Osteoarthritis (OA) of the KneeNCT06964022
Impact of Blood-Flow-Restriction Prehabilitation on Pre- and Postoperative Rehabilitation After Total Knee Arthroplasty
A study testing BFR in people with Osteoarthritis (OA) of the Knee, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
Degenerative and traumatic diseases of the musculoskeletal system lead to increased immobility of a patient, which in turn results in muscle atrophy. BFR training is a training method in which a blood pressure cuff partially blocks the arterial blood flow to the exercising limb and completely blocks the venous blood… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis (OA) of the Knee
- What is being tested?
- BFR
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2023to 1 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for TKA Surgery
- Ability to perform prehabilitation exercise
Who cannot join
- Sickle Cell Anemia
- Iatrogenic changes in the vessels of the lower extremities (e.g. stents)
- Open wounds/Infection of the lower extremities
Trial locations and contacts
1 site in 1 country.
About this study
Degenerative and traumatic diseases of the musculoskeletal system lead to increased immobility of a patient, which in turn results in muscle atrophy. BFR training is a training method in which a blood pressure cuff partially blocks the arterial blood flow to the exercising limb and completely blocks the venous blood flow. During exercise, an externally induced venous occlusion occurs. This stimulus increases the metabolic stimulus in the occluded extremity - this means that strength can be increased even with low weights, which is why this training is also suitable for people who should not use high training loads due to injuries or operations.
- Conditions
- Osteoarthritis (OA) of the Knee
- Being tested
- Sham-BFR, BFR
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham-BFROther
Six-week prehabilitation program (2/week): Unilateral Leg Press and Leg extension exercise with 30% of the individual 1RM by using a sham-BFR intervention with 20mmHg exercise pressure.
BFROther
Six-week prehabilitation program (2/week): Unilateral Leg Press and Leg extension exercise with 30% of the individual 1RM by using a BFR intervention with an exercise pressure corresponding to 60% of the individual LOP.
| Study group | Role | What they receive |
|---|---|---|
| Active Control | Active comparator | Participants of this group were active controls, exercising with a sham-BFR intervention during prehabilitation. Receives: Other: Sham-BFR |
| Intervention Group | Experimental | Participants of this group were exercising with a BFR intervention during prehabilitation. Receives: Other: BFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Pain Value
Subjective pain perception, assessed by visual analog scale (0-100mm)
Measured: Pre- to 6 weeks Post Surgery
Muscle Strength
Muscle Strength assessed by isometric maximal test (Nm)
Measured: Pre- to 6 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 posted9 May 2025
- Study start1 Jan 2023
- Primary completion31 Dec 2024
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis (OA) of 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 19 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
- NCT06964022
- Sponsor's protocol ID
- 2023_D
- Status last verified
- Apr 2025
- First submitted
- 30 Apr 2025
- Last updated
- 8 Sep 2026
- Results posted
- 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Blood-Flow-Restriction Prehabilitation on Pre- and Postoperative Rehabilitation After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06964022
- Acronym / sponsor ID
- 2023_D
- Conditions
- Osteoarthritis (OA) of the Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 9 May 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.
Degenerative and traumatic diseases of the musculoskeletal system lead to increased immobility of a patient, which in turn results in muscle atrophy. BFR training is a training method in which a blood pressure cuff partially blocks the arterial blood flow to the exercising limb and completely blocks the venous blood flow. During exercise, an externally induced venous occlusion occurs. This stimulus increases the metabolic stimulus in the occluded extremity - this means that strength can be increased even with low weights, which is why this training is also suitable for people who should not use high training loads due to injuries or operations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Control | Active comparator | Other: Sham-BFRParticipants of this group were active controls, exercising with a sham-BFR intervention during prehabilitation. |
| Intervention Group | Experimental | Other: BFRParticipants of this group were exercising with a BFR intervention during prehabilitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Indication for TKA Surgery
- Ability to perform prehabilitation exercise
Key exclusion criteria (3 listed)
- Sickle Cell Anemia
- Iatrogenic changes in the vessels of the lower extremities (e.g. stents)
- Open wounds/Infection of the lower extremities
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 |
|---|---|---|
| Sham-BFRSix-week prehabilitation program (2/week): Unilateral Leg Press and Leg extension exercise with 30% of the individual 1RM by using a sham-BFR intervention with 20mmHg exercise pressure. | Other | Active Control |
| BFRSix-week prehabilitation program (2/week): Unilateral Leg Press and Leg extension exercise with 30% of the individual 1RM by using a BFR intervention with an exercise pressure corresponding to 60% of the individual LOP. | Other | Intervention Group |
Primary outcome
Subjective Pain Value
Time frame: Pre- to 6 weeks Post Surgery
Subjective pain perception, assessed by visual analog scale (0-100mm)
Muscle Strength
Time frame: Pre- to 6 weeks Post Surgery
Muscle Strength assessed by isometric maximal test (Nm)
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 8 Sep 2026.
- 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 BFR in people with Osteoarthritis (OA) of 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 2 inclusion and 3 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 8 Sep 2026. 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. 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?
Subjective Pain Value (time frame: Pre- to 6 weeks Post Surgery). 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 8 Sep 2026.