Minimally-invasive Stabilization of Pelvic Metastases With Photodynamic Nails: A Multi-center Prospective Study of Functional Outcome
M.D. Anderson Cancer Center
Summary
Determine whether patients exhibit early functional improvement after minimally-invasive placement of Illuminoss photodynamic nails for peri-acetabular pelvic metastasis at 3 months following procedure
Description
Primary Objectives 1\. Evaluate whether patients exhibit early functional improvement after minimally-invasive placement of Illuminoss photodynamic nails for peri-acetabular pelvic metastasis at 3 months following procedure Secondary Objectives 1. Evaluate whether the procedure relieves pain 2. Evaluate radiographic stability of the implant 3. Evaluate functional outcome at earlier time points (2 weeks or 6 weeks) and at 6 months and possibly later time points 4. Evaluate reoperation rate and complications
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have a histologically confirmed malignancy from prior biopsy of the primary tumor or a metastatic site. Patients with carcinoma, myeloma, and lymphoma may be included in the study. Patients should have metastatic involvement of the periacetabular region that is visible radiographically. Biopsy of acetabular disease is not required for this study. * Age ≥18 years (Illuminoss is approved only for skeletally mature patients) * Suitable candidate for general anesthesia * Ability to understand and the willingness to sign a written informed consent document. * Ab…
Interventions
- ProcedurePhotodynamic nails
stab incision is made at the entry site
Location
- MD Anderson Cancer CenterHouston, Texas