ArthroplastyNCT00756483
Stability Plus - Outcomes From Extended Continuum of Care
An observational study of Arthroplasty, run by Stability Plus, LLC at 1 site in United States.
Trial summary
Basic Protocol 1. Identify participant(s) 2. Request patient participation/Acquire Consent 3. Register patient at www.stabilityplus.net through the LOGIN tab Patient ID (Name/Initials/SSN or any combination thereof) Gender Age Surgical Procedure Date of Surgery Select Basic Exercise Program that corresponds with… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Arthroplasty
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Oct 2009
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients that have undergone total joint replacement - hip or knee
Who may be able to join
- Undergone total joint replacement
- Must be able to complete pre-operative strength assessment
- Must be able to exercise using specified resistive bands
Who cannot join
- Non-ambulatory patients
Trial locations and contacts
1 site in 1 country.
Ann M Juengermann contact
Linda C Landry contact
United States1 site
University of Missouri Hospital
Columbia, Missouri, 65212
Linda C Landry, LandryL@health.missouri.edu
Ann M Juengermann, JuengermannA@health.missouri.edu
About this study
Official title: Study the Effects of Pre- and Post-Operative Resistive Exercise in Total Arthroplasty Patients Using the Stability Plus Exercise System
Basic Protocol
- Identify participant(s)
- Request patient participation/Acquire Consent
- Register patient at www.stabilityplus.net through the LOGIN tab
- Patient ID (Name/Initials/SSN or any combination thereof)
- Gender
- Age
- Surgical Procedure
- Date of Surgery
- Select Basic Exercise Program that corresponds with Surgical Procedure
- Perform Initial Assessment using Basic Exercises for the Surgical Procedure
- Enter Assessment Data at www.stabilityplus.net (through the LOGIN tab/Portal)
- Within portal, modify Basic Exercise Program to create customized Stability Plus prescription for the patient
- Monitor patient progress through Stability Plus portal.
- Conditions
- Arthroplasty
- Keywords
- Resistance, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| M, 1 | Male patients that have undergone total knee replacement | |
| F, 1 | Female patients that have undergone total knee replacement | |
| M, 2 | Male patients that have undergone total hip replacement | |
| F, 2 | Female patients that have undergone total hip replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre- and post- study strength assessment tests for joint specific exercises
Measured: 3 months, 6 months and 12 months
Secondary outcomes (1)
Reduced recovery time versus current norm
Measured: 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionMar 2009 (estimated)
- Study completionOct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthroplastyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stability Plus, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Missouri-Columbia
- Investigators
- James T Yost, Study director, Stability Plus, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00756483
- Sponsor's protocol ID
- 1107957-UMC
- Status last verified
- Sep 2008
- First submitted
- 18 Sep 2008
- Last updated
- 22 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study the Effects of Pre- and Post-Operative Resistive Exercise in Total Arthroplasty Patients Using the Stability Plus Exercise System
- ClinicalTrials.gov ID
- NCT00756483
- Acronym / sponsor ID
- 1107957-UMC
- Conditions
- Arthroplasty
- Keywords
- Resistance, Exercise
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Stability Plus, LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Missouri-Columbia
- Study start
- Oct 2008
- Primary completion
- Mar 2009 (estimated)
- Study completion
- Oct 2009 (estimated)
- First posted
- 22 Sep 2008 (estimated)
- 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.
Basic Protocol
- Identify participant(s)
- Request patient participation/Acquire Consent
- Register patient at www.stabilityplus.net through the LOGIN tab
- Patient ID (Name/Initials/SSN or any combination thereof)
- Gender
- Age
- Surgical Procedure
- Date of Surgery
- Select Basic Exercise Program that corresponds with Surgical Procedure
- Perform Initial Assessment using Basic Exercises for the Surgical Procedure
- Enter Assessment Data at www.stabilityplus.net (through the LOGIN tab/Portal)
- Within portal, modify Basic Exercise Program to create customized Stability Plus prescription for the patient
- Monitor patient progress through Stability Plus portal.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| M, 1 | – | –Male patients that have undergone total knee replacement |
| F, 1 | – | –Female patients that have undergone total knee replacement |
| M, 2 | – | –Male patients that have undergone total hip replacement |
| F, 2 | – | –Female patients that have undergone total hip replacement |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients that have undergone total joint replacement - hip or knee
Key inclusion criteria (3 listed)
- Undergone total joint replacement
- Must be able to complete pre-operative strength assessment
- Must be able to exercise using specified resistive bands
Key exclusion criteria (1 listed)
- Non-ambulatory patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pre- and post- study strength assessment tests for joint specific exercises
Time frame: 3 months, 6 months and 12 months
1 secondary outcome
Reduced recovery time versus current norm
Time frame: 3 months, 6 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2008.
Related trials for Arthroplasty
Not yet recruiting
Is Routine Dental Clearance or Antibiotic Prophylaxis Before Dental Procedures Necessary in Total Joint Arthroplasty?
Elective Primary THA or TKA
Enrolling by invitation
Comparison of Functional Results of ADM X3-MoP Cup (Stryker) and a CoC Cup (Zimmer) in Young Patients
Arthroplasties, Hip Replacement
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
Active, not recruiting
At Home, Digital Rehabilitation for Patients After Reverse Total Shoulder Arthroplasty
Arthroplasty, Replacement, Shoulder, Reverse Total Shoulder Arthroplasty
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
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.
Ann M Juengermann contact
Linda C Landry contact
James T Yost study director
Stability Plus, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty, run by Stability Plus, LLC 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Sep 2008. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ann M Juengermann (JuengermannA@health.missouri.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre- and post- study strength assessment tests for joint specific exercises (time frame: 3 months, 6 months and 12 months). 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 22 Sep 2008.