Prosthesis and Implants
Conditions
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.
Interventions
DEVICETransdermal Compress Device
Study participants will undergo surgical implantation of the Transdermal Compress device on Study Day 1. Participants will be followed through the end of the study as they complete rehabilitation.
Sponsors
Balmoral Medical company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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 - 60 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Two (2) years post-implantation | The following endpoint components will be used to assess effectiveness in the composite endpoint: Prosthetic Wear Time PROMIS Physical Function OPUS Satisfaction with Devices and Services The following will be used to assess safety in the composite endpoint: Lack of secondary surgical intervention. No more than 2 superficial infections per year and no more than 3 superficial infections in the first two years post-implantation. Radiographic success. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall infection rate | Two (2) and Five (5) years post-implantation | Overall infection rate subclassified as deep or superficial to the fascia. |
| Lack of secondary surgical intervention | Two (2) and Five (5) years post-implantation | Lack of secondary surgical intervention |
| Orthotics and Prosthetics Users Survey: Satisfaction with Devices | Two and Five (2-5) years post-implantation | 21-item scale that measures satisfaction with the prosthetic device and care quality. Items are rated on 5 points (1 = Strongly agree to 5 = Strongly Disagree). |
| Prosthetic Wear Time | Two (2) and Five (5) years post-implantation | Prosthetic Wear Time- Hours per Day. |
| Patient Reported Outcome Measurement Information System: Physical Function | Two (2) and Five (5) years post-implantation | Clinical outcome assessment (COA) that measures the patient's experience with the use of a transdermal device in that the primary goal is to improve physical function.: Physical Function. Items on are rated on 5 points (1 = unable to do. 5 = Without any difficulty). |
| 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. | Two (2) and Five (5) years post-implantation | The following endpoint components will be used to assess effectiveness in the composite endpoint: Prosthetic Wear Time Patient Reported Outcome Measurement Information System: Physical Function Orthotics and Prosthetics Users Survey: Satisfaction with Devices |
| 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. | Two (2) years post-implantation | 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. |
| The proportion of participants who have had serious device-related adverse events. | Two (2) and Five (5) years post-implantation | The proportion of participants who have had serious device-related adverse events. |
| Type and frequency of mechanical complications over time. | Two (2) and Five (5) years post-implantation | Any mechanical complications will be recorded and evaluated for device deficiencies. |
| Patient Reported Outcome Measurement Information System: Pain Intensity | Two (2) and Five (5) years post-implantation | Pain Intensity domain measures self-reported pain on a scale of 0 (No Pain) to 10 (Worst imaginable pain). |
| Patient Reported Outcome Measurement Information System: Pain Behavior | Two (2) and Five (5) years post-implantation | Measures self-reported external manifestations of pain: behaviors that typically indicate to others that an individual is experiencing pain. |
| Patient Reported Outcome Measurement Information System: Pain Interference | Two (2) and Five (5) years post-implantation | They include observable displays (sighing, crying), pain severity behaviors (resting, guarding, facial expressions, and asking for help), and verbal reports of pain. The scale contains 7-question rating to evaluate pain behavior on a 6 point scale (1 = Had no pain, 6 = Always have pain |
Countries
United States
Contacts
CONTACTMary Thacker
STUDY_DIRECTORDavid Recker, M.D.
Balmoral
Outcome results
None listed