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Tests treatment safety and results for Transtibial Amputee
Official title Feasibility Study Evaluating the Safety and Effectiveness of Magnetic Bead Tracking System When Used With a Bionic External Prosthesis
ClinicalTrials.gov ID: NCT07195461
What this study is testing
- What it's testing
- The investigation is an early feasibility study in up to 5 subjects, in which the primary objective is to capture preliminary safety and effectiveness information on the Magnetic Bead Tracking system.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 65
You may be able to join if
- Male or Female age 22-65 at the time of surgery.
- The patient must already have an existing unilateral or bilateral transtibial amputation requiring revision or a medical condition requiring...
- If the patient does not already have an amputation, the patient must have undergone independent consultation with a lower extremity surgical...
- The patient must have the ability to ambulate at variable cadence (an expected lower extremity prosthesis functional level of K3 or above, as...
- The patient must have adequate soft tissue bulk and muscle mass present in the operative limb to support appropriate wound healing.
You likely can't join if
- Patients with any active skin disease in the subject limb.
- Patients with severe comorbidity, atypical skeletal anatomy, or poor general physical/mental health that, in the opinion of the Investigator, will...
- Patients with the following concurrent diseases: active infection or dormant bacteria, metabolic bone disease and/or metastatic lesions in the...
- Patients weighing over 285 lbs. with the prosthesis, at time of screening.
- Patients for whom skeletal growth is not complete. Completed skeletal growth is defined through the finding of generally closed epiphyseal zones on...
- Patients with advanced atrophic muscle and/or compromised soft tissue coverage in the operative limb.
See the full eligibility criteria
Who can join
- Male or Female age 22-65 at the time of surgery.
- The patient must already have an existing unilateral or bilateral transtibial amputation requiring revision or a medical condition requiring performance of a unilateral or bilateral transtibial amputation.
- If the patient does not already have an amputation, the patient must have undergone independent consultation with a lower extremity surgical specialist to ensure they have exhausted all limb salvage options prior to...
- The patient must have the ability to ambulate at variable cadence (an expected lower extremity prosthesis functional level of K3 or above, as determined by a trained and certified prosthetist and confirmed by study...
- The patient must have adequate soft tissue bulk and muscle mass present in the operative limb to support appropriate wound healing.
- The patient must demonstrate volitional activation of the muscles into which magnet placement is intended.
- In the opinion of the investigator, the patient must likely be able to tolerate the pressure of a prosthetic socket during ambulation post-operatively.
- In the opinion of the investigator, the patient must have absence of any physical limitations, addictive diseases or underlying medical conditions that may preclude the patient from being a good study candidate.
- The patient must have willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study.
- The patient must have willingness and ability to provide informed consent to participate in the study.
What rules you out
- Patients with any active skin disease in the subject limb.
- Patients with severe comorbidity, atypical skeletal anatomy, or poor general physical/mental health that, in the opinion of the Investigator, will not allow the patients to be a good study candidate (i.e., other disease...
- Patients with the following concurrent diseases: active infection or dormant bacteria, metabolic bone disease and/or metastatic lesions in the residual tibia.
- Patients weighing over 285 lbs. with the prosthesis, at time of screening.
- Patients for whom skeletal growth is not complete. Completed skeletal growth is defined through the finding of generally closed epiphyseal zones on X-ray.
- Patients with advanced atrophic muscle and/or compromised soft tissue coverage in the operative limb.
- Patients with evidence of or a documented history of severe peripheral vascular disease, diabetes mellitus (type I or type II), skin diseases, neuropathy or neuropathic disease and severe phantom pain, or osteoporosis...
- Patient with a history of systemically administered corticosteroids, immune-suppressive therapy or chemotherapy drugs within six (6) months of implant surgery.
- Patients with a known need of future MRIs.
- Patients currently involved in another clinical study where that participation may conflict or interfere with the treatment, follow-up or results of this clinical study.
- Active smokers will be excluded from candidacy; those patients willing to undergo tobacco cessation will need to be completely abstinent from tobacco use for at least 6 weeks preoperatively.
- Women who are pregnant, lactating or planning a pregnancy during the first twelve (12) months of the post-surgical follow-up.
- Patient having an allergy to any component of the device.
- Patients with concurrent illness, disability or geographical residence that would hamper attendance at required study visits.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.