Osteoarthritis in the KneeNCT06928181
Effects of Passive Blood-Flow-Restriction on Muscle Atrophy and Pain After Elective Total Knee Arthroplasty
A study testing Blood Flow Restriction Training in people with Osteoarthritis in the Knee, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
This study investigated the effects of passive Blood-Flow-Restriction Training after elective Total Knee Arthroplasty Surgery on Muscle Atrophy and Postoperative Pain. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis in the Knee
- What is being tested?
- Blood Flow Restriction Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2024to 20 Feb 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The study includes all patients with a medical indication for surgical treatment of the lower extremity (total or partial knee arthroplasty) who are eligible for either inpatient or outpatient rehabilitation.
- All participating patients have signed the informed consent form for study participation as well as the data protection declaration after receiving comprehensive explanation, counseling, and information.
- All patients have consented to the surgical procedure and received medical clearance for surgery from both the orthopedic and anesthesiology departments.
Who cannot join
- Acute or chronic infections of the extremities
- Open wounds on the lower extremity
- Pregnancy and breastfeeding
- Patients who are unable to understand the patient information and study design (e.g., due to language barriers), or whose compliance is deemed insufficient by the study team
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Passive Blood-Flow-Restriction Training on Muscle Atrophy and Pain After Elective Total Knee Arthroplasty
This study investigated the effects of passive Blood-Flow-Restriction Training after elective Total Knee Arthroplasty Surgery on Muscle Atrophy and Postoperative Pain.
Read the detailed description
This is the first study invesigating the effects of passive Blood-Flow-Restriction Training on Muscle Atrophy and Postoperative Pain after Elective Total Knee Arthroplasty Surgery.
- Conditions
- Osteoarthritis in the Knee
- Being tested
- Blood Flow Restriction Training, Sham-BFR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restriction TrainingOther
BFR training involves the application of blood flow restriction during passive or active movement interventions to elicit an additional metabolic stimulus. The cuffs are applied as proximally as possible on the thigh, and a pressure is exerted during the movement that partially restricts venous return from the limb, resulting in venous pooling. Venous occlusion is achieved using a cuff system commonly employed in resistance training (Delfi Medical Innovations Inc., Vancouver, Canada; CE-certified). The pressure applied is individually determined at the start of each training session based on the participant's arterial occlusion pressure, measured via duplex ultrasonography. For this measurement, the participant rests in a supine position while the cuff is gradually inflated until no blood flow is detectable in the limb (i.e., occlusion pressure). For the BFR intervention, 60-80% of this occlusion pressure is subsequently applied. The exercise protocol consists of daily
Sham-BFROther
Patients in the control group (CG) follow the same exercise protocol as those in the BFR intervention group; however, the cuff is only inflated to a minimal pressure of 20 mmHg. This pressure does not induce any relevant venous stasis, nor can any local or systemic metabolic effects be expected.
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | Sham-BFR Intervention with 20mmHg Receives: Other: Sham-BFR |
| Intervention | Experimental | BFR-Intervention with 80% of the 1RM Receives: Other: Blood Flow Restriction Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Mass
Lean Body Mass in DEXA anaylsis
Measured: Three Months
Postoperative Pain
0-100 mm VAS
Measured: Three Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start1 Apr 2024
- Primary completion20 Feb 2025
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis in the KneeStudies 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
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Franz, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928181
- Sponsor's protocol ID
- 2023_A_TKA_BFR
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Passive Blood-Flow-Restriction Training on Muscle Atrophy and Pain After Elective Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06928181
- Acronym / sponsor ID
- 2023_A_TKA_BFR
- Conditions
- Osteoarthritis in the Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 15 Apr 2025 (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.
This study investigated the effects of passive Blood-Flow-Restriction Training after elective Total Knee Arthroplasty Surgery on Muscle Atrophy and Postoperative Pain.
Detailed description
This is the first study invesigating the effects of passive Blood-Flow-Restriction Training on Muscle Atrophy and Postoperative Pain after Elective Total Knee Arthroplasty Surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Other: Sham-BFRSham-BFR Intervention with 20mmHg |
| Intervention | Experimental | Other: Blood Flow Restriction TrainingBFR-Intervention with 80% of the 1RM |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- The study includes all patients with a medical indication for surgical treatment of the lower extremity (total or partial knee arthroplasty) who are eligible for either inpatient or outpatient rehabilitation.
- All participating patients have signed the informed consent form for study participation as well as the data protection declaration after receiving comprehensive explanation, counseling, and information.
- All patients have consented to the surgical procedure and received medical clearance for surgery from both the orthopedic and anesthesiology departments.
Key exclusion criteria (4 listed)
- Acute or chronic infections of the extremities
- Open wounds on the lower extremity
- Pregnancy and breastfeeding
- Patients who are unable to understand the patient information and study design (e.g., due to language barriers), or whose compliance is deemed insufficient by the study team
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 |
|---|---|---|
| Blood Flow Restriction TrainingBFR training involves the application of blood flow restriction during passive or active movement interventions to elicit an additional metabolic stimulus. The cuffs are applied as proximally as possible on the thigh, and a pressure is exerted during the movement that partially restricts venous return from the limb, resulting in venous pooling. Venous occlusion is achieved using a cuff system commonly employed in resistance training (Delfi Medical Innovations Inc., Vancouver, Canada; CE-certified). The pressure applied is individually determined at the start of each training session based on the participant's arterial occlusion pressure, measured via duplex ultrasonography. For this measurement, the participant rests in a supine position while the cuff is gradually inflated until no blood flow is detectable in the limb (i.e., occlusion pressure). For the BFR intervention, 60-80% of this occlusion pressure is subsequently applied. The exercise protocol consists of daily | Other | Intervention |
| Sham-BFRPatients in the control group (CG) follow the same exercise protocol as those in the BFR intervention group; however, the cuff is only inflated to a minimal pressure of 20 mmHg. This pressure does not induce any relevant venous stasis, nor can any local or systemic metabolic effects be expected. | Other | Control |
Primary outcome
Muscle Mass
Time frame: Three Months
Lean Body Mass in DEXA anaylsis
Postoperative Pain
Time frame: Three Months
0-100 mm VAS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction Training in people with Osteoarthritis in the Knee, run by University Hospital, Bonn at 1 site in Germany.
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 4 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: finished, as of the sponsor's last update on 15 Apr 2025. 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 Germany. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Muscle Mass (time frame: Three Months). 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 15 Apr 2025.