Osteo Arthritis KneeNCT05179044
Utilization of a Knee Brace With Extension Swing
A study testing Guardian Sport Rehabilitator knee brace in people with Osteo Arthritis Knee, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this research is to help determine if use of the Guardian brace during prehab and post-op rehab after TKA can help improve functional outcomes and reduce the incidence of post-operative flexion contractures which reduce knee range of motion after surgery. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Guardian Sport Rehabilitator knee brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2022to 1 Jul 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥18 years of age
- Surgical candidates undergoing primary TKA
- Surgical candidates with pre-operative flexion contracture of 10 degrees or greater
- Patient is willing to cooperate and follow study protocol and visit schedule
Who cannot join
- Patient is pregnant
- Patient is unable to provide written consent
- Patient has psychiatric disorder that precludes safe study participation
- Patients with a prior history of surgery in the affected knee
- Vulnerable patient populations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Utilization of a Knee Brace With Extension Swing Assist Peri-operatively to Prevent Flexion Contractures and Improves Quadriceps Strength After Total Knee Arthroplasty (TKA)
The purpose of this research is to help determine if use of the Guardian brace during prehab and post-op rehab after TKA can help improve functional outcomes and reduce the incidence of post-operative flexion contractures which reduce knee range of motion after surgery.
Read the detailed description
This will be a prospective study with consecutive TKA patients with pre-operative flexion contractures of 5 degrees or greater. Patients will be randomized to one of two groups: 1) use of the Guardian knee brace peri-operatively, and 2) no Guardian brace use.
Pre-operative range of motion (ROM) and leg strength will be tested (4 to 6 weeks pre-operatively and the week before surgery) as well as during the recovery period at 6 weeks and 3 months post-operatively. The study will attempt to quantify quadriceps and hamstring strength using a Medical Engineering TKR2000, which can digitally measure quadriceps and hamstring strength with accuracy equivalent to a Biodex Dynanometer. The TKR2000 also accurately measures terminal flexion and extension of the lower extremity. Pre- and post-operative patient reported outcome measures (KOOS JR. score) will also be collected.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Guardian Sport Rehabilitator knee brace
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guardian Sport Rehabilitator knee braceDevice
The Guardian Sport Rehabilitator knee brace has pneumatic condyles that can be used to support and control the knee joint as well as an extension swing assist design which automatically assists in extending the knee when the patient themselves may guard against it. The Guardian Rehabilitator Knee Brace is considered by the FDA as a Class I external medical device. It is used on label and therefore exempt from IDE requirements.The Guardian Brace FDA registration to manufacturer external limb devices is attached for reference.
| Study group | Role | What they receive |
|---|---|---|
| Guardian knee brace group | Experimental | Patients undergoing elective Total knee arthroplasty (TKA) by surgeons from NYU Langone with the presence of a pre-operative knee flexion contracture greater than 5 degrees and willingness to participate in our institution's outpatient rehabilitation and physical therapy. Those randomized to this group will be fitted with a Guardian Rehabilitator Brace. Receives: Device: Guardian Sport Rehabilitator knee brace |
| No Guardian brace used group | No intervention | Patients undergoing elective Total knee arthroplasty (TKA) by surgeons from NYU Langone with the presence of a pre-operative knee flexion contracture greater than 5 degrees and willingness to participate in our institution's outpatient rehabilitation and physical therapy as part of standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in extensor leg strength
Measured by the TKR2000 which is a patient controlled mechanical over-pressure stretching and strengthening device designed and developed to diminish issues with muscle guarding. The device uses a lever arm with a comfortable foam roller padding placed against the patients' ankle and is moved by an electric actuator. At each scheduled visit, subjects will be examined to determine extensor leg strength on the affected leg.
Measured: Visit 1( 1 week pre surgery), Visit 2 (2 weeks post surgery) , Visit 3 (6 weeks post surgery), Visit 4 ( 12 weeks post surgery)
Change in flexor leg strength
Measured by the TKR2000 which is a patient controlled mechanical over-pressure stretching and strengthening device designed and developed to diminish issues with muscle guarding. The device uses a lever arm with a comfortable foam roller padding placed against the patients' ankle and is moved by an electric actuator. At each scheduled visit, subjects will be examined to determine flexor leg strength on the affected leg.
Measured: Visit 1( 1 week pre surgery), Visit 2 (2 weeks post surgery) , Visit 3 (6 weeks post surgery), Visit 4 ( 12 weeks post surgery)
Change in range of motion following knee replacement surgery
At each scheduled visit, subjects will be examined to determine their range of motion (ROM) in the affected leg to see the range of motion change from pre-op to post- op.
Measured: Visit 1( 1 week pre surgery), Visit 2 (2 weeks post surgery) , Visit 3 (6 weeks post surgery), Visit 4 ( 12 weeks post surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start7 Feb 2022
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Why it stopped: Logistic difficulties and loss of support from bracing company.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morteza Meftah, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179044
- Sponsor's protocol ID
- 20-00143
- Status last verified
- Jul 2023
- First submitted
- 16 Dec 2021
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of a Knee Brace With Extension Swing Assist Peri-operatively to Prevent Flexion Contractures and Improves Quadriceps Strength After Total Knee Arthroplasty (TKA)
- ClinicalTrials.gov ID
- NCT05179044
- Acronym / sponsor ID
- 20-00143
- Conditions
- Osteo Arthritis Knee
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Logistic difficulties and loss of support from bracing company.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 5 Jan 2022 (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 research is to help determine if use of the Guardian brace during prehab and post-op rehab after TKA can help improve functional outcomes and reduce the incidence of post-operative flexion contractures which reduce knee range of motion after surgery.
Detailed description
This will be a prospective study with consecutive TKA patients with pre-operative flexion contractures of 5 degrees or greater. Patients will be randomized to one of two groups: 1) use of the Guardian knee brace peri-operatively, and 2) no Guardian brace use.
Pre-operative range of motion (ROM) and leg strength will be tested (4 to 6 weeks pre-operatively and the week before surgery) as well as during the recovery period at 6 weeks and 3 months post-operatively. The study will attempt to quantify quadriceps and hamstring strength using a Medical Engineering TKR2000, which can digitally measure quadriceps and hamstring strength with accuracy equivalent to a Biodex Dynanometer. The TKR2000 also accurately measures terminal flexion and extension of the lower extremity. Pre- and post-operative patient reported outcome measures (KOOS JR. score) will also be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guardian knee brace group | Experimental | Device: Guardian Sport Rehabilitator knee bracePatients undergoing elective Total knee arthroplasty (TKA) by surgeons from NYU Langone with the presence of a pre-operative knee flexion contracture greater than 5 degrees and willingness to participate in our institution's outpatient rehabilitation and physical therapy. Those randomized to this group will be fitted with a Guardian Rehabilitator Brace. |
| No Guardian brace used group | No intervention | –Patients undergoing elective Total knee arthroplasty (TKA) by surgeons from NYU Langone with the presence of a pre-operative knee flexion contracture greater than 5 degrees and willingness to participate in our institution's outpatient rehabilitation and physical therapy as part of standard of care. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients ≥18 years of age
- Surgical candidates undergoing primary TKA
- Surgical candidates with pre-operative flexion contracture of 10 degrees or greater
- Patient is willing to cooperate and follow study protocol and visit schedule
Key exclusion criteria (5 listed)
- Patient is pregnant
- Patient is unable to provide written consent
- Patient has psychiatric disorder that precludes safe study participation
- Patients with a prior history of surgery in the affected knee
- Vulnerable patient populations
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 |
|---|---|---|
| Guardian Sport Rehabilitator knee braceThe Guardian Sport Rehabilitator knee brace has pneumatic condyles that can be used to support and control the knee joint as well as an extension swing assist design which automatically assists in extending the knee when the patient themselves may guard against it. The Guardian Rehabilitator Knee Brace is considered by the FDA as a Class I external medical device. It is used on label and therefore exempt from IDE requirements.The Guardian Brace FDA registration to manufacturer external limb devices is attached for reference. | Device | Guardian knee brace group |
Primary outcome
Change in extensor leg strength
Time frame: Visit 1( 1 week pre surgery), Visit 2 (2 weeks post surgery) , Visit 3 (6 weeks post surgery), Visit 4 ( 12 weeks post surgery)
Measured by the TKR2000 which is a patient controlled mechanical over-pressure stretching and strengthening device designed and developed to diminish issues with muscle guarding. The device uses a lever arm with a comfortable foam roller padding placed against the patients' ankle and is moved by an electric actuator. At each scheduled visit, subjects will be examined to determine extensor leg strength on the affected leg.
Change in flexor leg strength
Time frame: Visit 1( 1 week pre surgery), Visit 2 (2 weeks post surgery) , Visit 3 (6 weeks post surgery), Visit 4 ( 12 weeks post surgery)
Measured by the TKR2000 which is a patient controlled mechanical over-pressure stretching and strengthening device designed and developed to diminish issues with muscle guarding. The device uses a lever arm with a comfortable foam roller padding placed against the patients' ankle and is moved by an electric actuator. At each scheduled visit, subjects will be examined to determine flexor leg strength on the affected leg.
Change in range of motion following knee replacement surgery
Time frame: Visit 1( 1 week pre surgery), Visit 2 (2 weeks post surgery) , Visit 3 (6 weeks post surgery), Visit 4 ( 12 weeks post surgery)
At each scheduled visit, subjects will be examined to determine their range of motion (ROM) in the affected leg to see the range of motion change from pre-op to post- op.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
Morteza Meftah, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guardian Sport Rehabilitator knee brace in people with Osteo Arthritis Knee, run by NYU Langone Health 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 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: withdrawn, as of the sponsor's last update on 24 Jul 2023. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in extensor leg strength (time frame: Visit 1( 1 week pre surgery), Visit 2 (2 weeks post surgery) , Visit 3 (6 weeks post surgery), Visit 4 ( 12 weeks post surgery)). The study lists 3 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 24 Jul 2023.