B-FREE for Knee Injuries

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Michigan Technological University, Houghton, MI
Knee Injuries+3 More
B-FREE - Other
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether blood flow restriction exercise may help individuals with quadriceps weakness following a total knee replacement.

See full description

Eligible Conditions

  • Knee Injuries
  • Arthritis of the Knee Joint
  • Osteoarthritis of the Knee

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether B-FREE will improve 2 primary outcomes and 2 secondary outcomes in patients with Knee Injuries. Measurement will happen over the course of Change from baseline at 10 weeks.

Week 10
Change in Balance
Change in Muscle size
Change in Muscle strength
Change in Walking performance

Trial Safety

Trial Design

2 Treatment Groups

Healthy Controls Only
1 of 2
Adults with TKR Perform Home Exercise Program
1 of 2
Active Control
Experimental Treatment

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. B-FREE is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Adults with TKR Perform Home Exercise Program
Other
Participants that have a total knee replacement will complete a home-based exercise program
Healthy Controls OnlyParticipants that have no history of knee joint dysfunction will serve as age-matched uninjured controls

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline at 10 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly change from baseline at 10 weeks for reporting.

Closest Location

Michigan Technological University - Houghton, MI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Ages 40-75 are generally considered the best years of life. show original
Participants in Arm 1 had unilateral total knee arthroplasty > 6 months prior to study participation. show original
The subject has no history of knee injury or surgery. show original

Patient Q&A Section

Can knee injuries be cured?

"This treatment approach and the results confirm that there is an important role for physical therapists in the clinical management of knee injuries. The positive outcomes are further supported by research demonstrating the value of this approach to rehabilitation." - Anonymous Online Contributor

Unverified Answer

What is knee injuries?

"The knee represents a typical musculoskeletal trauma for both males and females. Osteochondritis has a higher incidence in females than in males as does an ACL tear. An ACL reconstruction represents a significant burden on all systems. The treatment of osteochondritis is complex. There is a need for development of new implants and surgical techniques." - Anonymous Online Contributor

Unverified Answer

How many people get knee injuries a year in the United States?

"The number of knee injuries per year has decreased markedly in the last two decades despite increasing ages of participants. These trends suggest that certain interventions are having a positive impact on knee injuries." - Anonymous Online Contributor

Unverified Answer

What are common treatments for knee injuries?

"Knee sprains are common among young children; the majority of injuries are minor. Most will subside without surgery within two weeks and only about 20% require a doctor's attention." - Anonymous Online Contributor

Unverified Answer

What are the signs of knee injuries?

"The history and physical examination play a major role in the evaluation of knee injuries. The physical exam is crucial in determining the severity of injuries. It should also exclude any potential bony fracture (open kneecap or locked joint with abnormal pain) that may need immediate surgical fixation. A CT scan is suggested even for mild and moderate knee injuries. There is no need to do a magnetic resonance imaging (MRI) in such cases. The use of MRI should be reserved for patients with severe or occult injuries. In very rare cases (e.g. fractures of the tibia or patella), it can be used." - Anonymous Online Contributor

Unverified Answer

What causes knee injuries?

"Injuries occurring in sporting/non-sporting activities differed substantially. Institutional and interpersonal and environmental characteristics play an important role in this and are relevant to designing preventive strategies." - Anonymous Online Contributor

Unverified Answer

Has b-free proven to be more effective than a placebo?

"The benefits from B supplementation seem to be mainly related to the use of high-dose B, rather than to the effect of B itself, with high-dose B being better than placebo in decreasing knee pain." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for knee injuries?

"A large sample of patients with knee injuries is needed to ensure detection of important difference between groups. The type of treatment the primary care physicians use to help guide referral to an OTA clinic needs to be ascertained before enrollment in an OTA trial." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating knee injuries?

"There have been numerous new discoveries for treating knee injuries since the last CME for treatment methods of injury and rehabilitation. A review was undertaken on a literature search of all articles reporting treatments of knee injuries published in the last 5 years on PubMed to determine whether the methodology and clinical outcome of treatment methods have improved since these last CME's. Based on the information presented here, the treatment methods have clearly improved over the last 5 years." - Anonymous Online Contributor

Unverified Answer

What does b-free usually treat?

"B-free is a well-received and effective product for the treatment of many chronic conditions; however, to avoid wasting money and resources it is important to use it appropriately and correctly. According to the results of the study B-free did not meet the requirements of a drug that could be considered as an effective and safe treatment in patients suffering from chronic low [back pain](https://www.withpower.com/clinical-trials/back-pain) in combination with other pain medications and that could be used in the management of other chronic conditions." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in b-free for therapeutic use?

"The data imply that further work of this kind is needed. For example, data are presently lacking and it is not possible to draw conclusions regarding the benefits of the MALDI-TOF technique in relation to other methods such as PCR and conventional MALDI-TOF systems. To make an indication of the latest developments, the findings of the study of Brouwers et al. are discussed." - Anonymous Online Contributor

Unverified Answer

What is the latest research for knee injuries?

"The knee has been a subject of significant research since the 1800s, when physiologist Victor Horsley published his landmark paper on the study of the muscle pump. During the following decades, many advancements in knee surgery have occurred, including innovations in ACL repair, meniscal repair, and joint replacements. Although surgeons, athletes, and families can pursue advances in these surgical techniques, the best way to minimize the risk of knee injury is by preventing all injuries through proper body mechanics and strength training." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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