RecruitingPhase 3

A Study to Evaluate the Safety and Effectiveness Transdermal Compress Device in Participants With Transfemoral Amputations

United States100 participantsStarted 2024-06-11

Plain-language summary

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

Who can participate

Age range18 Years – 60 Years

SexALL

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Inclusion criteria

✓. 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.
✓. 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.
✓. Participant has an estimated BMI of ≥ 18.5 and ≤ 40 kg/m2 and weight ≤ 245 lbs without prosthesis.
✓. Participant has unilateral or bilateral transfemoral limb loss without bone or vascular disease.
✓. 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.
✓. Participant has adequate bone stock to support the implanted device
✓. Participant does not have any cortical defect located between the expected location of the anchor plug and spindle/bone interface.
✓. 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

✕. Female participants who are pregnant, nursing, or have a planned pregnancy during the first 12 months post-surgical implantation.
✕. Participant had a prior osseointegrated device implanted in the lower limb planned for the study device.
✕. Participant has a history of systemic or localized infection at the residual limb site within 6 months prior to Study Day 1.
✕. Participant has any distant foci of infections.
✕. Participant has a history of sepsis within 6 months prior to Study Day 1.
✕. Participant's length of the residual femur cannot accommodate the intramedullary portion of the Transdermal Compress device.
✕. 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.
✕. Participant does not have an adequate myofascial flap to allow for circumferential contact with the implanted device.

What they're measuring

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

Trial details

NCT IDNCT06134167

SponsorBalmoral Medical company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2030-12

Contact for this trial

Mary Thacker

574-253-3353 mthacker@capstonedeservices.com, BAL-448-001@capstonedevservices.com

View on ClinicalTrials.gov More Prosthesis and Implants trials