Total Knee ArthroplastyNCT02763488
Blood Flow Restriction Training Following Total Knee Arthroplasty
A study testing DelfiPTS tourniquet system and Standard physical therapy in people with Total Knee Arthroplasty and Osteoarthritis, run by San Antonio Military Medical Center at 1 site in United States.
Trial summary
This study will evaluate blood flow restriction training as a rehabilitation modalities following total knee arthroplasty in order to determine if patient reported outcomes and objective functional outcomes can be improved through post-operative rehabilitation compared to standard physical therapy modalities currently… Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Total Knee Arthroplasty, Osteoarthritis
- What is being tested?
- DelfiPTS tourniquet system and Standard physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Jun 2019
- 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- S/p primary Total Knee Arthroplasty and cleared by surgeon for continued physical therapy
- Males and females 50-79 years of age
- Ability to consent to study enrollment
- Able to participate fully in physical therapy
- Tricare Beneficiary
- Implant restricted: primary cruciate retaining or posterior stabilized total knee arthroplasty
- Knee range of motion of surgical extremity from a minimum of 5 degrees from full extension to 90 degrees of flexion**
- only screened at secondary screening
Who cannot join
- Unable to consent for study participation
- Unable to participate in preoperative testing
- Any ligamentous or bony reconstruction performed at time of surgery that limits weight bearing or rehabilitation protocol
- History of deep venous thrombosis
- Injury or recent procedure to contralateral extremity within past 6 months
- History of endothelial dysfunction
Show all 21Show fewer
- History of Peripheral Vascular Disease
- Patient endorsement of easy bruising
- Revision Total Knee Arthroplasty
- History of Surgical wound complication on involved extremity
- History of Cerebral Vascular Event
- History of Dementia
- History of Neuromuscular disorder
- History of Chronic Obstructive Pulmonary Disease requiring oxygen supplementation or limiting participants ability to perform therapy and/or testing
- History of previous intra-articular fracture of surgical extremity requiring open reduction and internal fixation or external fixation
- History of Sickle cell trait and/or disease
- Previously participated in blood flow restriction training interventions
- Planned or unplanned additional surgical procedures affecting their ability to complete all session of physical therapy or testing during the following 6 months from their primary intervention
- Patient reported history of functionally limiting arthritis in non-surgical lower extremity or ipsilateral hip or ankle
- History or previous contralateral total knee arthroplasty
- Any history of previous total hip arthroplasty
Trial locations and contacts
1 site in 1 country.
United States1 site
San Antonio Military Medical Center
Fort Sam Houston, Texas, 78234
About this study
Official title: Blood Flow Restriction Training Following Primary Total Knee Arthroplasty
This study will evaluate blood flow restriction training as a rehabilitation modalities following total knee arthroplasty in order to determine if patient reported outcomes and objective functional outcomes can be improved through post-operative rehabilitation compared to standard physical therapy modalities currently in use.
Read the detailed description
Patients will be enrolled preoperatively in order to measure preoperative functional measures. They will then be followed at predetermined intervals post-operatively. All subjects will begin the study related physical therapy 6 weeks post-operatively and continue for 12 sessions. At the conclusion of 12 sessions, subjects will be retested to determine improvement. Subjects will then be followed for two years post-operative.
- Conditions
- Total Knee Arthroplasty, Osteoarthritis
- Being tested
- DelfiPTS tourniquet system, Standard physical therapy
- Keywords
- blood flow restriction training, occlusion training, total knee arthroplasty, post-operative rehabilitation
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DelfiPTS tourniquet systemDevice
Standard physical therapyOther
| Study group | Role | What they receive |
|---|---|---|
| Standard physical therapy | Active comparator | These individuals will conduct physical therapy for 12 sessions as per the institutional standard physical therapy protocol Receives: Other: Standard physical therapy |
| Blood flow restriction | Experimental | These individuals will conduct physical therapy for 12 sessions with the addition of blood flow restriction interventions to their standard physical therapy Receives: Device: DelfiPTS tourniquet system |
What is being measured
The primary outcome is the main question the study is designed to answer.
quadriceps strength
quadriceps strength via dynamometer
Measured: baseline up to 2 years post operative
Secondary outcomes (9)
Patient reported outcome 1: KOOS
Patient reported measure of subject pain and function
Measured: baseline up to 2 years post operative
Patient reported outcome 2: PROMIS Global Health
PROMIS Global Health is a global measure of mental and physical health
Measured: baseline up to 2 years post operative
Patient reported outcome 3: Promis-29
NIH validated patient reported outcome measure evaluating multiple mental and physical domains
Measured: baseline up to 2 years post operative
Patient reported outcome 4: Pain Visual analog score
Patient pain rating
Measured: baseline up to 2 years post operative
Physical Outcome measure 1: Four square step test
Validated functional outcome evaluating lower extremity function
Measured: baseline up to 2 years post operative
Physical Outcome measure 2: Sit to stand test
Validated functional outcome evaluating lower extremity function
Measured: baseline up to 2 years post operative
Physical Outcome measure 3: 6 minute walk test
Validated functional outcome evaluating lower extremity function
Measured: baseline up to 2 years post operative
Physical Outcome measure 4: Timed up and go test
Validated functional outcome evaluating lower extremity function
Measured: baseline up to 2 years post operative
Physical Outcome measure 5: Timed stair ascent
Validated functional outcome evaluating lower extremity function
Measured: baseline up to 2 years post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Antonio Military Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, David Tennent, San Antonio Military Medical Center
- Investigators
- David J Tennent, MD, Principal investigator, San Antonio Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763488
- Sponsor's protocol ID
- C.2016.109
- Status last verified
- Jun 2016
- First submitted
- 2 May 2016
- Last updated
- 16 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow Restriction Training Following Primary Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02763488
- Acronym / sponsor ID
- C.2016.109
- Conditions
- Total Knee Arthroplasty, Osteoarthritis
- Keywords
- blood flow restriction training, occlusion training, total knee arthroplasty, post-operative rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- San Antonio Military Medical CenterUS federal agency
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 5 May 2016 (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.
This study will evaluate blood flow restriction training as a rehabilitation modalities following total knee arthroplasty in order to determine if patient reported outcomes and objective functional outcomes can be improved through post-operative rehabilitation compared to standard physical therapy modalities currently in use.
Detailed description
Patients will be enrolled preoperatively in order to measure preoperative functional measures. They will then be followed at predetermined intervals post-operatively. All subjects will begin the study related physical therapy 6 weeks post-operatively and continue for 12 sessions. At the conclusion of 12 sessions, subjects will be retested to determine improvement. Subjects will then be followed for two years post-operative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard physical therapy | Active comparator | Other: Standard physical therapyThese individuals will conduct physical therapy for 12 sessions as per the institutional standard physical therapy protocol |
| Blood flow restriction | Experimental | Device: DelfiPTS tourniquet systemThese individuals will conduct physical therapy for 12 sessions with the addition of blood flow restriction interventions to their standard physical therapy |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- S/p primary Total Knee Arthroplasty and cleared by surgeon for continued physical therapy
- Males and females 50-79 years of age
- Ability to consent to study enrollment
- Able to participate fully in physical therapy
- Tricare Beneficiary
Key exclusion criteria (21 listed)
- Unable to consent for study participation
- Unable to participate in preoperative testing
- Any ligamentous or bony reconstruction performed at time of surgery that limits weight bearing or rehabilitation protocol
- History of deep venous thrombosis
- Injury or recent procedure to contralateral extremity within past 6 months
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 |
|---|---|---|
| DelfiPTS tourniquet system | Device | Blood flow restriction |
| Standard physical therapy | Other | Standard physical therapy |
Primary outcome
quadriceps strength
Time frame: baseline up to 2 years post operative
quadriceps strength via dynamometer
9 secondary outcomes
Patient reported outcome 1: KOOS
Time frame: baseline up to 2 years post operative
Patient reported outcome 2: PROMIS Global Health
Time frame: baseline up to 2 years post operative
Patient reported outcome 3: Promis-29
Time frame: baseline up to 2 years post operative
Patient reported outcome 4: Pain Visual analog score
Time frame: baseline up to 2 years post operative
Physical Outcome measure 1: Four square step test
Time frame: baseline up to 2 years post operative
Physical Outcome measure 2: Sit to stand test
Time frame: baseline up to 2 years post operative
Physical Outcome measure 3: 6 minute walk test
Time frame: baseline up to 2 years post operative
Physical Outcome measure 4: Timed up and go test
Time frame: baseline up to 2 years post operative
Physical Outcome measure 5: Timed stair ascent
Time frame: baseline up to 2 years post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2016.
- Individual participant dataSharing planned: No
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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.
David J Tennent, MD principal investigator
San Antonio Military Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DelfiPTS tourniquet system and Standard physical therapy in people with Total Knee Arthroplasty and Osteoarthritis, run by San Antonio Military Medical Center 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 8 inclusion and 21 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 16 Jun 2016. 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?
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?
quadriceps strength (time frame: baseline up to 2 years post operative). 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 16 Jun 2016.