Arthropathy of KneeNCT03260699
Economic and Functional Impact of Peri-Operative Bracing for Primary Total Knee Arthroplasty (TKA)
A study testing OCSI Rehabilitator brace in people with Arthropathy of Knee, run by The Cleveland Clinic at 1 site in United States.
Trial summary
While bracing has been shown to be beneficial for patients with osteoarthritis (OA) in terms of function and strength, whether these unloader braces are also similarly beneficial after total knee arthroplasty (TKA) surgery needs to be examined. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Arthropathy of Knee
- What is being tested?
- OCSI Rehabilitator brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2017to 1 Jan 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 50 years or older
Who cannot join
- BMI > 40
- Radiographic deformity of greater than 10 degrees
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Determine the Economic and Functional Impact of Peri-Operative Extension Assist Pneumatic Bracing for Primary Total Knee Arthroplasty (TKA) Non-Inferiority Trial
While bracing has been shown to be beneficial for patients with osteoarthritis (OA) in terms of function and strength, whether these unloader braces are also similarly beneficial after total knee arthroplasty (TKA) surgery needs to be examined. Therefore the investigators questioned whether wearing a brace that has previously been shown to increase strength and function in OA patients can also increase strength and function in patients after TKA.
- Conditions
- Arthropathy of Knee
- Being tested
- OCSI Rehabilitator brace
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCSI Rehabilitator braceDevice
Guardian Brace features the innovative Rehabilitator™ line of gait correcting, leg strengthening braces. Rehabilitator™ Knee Braces are clinically proven to reduce UNBRACED pain, strengthen the affected leg, and significantly improve function after only 90 days of brace wear.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Subjects will receive two out-patient physical therapy (PT) visits per week for 2 weeks, followed by additional PT visits at clinician's discretion after TKA. |
| Bracing group | Experimental | Subjects will be fitted with the Ongoing Care Solutions, Inc (OCSI) Rehabilitator brace prior to surgery. This brace will be worn for 6 weeks before surgery. The brace will be worn again after surgery ~10 days after surgery or when staples are removed until the end of the study. Participants will also have two PT visits per week for 2 weeks, followed by additional PT visits at clinician's discretion. Receives: Device: OCSI Rehabilitator brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Physical Therapy Visits
Investigators will monitor the total number of physical therapy visits that was necessary to return to normal function between the control and bracing group and how it relates to overall cost.
Measured: Total number of visits from date of surgery to 12 weeks after surgery
Secondary outcomes (10)
Visual Analog Scale (VAS) for Pain (0-10 Scale)
Visual Analog Scale is a a pain scale assessment instrument that has been widely used to allow adult patients to report their pain level in musculoskeletal research studies. It is a continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length, anchored by 2 two ends representing the extremes of measurements with 0 point representing no pain and 10 representing the worst pain a patient may have had. Therefore, starting from zero point, increasing numbers demonstrate worse pain. Patient can pick a point on the scale that they believe represent their pain level at a given moment.
Measured: Change from baseline to 12 weeks after surgery
Timed up and go Test (Timed Measurement)
Used to assess a person's mobility and balance. It is measured in time units (seconds or minutes) using a stopwatch by a study personnel. To perform, the patient sits back in a standard arm chair and a line 3 meters, or 10 feet away on the floor is identified. At the investigator mark, the stopwatch is started and the patient is asked to stand up from chair, walk to the end of the line and come back to his chair at normal pace. The results is the time in seconds needed for the patient to perform the test (getting up from chair and coming back to it as timed by the investigator's stopwatch)
Measured: Change from baseline to 12 weeks after surgery
Timed Stair Climb (Timed Measurement Over Fixed Distance)
Used to assess a person's mobility and balance
Measured: Change from baseline to 12 weeks after surgery
One-leg Stance Time (Timed Measurement)
Used to assess a person's balance. Performed with eyes open and arms on hips. The patient is asked to stand unassisted on one leg and is timed in seconds (using stopwatch) from the time one foot is flexed off the floor to the time when it touches the ground or the standing leg or an arm leaves the hips.
Measured: Change from baseline to 12 weeks after surgery
6 Minute Walk Test (Distance Measurement)
Used to assess a person's endurance and aerobic capacity. The score of the test is distance a patient walks in 6 minutes. Longer distances walked by the patient in 6 minutes correlates with better performance. Distance is measured using distance measuring wheel.
Measured: Change from baseline to 12 weeks after surgery
Knee Society Score Questionnaire
Clinical outcome questionnaire developed by the consensus of the Knee Society. It comprises, a "Knee score" and a "Functional score." The Knee score assesses pain, stability, and range of motion. A maximum score of 100 is achieved by a painless, well-aligned knee with 125° range of motion, with neither anteroposterior nor mediolateral instability. Deductions are made for flexion contracture, extension lag, and malalignment. The Functional score assesses walking distance and stair climbing. A maximum score of 100 is assigned to individuals who can walk unlimited distances and can climb up and down stairs normally. Deductions are made for use of a walking stick or crutches. Therefore, higher scores correlate with better function and outcome.
Measured: Change from baseline to 12 weeks after surgery
Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.) Questionnaires
Clinical outcome questionnaire that measure joint-specific pain and physical function. It has seven questions that focus on three categories: joint pain, stiffness, and function, in daily living. Raw scores are added up (range 0-28) and converted to an interval score (0-100) using an interval table. The interval score represents a patients total joint disability where 0 corresponds to total joint disability and 100 perfect joint health.
Measured: Change from baseline to 12 weeks after surgery
Hospital for Special Surgery (HSS) Score (0-100 Scale)
Clinical outcome assessment tool. It is based on a total of 100 points. The score is divided into seven categories, which include pain, function, range of motion, muscle strength, flexion deformity, instability, and subtractions. The knee is initially given a score of 0, and additions or subtractions are made according to specific criteria. The higher the score, the better the outcome. Approximately 50% of the score is based on a patient interview and the remaining on physical exam.
Measured: Change from baseline to 12 weeks after surgery
Type of Pain Medication Used
Investigators will monitor the medical record for types of pain medications used.
Measured: Change from baseline to 12 weeks after surgery
Amount of Pain Medication Used
Investigators will monitor the medical record for the amount of pain medication used
Measured: Change from baseline to 12 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start5 Oct 2017
- Primary completion1 Jan 2018
- Study completion1 Jan 2018
Why it stopped: Study terminated per Ongoing Care Solutions, Inc.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arthropathy of KneeStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Higuera-Rueda, The Cleveland Clinic
- Investigators
- Spindler Kurt, MD, Study chair, Department Chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03260699
- Sponsor's protocol ID
- SHB-OCSI007
- Status last verified
- Sep 2019
- First submitted
- 10 Jul 2017
- Last updated
- 9 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Determine the Economic and Functional Impact of Peri-Operative Extension Assist Pneumatic Bracing for Primary Total Knee Arthroplasty (TKA) Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT03260699
- Acronym / sponsor ID
- SHB-OCSI007
- Conditions
- Arthropathy of Knee
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated per Ongoing Care Solutions, Inc.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 5 Oct 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 24 Aug 2017 (actual)
- Results
- Posted 14 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
While bracing has been shown to be beneficial for patients with osteoarthritis (OA) in terms of function and strength, whether these unloader braces are also similarly beneficial after total knee arthroplasty (TKA) surgery needs to be examined. Therefore the investigators questioned whether wearing a brace that has previously been shown to increase strength and function in OA patients can also increase strength and function in patients after TKA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Subjects will receive two out-patient physical therapy (PT) visits per week for 2 weeks, followed by additional PT visits at clinician's discretion after TKA. |
| Bracing group | Experimental | Device: OCSI Rehabilitator braceSubjects will be fitted with the Ongoing Care Solutions, Inc (OCSI) Rehabilitator brace prior to surgery. This brace will be worn for 6 weeks before surgery. The brace will be worn again after surgery ~10 days after surgery or when staples are removed until the end of the study. Participants will also have two PT visits per week for 2 weeks, followed by additional PT visits at clinician's discretion. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age: 50 years or older
Key exclusion criteria (2 listed)
- BMI > 40
- Radiographic deformity of greater than 10 degrees
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 |
|---|---|---|
| OCSI Rehabilitator braceGuardian Brace features the innovative Rehabilitator™ line of gait correcting, leg strengthening braces. Rehabilitator™ Knee Braces are clinically proven to reduce UNBRACED pain, strengthen the affected leg, and significantly improve function after only 90 days of brace wear. | Device | Bracing group |
Primary outcome
Number of Physical Therapy Visits
Time frame: Total number of visits from date of surgery to 12 weeks after surgery
Investigators will monitor the total number of physical therapy visits that was necessary to return to normal function between the control and bracing group and how it relates to overall cost.
10 secondary outcomes
Visual Analog Scale (VAS) for Pain (0-10 Scale)
Time frame: Change from baseline to 12 weeks after surgery
Timed up and go Test (Timed Measurement)
Time frame: Change from baseline to 12 weeks after surgery
Timed Stair Climb (Timed Measurement Over Fixed Distance)
Time frame: Change from baseline to 12 weeks after surgery
One-leg Stance Time (Timed Measurement)
Time frame: Change from baseline to 12 weeks after surgery
6 Minute Walk Test (Distance Measurement)
Time frame: Change from baseline to 12 weeks after surgery
Knee Society Score Questionnaire
Time frame: Change from baseline to 12 weeks after surgery
Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.) Questionnaires
Time frame: Change from baseline to 12 weeks after surgery
Hospital for Special Surgery (HSS) Score (0-100 Scale)
Time frame: Change from baseline to 12 weeks after surgery
Type of Pain Medication Used
Time frame: Change from baseline to 12 weeks after surgery
Amount of Pain Medication Used
Time frame: Change from baseline to 12 weeks after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Spindler Kurt, MD study chair
Department Chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCSI Rehabilitator brace in people with Arthropathy of Knee, run by The Cleveland Clinic 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 1 inclusion and 2 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 9 Oct 2019. 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?
Yes. Results are posted in the registry (first posted 14 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Physical Therapy Visits (time frame: Total number of visits from date of surgery to 12 weeks after surgery). 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 9 Oct 2019.