The purpose of this study is to collect safety and performance data of the Photodynamic Bone Stabilization System (PBSS) when used for the treatment of painful impending and actual fractures of the humerus secondary to metastatic cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Treatment of impending and actual pathological fractures of the humerus
Medical University of Vienna
Vienna, Austria
St. Vinzenz-Hospital GmbH
Cologne, Germany
Johannes Wesling Klinikum Minden
Minden, Germany
Lahn-Dill Kliniken
Wetzlar, Germany
Pain Reduction
VAS Pain Score change of \> -33% compared to baseline. Visual Analog Scale (VAS) pain score is based on a 100 mm line. The subject places a mark on the line to indicate the level of pain. The scale goes from 0 (no pain) to 100 (worst imaginable pain). The distance on the line from zero to the mark indicates the score.
Time frame: 90 days
Functional Improvement - Barthel Index
Barthel Index of Activities of Daily Living (ADLs) improvement of \>= +10% from baseline. Total score ranges from 0 to 100 points (scores on a scale). Higher scores indicate greater independence and better functional outcome, while lower scores indicate greater dependence and worse functional outcome.
Time frame: 90 days
Pain Reduction
VAS Pain Score change of \>= -33% compared to baseline. Visual Analog Scale (VAS) pain score is based on a 100 mm line. The subject places a mark on the line to indicate the level of pain. The scale goes from 0 (no pain) to 100 (worst imaginable pain). The distance on the line from zero to the mark indicates the score.
Time frame: 180 and 360 days
Summary Percent Change From Baseline of Visual Analog Scale (VAS) Pain Score
Visual Analog Scale (VAS) pain score is based on a 100 mm line. The subject places a mark on the line to indicate the level of pain. The scale goes from 0 (no pain) to 100 (worst imaginable pain). The distance on the line from zero to the mark indicates the score.
Time frame: 90, 180, 360 days
Functional Improvement - Barthel Index
Barthel Index of Activities of Daily Living (ADLs) improvement of \>= +10% from baseline. Total score ranges from 0 to 100 points (scores on a scale). Higher scores indicate greater independence and better functional outcome, while lower scores indicate greater dependence and worse functional outcome.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Medisch Spectrum Twente
Enschede, Netherlands
Medical Center Leeuwarden
Leeuwarden, Netherlands
Time frame: 180 and 360 days
Change From Baseline of Barthel Index of Activities of Daily Living
Change from baseline in Barthel Index of Activities of Daily Living Score by visit. Scores for each scale and domain are transformed to range from 0 to 100 points (scores on a scale). Higher scores indicate better functional status and improved quality of life outcomes, while lower scores indicate worse functioning.
Time frame: 90, 180, 360 Days
Functional Improvement - EORTC QLQ-C30
Functional Improvement using EORTC QLQ-C30 improvement of \>= +10% from baseline. Scores for each scale and domain are transformed to range from 0 to 100 points (scores on a scale). Higher scores indicate better functional status and improved quality of life outcomes, while lower scores indicate worse functioning.
Time frame: 90, 180, 360 days
Functional Improvement - EORTC QLQ-BM22
Functional Improvement - EORTC QLQ-BM22 \>= 10% change from baseline. Scores for each scale and domain are transformed to range from 0 to 100 points (scores on a scale). Higher scores indicate better functional status and improved quality of life outcomes, while lower scores indicate worse functioning.
Time frame: 90, 180, 360 days
Surgical Interventions
Surgical interventions include revisions, supplements, fixations and removals
Time frame: 90, 180, 360 days
Device Status
Summary of device status (intact and in-place)
Time frame: 90, 180, 360 days
Serious Device-Related Complications
Summary of serious device-related complications
Time frame: 90, 180, 360 days