Clinical trial NCT06134167: A Study to Evaluate the Safety and Effectiveness Transdermal Compress Device in Participants with Transfemoral Amputations
Official title: A Prospective, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Effectiveness of the Transdermal Compress Device in Participants with Transfemoral Amputations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Prosthesis and Implants
Lead sponsor: Balmoral Medical company
Sponsor class: INDUSTRY
First posted: 2023-11-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of the Transdermal Compress device in participants with Transfemoral Amputations.

Detailed description: This study is a prospective, multicenter, single-arm, open-label study in skeletally mature participants with transfemoral limb loss (unilateral or bilateral), without bone or vascular disease who have or are anticipated to have rehabilitation problems with or cannot use a conventional socket prosthesis.

Study participants will undergo surgical implantation of the Transdermal Compress device on Study Day 1.

Participant progression including clinical assessments and prosthetic use will follow the study rehabilitation protocol.

Events of special interest include superficial and deep infections at the implant site, failures, and secondary surgical interventions; participants will be followed for all soft tissue interface issues.

Participants will be assessed for effectiveness and safety endpoints at baseline and at Months 6, 12, 18, and 24 and annually through 5 years post-implantation.

Adverse events and adverse device effects will be collected and reported starting at the time of surgical implantation.

Study participants will also be included in the Osseointegration Quality Registry in parallel to this study to allow for long-term follow-up post-study.

Eligibility criteria: Inclusion Criteria

1. Participant must be able to understand the investigational nature of this study and has reviewed and provided written, informed consent prior to any study-specific procedures.
2. Participant is a skeletally mature male or female and is 18 - 65 years of age at screening. Participants \< 22 years of age require radiographic confirmation of skeletal maturity and must have failed the use of conventional prosthesis.
3. Participant has an estimated BMI of ≥ 18.5 and ≤ 40 kg/m2 and weight ≤ 245 lbs without prosthesis.
4. Participant has unilateral or bilateral transfemoral limb loss without bone or vascular disease.
5. Participant has problems with conventional prostheses or is not able to use a prosthesis at all or is anticipated to experience problems with a socket prosthesis in the investigator's judgment.
6. Participant has adequate bone stock to support the implanted device
7. Participant does not have any cortical defect located between the expected location of the anchor plug and spindle/bone interface.
8. Participant has the willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study including the prescribed rehabilitation program.

Exclusion Criteria

1. Female participants who are pregnant, nursing, or have a planned pregnancy during the first 12 months post-surgical implantation.
2. Participant had a prior osseointegrated device implanted in the lower limb planned for the study device.
3. Participant has a history of systemic or localized infection at the residual limb site within 6 months prior to Study Day 1.
4. Participant has any distant foci of infections.
5. Participant has a history of sepsis within 6 months prior to Study Day 1.
6. Participant's length of the residual femur cannot accommodate the intramedullary portion of the Transdermal Compress device.
7. Participant has a femoral deformity that in the opinion of the treating surgeon results in an inability to properly insert the Transdermal Compress implant system, and/or results in alignment that is biomechanically unsound.
8. Participant does not have an adequate myofascial flap to allow for circumferential contact with the implanted device.
9. Participant has evidence of or history of severe peripheral vascular disease or insufficiency, muscular atrophy, neuromuscular disease, or diabetes mellitus (Type I or Type II).
10. Participant has evidence of or a documented history of osteomyelitis (excluding the history of osteomyelitis distal to amputation), systemic osteoporosis, or osteomalacia.
11. Participants with identified risk factors for osteoporosis must have a reported T-score \> -2.5 within 6 months prior to Study Day 1.
12. Participant has evidence of or a documented history of severe metabolic disorders that may impair bone formation.
13. Participant has a history of systemically administered corticosteroids or immunosuppressive or immunomodulatory therapy or chemotherapy drugs.
14. Participant has known drug or alcohol dependence currently or within the last year.
15. Participant is a smoker, nicotine, or tobacco user in any form or who has used nicotine or tobacco-containing products within the past 6 months prior to Study Day 1.
16. Participant has any other condition, which in the opinion of the Investigator, precludes the participant's participation in the study or the participant is unlikely to comply with the protocol-defined

Primary outcomes:
measure: The study primary endpoint is a composite endpoint to determine the proportion of participants who are successful on the primary effectiveness and safety endpoints (overall success) at 2 years
timeFrame: Two (2) years post-implantation
Secondary outcomes:
measure: Overall infection rate
timeFrame: Two (2) and Five (5) years post-implantation
measure: Lack of secondary surgical intervention
timeFrame: Two (2) and Five (5) years post-implantation
measure: Orthotics and Prosthetics Users Survey: Satisfaction with Devices
timeFrame: Two and Five (2-5) years post-implantation
measure: Prosthetic Wear Time
timeFrame: Two (2) and Five (5) years post-implantation
measure: Patient Reported Outcome Measurement Information System: Physical Function
timeFrame: Two (2) and Five (5) years post-implantation
measure: A composite endpoint will be evaluated to determine the proportion of participants who are successes on both the primary effectiveness and safety endpoints at 2 years and 5 years.
timeFrame: Two (2) and Five (5) years post-implantation
measure: The proportion of participants with no more than 2 superficial infections per year and no more than 3 superficial infections in the first two years post-implantation.
timeFrame: Two (2) years post-implantation
measure: The proportion of participants who have had serious device-related adverse events.
timeFrame: Two (2) and Five (5) years post-implantation
measure: Type and frequency of mechanical complications over time.
timeFrame: Two (2) and Five (5) years post-implantation
measure: Patient Reported Outcome Measurement Information System: Pain Intensity
timeFrame: Two (2) and Five (5) years post-implantation
measure: Patient Reported Outcome Measurement Information System: Pain Behavior
timeFrame: Two (2) and Five (5) years post-implantation
measure: Patient Reported Outcome Measurement Information System: Pain Interference
timeFrame: Two (2) and Five (5) years post-implantation
Other outcomes:
measure: Radiographic Outcomes
timeFrame: Two (2) and Five (5) years post-implantation
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Washington
country: United States
facility: Walter Reed Military Medical Center
state: District of Columbia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Philidelphia
country: United States
facility: Penn Medicine; University of Pennsylvania Health System
state: Pennsylvania
city: Pittsburg
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: Balmoral
name: David Recker, M.D.
role: STUDY_DIRECTOR
References: