Range of Motion
Time frame: Change from baseline range of motion to day of ACL reconstruction.
Knee extension range of motion is measured by a trained study member who is blinded to the participant's study group using a goniometer in clinic. Participants are seated on the exam table with their leg maximally extended. The center of the goniometer is placed over the lateral epicondyle of the affected knee. One of the goniometer arms is aimed proximally, pointing toward the greater trochanter of the hip. The other arm is aimed distally, pointing toward the lateral malleolus of the ankle. The study member then reads the angle created by the arms of the goniometer in this position.
Time to Achieve Full Knee Extension
Time frame: Through study completion, an average of 4 weeks.
Full knee extension will be measured at home by participants by placing a clicking device under their knee which will produce an audible "click" when the knee is fully extended, and the clicker is depressed. Participants in the control and experimental groups record whether they are able to depress the clicker in at-home logs daily paper logs and online surveys in RedCap, respectively.
4 secondary outcomes
Knee Swelling
Time frame: Through study completion, an average of 4 weeks.
Average Daily Pain Level
Time frame: From baseline until their ACL reconstruction, assessed up to an average of 4 weeks.
Water Bottles Used with Knee Sling
Time frame: From baseline until their ACL reconstruction, assessed up to an average of 4 weeks.
Minutes Spent Using Knee Sling
Time frame: Through study completion, an average of 4 weeks.
Results and safety
The study was stopped early (reason given: Study structure was flawed and as a result the investigator had closed the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
Related trials for ACL
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
RecruitingObservational study
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
ACL Tears
Not yet recruiting
Three-dimensional Biomechanics of the Lower Limbs in Healthy Volunteers: Establishment of a Reference Database Using the MERItest® System
Healthy Adult Participants, Anterior Cruciate Ligament (ACL)
Recruiting
Quadriceps Strengthening ACL Reconstruction
ACL Tear
RecruitingObservational study
Evaluation of the Correlation Between Bone Tunnel Projection Placement and Clinical Outcomes in Anterior Cruciate Ligament Reconstruction Surgery
Anterior Cruciate Ligament Injury, Tunneling Technique
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.
Nathan Skelley, MD principal investigator
Sanford Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printed knee extender device and Standard Prehabilitation Education in people with ACL and ACL Injury, run by Sanford Health 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 1 inclusion and 3 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: stopped early, as of the sponsor's last update on 8 Mar 2024. 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 was stopped early (reason given: Study structure was flawed and as a result the investigator had closed the study.). Results are not available in the source record.
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 Extension Range of Motion (time frame: Change from baseline range of motion to day of ACL reconstruction.). The study lists 2 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 8 Mar 2024.