Humerus Fracture Metastatic Bone Disease
Conditions
Brief summary
This study will collect safety and performance data of the Photodynamic Bone Stabilization System (PBSS) when used for the treatment of fractures of the humerus secondary to metastatic cancer.
Detailed description
This is a prospective, multi-center, open label study to evaluate the Photodynamic Bone Stabilization System (PBSS) when used for the treatment of painful impending and actual fractures of the humerus secondary to metastatic malignancy.
Interventions
Treatment of impending and actual pathological fractures of the humerus
Sponsors
IlluminOss Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- General Inclusion Criteria 1. Skeletally mature adult males and females 18 years of age or older. 2. Impending or actual pathological fracture of the humerus, secondary to metastatic bone disease. 3. Females: neither pregnant nor intending to become pregnant during the course of the study, defined as: 1. Postmenopausal for at least 1 year OR 2. Documented oophorectomy or hysterectomy 3. Surgically sterile OR 4. If of childbearing potential, must be practicing double-barrier method of birth control, be willing to avoid pregnancy for the period of study participation and have a negative pregnancy test at screening 4. Patient, or his/her legally authorized representative, is able to understand and provide informed consent. 5. Willing and able to comply with post-operative treatment protocol and follow-up visit schedule. 6. VAS Pain Score \> 60mm on 100mm scale. -Impending Fracture-Specific Inclusion Criteria 7. Documented presence of at least one metastatic lesion of the humerus. 8. Mirels Criteria Score ≥ 8. (specific to the target humeral lesion and subject to minimum VAS score requirements) 9. Destruction of cortical bone at impending fracture site \> 50%. -Actual Fracture-Specific Inclusion Criteria 10. Fracture is closed, Gustilo Type I or II.
Exclusion criteria
\- General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain | Baseline and 90 days | Change in VAS score from baseline. VAS is measured on a scale range from 0-100mm with 0 (no pain) to 100 (worst imaginable pain). |
| Change in Function | Baseline and 90 days | Change in Revised Musculoskeletal Tumor Society Rating Scale for Upper Extremity (MSTS). MSTS score is a six-item scale. It ranges from 0 to 30. Higher score is associated with better function. Scores were divided by 30 and multiplied by 100 to facilitate interpretation. |
| Summary of Clinical Safety Success | Up to Day 7-14, Up to Day 30, Up to Day 90, Up to Day 180, Up to Day 360 | No serious device related complications, no additional surgical interventions, and no device fracture, migrations, mal-alignment or loss of reduction or fixation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MSTS Upper Extremity Functional Outcome | 90, 180, 360 days | Musculoskeletal Tumor Society Rating Scale for Upper Extremity (MSTS) Functional Outcome. MSTS score is a six-item scale. It ranges from 0 to 30. Higher score is associated with better function. Scores were divided by 30 and multiplied by 100 to facilitate interpretation. |
| Assessment of Post-Surgery Status | Surgery & Discharge, 7-14, 30, 90, 180, 360 days | Number and percent of subjects who receive physical therapy, supportive orthopedic device, or analgesic medication |
| Pain at Palpation | 90, 180 and 360 days | Pain on palpation and clinical significance |
| Summary of Change From Baseline Range of Motion by Visit and Test | Baseline, 90, 180 and 360 Days | Range of motions tests (abduction, extension, flexion, lateral rotation and medial rotation) for active range of motion and passive range of motion for the affected and unaffected arm. |
| Length of Hospital Stay | From day of procedure until the day of hospital discharge (up to 36 days) | Length of hospital stay (from day of procedure to day of discharge) |
| Summary of Procedure and Device-Related Complications Rate | up to day 90, up to day180 since day 90, up to 360 since day 180 | Procedure and device-related complications rate presented at follow-up visits |
| Duration of Index Procedure | 1 Day | Duration of index procedure (hours) |
| Activities of Daily Living Score Through All Follow-up Intervals | Baseline, 90, 180 and 360 days | Change from Baseline in Activities of Daily Living Score (EORTC QLQ BM22) for each of the four scales at follow-up visits. There are two symptom scales (painful sites and pain characteristics) and two functional scales (functional interface and psychosocial aspects). All scales will be transformed to range in score from 0 to 100. A high score for the symptom scales represented a high level of symptomatology or problems, while a high score for the functional scales represents a high level of functioning. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Photodynamic Bone Stabilization System (PBSS) The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone
IlluminOss® Photodynamic Bone Stabilization System (PBSS): Treatment of impending and actual pathological fractures of the humerus | 81 |
| Total | 81 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Death | 32 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Reason not captured above | 6 |
Baseline characteristics
| Characteristic | Photodynamic Bone Stabilization System (PBSS) |
|---|---|
| Actual Bone Fracture Characteristics - AO Classification 11-A1 | 1 Participants |
| Actual Bone Fracture Characteristics - AO Classification 11-A2 | 6 Participants |
| Actual Bone Fracture Characteristics - AO Classification 11-A3 | 5 Participants |
| Actual Bone Fracture Characteristics - AO Classification 12-A1 | 7 Participants |
| Actual Bone Fracture Characteristics - AO Classification 12-A2 | 12 Participants |
| Actual Bone Fracture Characteristics - AO Classification 12-A3 | 5 Participants |
| Actual Bone Fracture Characteristics - AO Classification 12-B1 | 3 Participants |
| Actual Bone Fracture Characteristics - AO Classification 12-B2 | 7 Participants |
| Actual Bone Fracture Characteristics - AO Classification 12-C3 | 1 Participants |
| Actual Bone Fracture Characteristics - AO Classification NA | 1 Participants |
| Actual Bone Fracture Characteristics - AO Classification Unknown | 1 Participants |
| Actual Bone Fracture Characteristics - Gustilo Grading of Soft Tissue Closed Fracture | 46 Participants |
| Actual Bone Fracture Characteristics - Gustilo Grading of Soft Tissue Type I | 3 Participants |
| Actual Bone Fracture Characteristics - Location Diaphyseal | 20 Participants |
| Actual Bone Fracture Characteristics - Location Distal | 4 Participants |
| Actual Bone Fracture Characteristics - Location Proximal | 25 Participants |
| Actual Bone Fracture Characteristics - Location of Target Fracture Left Humerus | 24 Participants |
| Actual Bone Fracture Characteristics - Location of Target Fracture Right Humerus | 25 Participants |
| Age, Continuous | 63.9 years STANDARD_DEVIATION 11.91 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 78 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Impending Bone Fracture Characteristics - Location Diaphyseal | 9 Participants |
| Impending Bone Fracture Characteristics - Location Distal | 1 Participants |
| Impending Bone Fracture Characteristics - Location Proximal | 22 Participants |
| Impending Bone Fracture Characteristics - Location of Target Fracture Left Humerus | 14 Participants |
| Impending Bone Fracture Characteristics - Location of Target Fracture Right Humerus | 18 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 68 Participants |
| Region of Enrollment United States | 81 Participants |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 32 / 81 |
| other Total, other adverse events | 49 / 81 |
| serious Total, serious adverse events | 58 / 81 |
Outcome results
Primary
Change in Function
Change in Revised Musculoskeletal Tumor Society Rating Scale for Upper Extremity (MSTS). MSTS score is a six-item scale. It ranges from 0 to 30. Higher score is associated with better function. Scores were divided by 30 and multiplied by 100 to facilitate interpretation.
Time frame: Baseline and 90 days
Population: Subjects who had 90 Day data
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Photodynamic Bone Stabilization System (PBSS) | Change in Function | 39.23 units on a scale | Standard Error 2.929 |
Primary
Change in Pain
Change in VAS score from baseline. VAS is measured on a scale range from 0-100mm with 0 (no pain) to 100 (worst imaginable pain).
Time frame: Baseline and 90 days
Population: Number of subjects who had a Day 90 visit
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Photodynamic Bone Stabilization System (PBSS) | Change in Pain | -52.7 units on a scale | Standard Error 3.62 |
Comparison: Null hypothesis: Mean improvement in VAS over 90 days \<= 53.8 (i.e. 80% of reference based on historical control data). The study was powered to 80% with 68 evaluable subjects, a standard deviation of 13.3 at each visit, a true mean improvement from baseline VAS across post-baseline visits of 57 and a within-patient correlation of VAS of 0.4. The historical control data comes from 4 selected articles (Gregory et al. 2011, Kim et al. 2011, Deschamps et al. 2012, and Pretell et al. 2010).p-value: 0.615Mixed Models Analysis
Primary
Summary of Clinical Safety Success
No serious device related complications, no additional surgical interventions, and no device fracture, migrations, mal-alignment or loss of reduction or fixation
Time frame: Up to Day 7-14, Up to Day 30, Up to Day 90, Up to Day 180, Up to Day 360
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Photodynamic Bone Stabilization System (PBSS) | Summary of Clinical Safety Success | Up to D180 : No additional surgical intervention | 77 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Clinical Safety Success | Up to D180 : No device fracture, migration | 70 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Clinical Safety Success | Up to D180 : Safety Success | 70 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Clinical Safety Success | Up to D7-14 : No serious dev rel complications | 81 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Clinical Safety Success | Up to D7-14 : No additional surgical intervention | 81 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Clinical Safety Success | Up to D7-14 : No device fracture, migration | 80 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Clinical Safety Success | Up to D7-14 : Safety Success | 80 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Clinical Safety Success | Up to D30 : No serious dev rel complications | 80 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Clinical Safety Success | Up to D30 : No additional surgical intervention | 80 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Clinical Safety Success | Up to D30 : No device fracture, migration | 78 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Clinical Safety Success | Up to D30 : Safety Success | 78 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Clinical Safety Success | Up to D90 : No serious dev rel complications | 78 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Clinical Safety Success | Up to D90 : No additional surgical intervention | 80 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Clinical Safety Success | Up to D90 : No device fracture, migration | 76 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Clinical Safety Success | Up to D90 : Safety Success | 75 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Clinical Safety Success | Up to D180 : No serious dev rel complications | 76 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Clinical Safety Success | Up to D360 : No serious dev rel complications | 74 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Clinical Safety Success | Up to D360 : No additional surgical intervention | 74 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Clinical Safety Success | Up to D360 : No device fracture, migration | 67 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Clinical Safety Success | Up to D360 : Safety Success | 67 Participants |
Comparison: 95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: Subjects who had no serious device related complications95% CI: [96, 100]
Comparison: 95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: No additional surgical interventions of revisions, supplements, fixations or removals95% CI: [96, 100]
Comparison: 95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation95% CI: [93, 100]
Comparison: 95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: Safety Success95% CI: [93, 100]
Comparison: 95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 7-14: Subjects who had no serious device related complications95% CI: [93, 100]
Comparison: 95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 30: No additional surgical interventions of revisions, supplements, fixations or removals95% CI: [93, 100]
Comparison: 95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 30: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation95% CI: [90, 99]
Comparison: 95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 30: Safety Success95% CI: [90, 99]
Comparison: 95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 90: Subjects who had no serious device related complications95% CI: [90, 99]
Comparison: 95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 90: No additional surgical interventions of revisions, supplements, fixations or removals95% CI: [93, 100]
Comparison: 95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 90: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation95% CI: [86, 98]
Comparison: 95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 90: Safety Success95% CI: [85, 97]
Comparison: 95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 180: Subjects who had no serious device related complications95% CI: [86, 98]
Comparison: 95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 180: No additional surgical interventions of revisions, supplements, fixations or removals95% CI: [88, 99]
Comparison: 95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 180: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation95% CI: [77, 93]
Comparison: 95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 180: Safety Success95% CI: [77, 93]
Comparison: 95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 360: Subjects who had no serious device related complications95% CI: [83, 96]
Comparison: 95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 360: No additional surgical interventions of revisions, supplements, fixations or removals95% CI: [83, 96]
Comparison: 95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 360: Subjects who had no device fracture, migration, mal-alignment or loss of reduction or fixation95% CI: [73, 90]
Comparison: 95% exact binomial confidence intervals provided for each of the parameters that make up the safety success endpoint and the safety success endpoint - Up to Day 360: Safety Success95% CI: [73, 90]
Secondary
Activities of Daily Living Score Through All Follow-up Intervals
Change from Baseline in Activities of Daily Living Score (EORTC QLQ BM22) for each of the four scales at follow-up visits. There are two symptom scales (painful sites and pain characteristics) and two functional scales (functional interface and psychosocial aspects). All scales will be transformed to range in score from 0 to 100. A high score for the symptom scales represented a high level of symptomatology or problems, while a high score for the functional scales represents a high level of functioning.
Time frame: Baseline, 90, 180 and 360 days
Population: Data is presented for subjects who had follow-up visit data. Subjects who withdrew from the study prior to a visit or did not come in for a visit are excluded from the analysis at that visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Photodynamic Bone Stabilization System (PBSS) | Activities of Daily Living Score Through All Follow-up Intervals | Functional Interference, 90 Day F/U | 30.41 units on a scale | Standard Deviation 29.362 |
| Photodynamic Bone Stabilization System (PBSS) | Activities of Daily Living Score Through All Follow-up Intervals | Functional Interference, 180 Day F/U | 28.86 units on a scale | Standard Deviation 33.357 |
| Photodynamic Bone Stabilization System (PBSS) | Activities of Daily Living Score Through All Follow-up Intervals | Functional Interference, 360 Day F/U | 35.12 units on a scale | Standard Deviation 31.625 |
| Photodynamic Bone Stabilization System (PBSS) | Activities of Daily Living Score Through All Follow-up Intervals | Psychosocial Aspects, 90 Day F/U | 12.73 units on a scale | Standard Deviation 22.316 |
| Photodynamic Bone Stabilization System (PBSS) | Activities of Daily Living Score Through All Follow-up Intervals | Psychosocial Aspects, 180 Day F/U | 12.48 units on a scale | Standard Deviation 25.522 |
| Photodynamic Bone Stabilization System (PBSS) | Activities of Daily Living Score Through All Follow-up Intervals | Psychosocial Aspects, 360 Day F/U | 16.36 units on a scale | Standard Deviation 26.056 |
| Photodynamic Bone Stabilization System (PBSS) | Activities of Daily Living Score Through All Follow-up Intervals | Painful Sites, 90 Day F/U | -6.55 units on a scale | Standard Deviation 17.093 |
| Photodynamic Bone Stabilization System (PBSS) | Activities of Daily Living Score Through All Follow-up Intervals | Painful Sites, 180 Day F/U | -5.56 units on a scale | Standard Deviation 17.029 |
| Photodynamic Bone Stabilization System (PBSS) | Activities of Daily Living Score Through All Follow-up Intervals | Painful Sites, 360 Day F/U | -5.19 units on a scale | Standard Deviation 18.248 |
| Photodynamic Bone Stabilization System (PBSS) | Activities of Daily Living Score Through All Follow-up Intervals | Pain Characteristics, 90 Day F/U | -32.12 units on a scale | Standard Deviation 29.988 |
| Photodynamic Bone Stabilization System (PBSS) | Activities of Daily Living Score Through All Follow-up Intervals | Pain Characteristics, 180 Day F/U | -28.94 units on a scale | Standard Deviation 33.115 |
| Photodynamic Bone Stabilization System (PBSS) | Activities of Daily Living Score Through All Follow-up Intervals | Pain Characteristics, 360 Day F/U | -37.35 units on a scale | Standard Deviation 32.655 |
Secondary
Assessment of Post-Surgery Status
Number and percent of subjects who receive physical therapy, supportive orthopedic device, or analgesic medication
Time frame: Surgery & Discharge, 7-14, 30, 90, 180, 360 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Photodynamic Bone Stabilization System (PBSS) | Assessment of Post-Surgery Status | Surgery/Discharge: Physical therapy prescribed | 27 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Assessment of Post-Surgery Status | Surgery/Discharge: Supportive orth dev recommend | 64 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Assessment of Post-Surgery Status | SurgeryDischarge: Analgesic med prescribed | 74 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Assessment of Post-Surgery Status | Surgery/Discharge: Completed physical therapy | NA Participants |
| Photodynamic Bone Stabilization System (PBSS) | Assessment of Post-Surgery Status | Surgery/Discharge: Used supportive orth devices | NA Participants |
| Photodynamic Bone Stabilization System (PBSS) | Assessment of Post-Surgery Status | Surgery/Discharge: Used analgesic medication | NA Participants |
| Photodynamic Bone Stabilization System (PBSS) | Assessment of Post-Surgery Status | 7-14 Day F/U: Physical therapy prescribed | 29 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Assessment of Post-Surgery Status | 7-14 Day F/U: Supportive orth dev recommend | 28 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Assessment of Post-Surgery Status | 7-14 Day F/U: Analgesic medication prescribed | 17 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Assessment of Post-Surgery Status | 7-14 Day F/U: Completed physical therapy | 26 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Assessment of Post-Surgery Status | 7-14 Day F/U: Used supportive orthopedic devices | 48 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Assessment of Post-Surgery Status | 7-14 Day F/U: Used analgesic medication | 64 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Assessment of Post-Surgery Status | 30 Day F/U: Physical therapy prescribed | 26 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Assessment of Post-Surgery Status | 30 Day F/U: Supportive orth recommend | 13 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Assessment of Post-Surgery Status | 30 Day F/U: Analgesic medication prescribed | 19 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Assessment of Post-Surgery Status | 30 Day F/U: Completed physical therapy | 32 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Assessment of Post-Surgery Status | 30 Day F/U: Used supportive orthopedic devices | 27 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Assessment of Post-Surgery Status | 30 Day F/U: Used analgesic medication | 51 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Assessment of Post-Surgery Status | 90 Day F/U: Physical therapy prescribed | 17 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Assessment of Post-Surgery Status | 90 Day F/U: Supportive orthopedic dev recommend | 6 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Assessment of Post-Surgery Status | 90 Day F/U: Analgesic medication prescribed | 8 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Assessment of Post-Surgery Status | 90 Day F/U: Completed physical therapy | 31 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Assessment of Post-Surgery Status | 90 Day F/U: Used supportive orthopedic devices | 11 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Assessment of Post-Surgery Status | 90 Day F/U : Used analgesic medication | 41 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Assessment of Post-Surgery Status | 180 Day F/U: Physical therapy prescribed | 12 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Assessment of Post-Surgery Status | 180 Day F/U: Supportive orth device recommend | 7 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Assessment of Post-Surgery Status | 360 Day F/U: Physical therapy prescribed | 2 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Assessment of Post-Surgery Status | 180 Day F/U: Analgesic medication prescribed | 6 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Assessment of Post-Surgery Status | 180 Day F/U: Completed physical therapy | 23 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Assessment of Post-Surgery Status | 180 Day F/U: Used supportive orthopedic devices | 4 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Assessment of Post-Surgery Status | 180 Day F/U: Used analgesic medication | 33 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Assessment of Post-Surgery Status | 360 Day F/U: Supportive orth device recommended | 2 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Assessment of Post-Surgery Status | 360 Day F/U: Analgesic medication prescribed | 2 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Assessment of Post-Surgery Status | 360 Day F/U: Completed physical therapy | 8 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Assessment of Post-Surgery Status | 360 Day F/U: Used supportive orthopedic devices | 2 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Assessment of Post-Surgery Status | 360 Day F/U: Used analgesic medication | 28 Participants |
Secondary
Duration of Index Procedure
Duration of index procedure (hours)
Time frame: 1 Day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Photodynamic Bone Stabilization System (PBSS) | Duration of Index Procedure | 1.64 hours | Standard Deviation 1.221 |
Secondary
Length of Hospital Stay
Length of hospital stay (from day of procedure to day of discharge)
Time frame: From day of procedure until the day of hospital discharge (up to 36 days)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Photodynamic Bone Stabilization System (PBSS) | Length of Hospital Stay | 5.1 Days | Standard Deviation 6.14 |
Secondary
MSTS Upper Extremity Functional Outcome
Musculoskeletal Tumor Society Rating Scale for Upper Extremity (MSTS) Functional Outcome. MSTS score is a six-item scale. It ranges from 0 to 30. Higher score is associated with better function. Scores were divided by 30 and multiplied by 100 to facilitate interpretation.
Time frame: 90, 180, 360 days
Population: Data is presented for subjects who had follow-up visit data. Subjects who withdrew from the study prior to a visit or did not come in for a visit are excluded from the analysis at that visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Photodynamic Bone Stabilization System (PBSS) | MSTS Upper Extremity Functional Outcome | 90 Day F/U | 40.13 units on a scale | Standard Deviation 23.607 |
| Photodynamic Bone Stabilization System (PBSS) | MSTS Upper Extremity Functional Outcome | 180 Day F/U | 44.15 units on a scale | Standard Deviation 26.507 |
| Photodynamic Bone Stabilization System (PBSS) | MSTS Upper Extremity Functional Outcome | 360 Day F/U | 54.75 units on a scale | Standard Deviation 22.608 |
Secondary
Pain at Palpation
Pain on palpation and clinical significance
Time frame: 90, 180 and 360 days
Population: Data is presented for subjects who had follow-up visit data. Subjects who withdrew from the study prior to a visit or did not come in for a visit are excluded from the analysis at that visit.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Photodynamic Bone Stabilization System (PBSS) | Pain at Palpation | 90 Day F/U | Pain on palpation Yes Clinically Si | 4 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Pain at Palpation | 90 Day F/U | Pain on palpation Yes Not Clinically Sig | 7 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Pain at Palpation | 90 Day F/U | Pain on palpation No | 42 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Pain at Palpation | 90 Day F/U | Pain on palpation Not Done | 1 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Pain at Palpation | 180 Day F/U | Pain on palpation Yes Clinically Si | 8 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Pain at Palpation | 180 Day F/U | Pain on palpation Yes Not Clinically Sig | 12 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Pain at Palpation | 180 Day F/U | Pain on palpation No | 25 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Pain at Palpation | 180 Day F/U | Pain on palpation Not Done | 4 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Pain at Palpation | 360 Day F/U | Pain on palpation Yes Clinically Si | 3 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Pain at Palpation | 360 Day F/U | Pain on palpation Yes Not Clinically Sig | 4 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Pain at Palpation | 360 Day F/U | Pain on palpation No | 27 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Pain at Palpation | 360 Day F/U | Pain on palpation Not Done | 2 Participants |
Secondary
Summary of Change From Baseline Range of Motion by Visit and Test
Range of motions tests (abduction, extension, flexion, lateral rotation and medial rotation) for active range of motion and passive range of motion for the affected and unaffected arm.
Time frame: Baseline, 90, 180 and 360 Days
Population: Data is presented for subjects who had follow-up visit data. Subjects who withdrew from the study prior to a visit or did not come in for a visit are excluded from the analysis at that visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 90 Day F/U, Med Rotate, Passive ROM unaffected arm | 2.89 degrees | Standard Deviation 20.939 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 180 Day F/U, Med Rotate, Active ROM unaffected arm | -1.3 degrees | Standard Deviation 14.72 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 90 Day F/U, Abduction, Active ROM affected arm | 31.3 degrees | Standard Deviation 33.36 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 90 Day F/U, Abduction, Passive ROM affected arm | 29.1 degrees | Standard Deviation 38.22 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 180 Day F/U, Abduction, Active ROM affected arm | 41.0 degrees | Standard Deviation 36.04 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 180 Day F/U Abduction, Passive ROM affected arm | 31.2 degrees | Standard Deviation 37.71 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 360 Day F/U, Abduction, Active ROM affected arm | 54.9 degrees | Standard Deviation 44.42 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 360 Day F/U, Abduction, Passive ROM affected arm | 46.3 degrees | Standard Deviation 51.24 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 90 Day F/U, Abduction, Active ROM unaffected arm | 2 degrees | Standard Deviation 32.14 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 90 Day F/U, Abduction, Pass ROM unaffected arm | -0.5 degrees | Standard Deviation 29.19 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 180 Day F/U, Abduction, Active ROM unaffected arm | 4.9 degrees | Standard Deviation 33.29 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 180 Day F/U, Abduction, Passive ROM unaffected arm | 6.0 degrees | Standard Deviation 32.46 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 360 Day F/U, Abduction, Active ROM unaffected arm | 19.1 degrees | Standard Deviation 43.62 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 360 Day F/U, Abduction, Passive ROM unaffected arm | 16.0 degrees | Standard Deviation 42.13 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 90 Day F/U, Extension, Active ROM affected arm | 12 degrees | Standard Deviation 14.88 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 90 Day F/U, Extension, Passive ROM affected arm | 11.7 degrees | Standard Deviation 17.01 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 180 Day F/U, Extension, Active ROM affected arm | 8.1 degrees | Standard Deviation 16.17 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 180 Day F/U, Extension, Passive ROM affected arm | 4.8 degrees | Standard Deviation 17.15 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 360 Day F/U, Extension, Active ROM affected arm | 10.3 degrees | Standard Deviation 19.75 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 360 Day F/U, Extension, Passive ROM affected arm | 7.7 degrees | Standard Deviation 21.83 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 90 Day F/U, Extension, Active ROM unaffected arm | 0.6 degrees | Standard Deviation 13.87 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 90 Day F/U, Extension, Passive ROM unaffected arm | -1.0 degrees | Standard Deviation 14.12 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 180 Day F/U, Extension, Active ROM unaffected arm | -4.1 degrees | Standard Deviation 17.96 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 180 Day F/U, Extension, Passive ROM unaffected arm | -4.1 degrees | Standard Deviation 17.41 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 360 Day F/U, Extension, Active ROM unaffected arm | 3.5 degrees | Standard Deviation 19.9 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 360 Day F/U, Extension, Passive ROM unaffected arm | 5.5 degrees | Standard Deviation 27.24 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 90 Day F/U, Flexion, Active ROM affected arm | 28.7 degrees | Standard Deviation 36.61 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 90 Day F/U, Flexion, Passive ROM affected arm | 28.5 degrees | Standard Deviation 45.27 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 180 Day F/U, Flexion, Active ROM affected arm | 33.1 degrees | Standard Deviation 39.9 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 180 Day F/U, Flexion, Passive ROM affected arm | 29.4 degrees | Standard Deviation 45.35 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 360 Day F/U, Flexion, Active ROM affected arm | 46.6 degrees | Standard Deviation 51.17 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 360 Day F/U, Flexion, Passive ROM affected arm | 36.7 degrees | Standard Deviation 52.28 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 90 Day F/U, Flexion, Active ROM unaffected arm | 5.6 degrees | Standard Deviation 29.85 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 90 Day F/U, Flexion, Passive ROM unaffected arm | 3.7 degrees | Standard Deviation 29.02 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 180 Day F/U, Flexion, Active ROM unaffected arm | 3.0 degrees | Standard Deviation 35.86 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 180 Day F/U, Flexion, Passive ROM unaffected arm | 1.8 degrees | Standard Deviation 34.72 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 360 Day F/U, Flexion, Active ROM unaffected arm | 7.5 degrees | Standard Deviation 42.01 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 360 Day F/U, Flexion, Passive ROM unaffected arm | 4.7 degrees | Standard Deviation 41.5 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 90 Day F/U, Lat Rotate, Active ROM affected arm | 10.4 degrees | Standard Deviation 22.51 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 90 Day F/U, Lat Rotate, Passive ROM affected arm | 8.6 degrees | Standard Deviation 23.61 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 180 Day F/U, Lat Rotate, Active ROM affected arm | 12.4 degrees | Standard Deviation 31.38 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 180 Day F/U, Lat Rotate, Passive ROM affected arm | 6.5 degrees | Standard Deviation 30.69 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 360 Day F/U, Lat Rotate, Active ROM affected arm | 16.6 degrees | Standard Deviation 22.79 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 360 Day F/U, Lat Rotate, Passive ROM affected arm | 13.6 degrees | Standard Deviation 20.99 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 90 Day F/U, Lat Rotate, Active ROM unaffected arm | 0.5 degrees | Standard Deviation 14.95 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 90 Day F/U, Lat Rotate, Passive ROM unaffected arm | 0.3 degrees | Standard Deviation 14.18 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 180 Day F/U, Lat Rotate, Active ROM unaffected arm | -3.6 degrees | Standard Deviation 18.67 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 180 Day F/U, Lat Rotate, Passive ROM unaffect arm | -6.0 degrees | Standard Deviation 19.14 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 360 Day F/U, Lat Rotate, Active ROM unaffected arm | 1.8 degrees | Standard Deviation 20.25 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 360 Day F/U, Lat Rotate, Passive ROM unaffect arm | -0.22 degrees | Standard Deviation 25.656 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 90 Day F/U, Med Rotate, Active ROM affected arm | 11.7 degrees | Standard Deviation 28.78 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 90 Day F/U, Med Rotate, Passive ROM affected arm | 7.5 degrees | Standard Deviation 25.9 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 180 Day F/U, Med Rotate, Active ROM affected arm | 2.2 degrees | Standard Deviation 31.21 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 180 Day F/U, Med Rotate, Passive ROM affected arm | 3.1 degrees | Standard Deviation 34.14 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 360 Day F/U, Med Rotate, Active ROM affected arm | 6.4 degrees | Standard Deviation 27.46 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 360 Day F/U, Med Rotate, Passive ROM affected arm | 6.3 degrees | Standard Deviation 24.28 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 90 Day F/U, Med Rotate, Active ROM unaffected arm | 1.7 degrees | Standard Deviation 14.43 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 180 Day F/U, Med Rotate, Passive ROM unaffect arm | 0.8 degrees | Standard Deviation 9.85 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 360 Day F/U, Med Rotate, Active ROM unaffected arm | 2.6 degrees | Standard Deviation 19.15 |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Change From Baseline Range of Motion by Visit and Test | 360 Day F/U, Med Rotate, Passive ROM unaffect arm | 2.5 degrees | Standard Deviation 18.76 |
Secondary
Summary of Procedure and Device-Related Complications Rate
Procedure and device-related complications rate presented at follow-up visits
Time frame: up to day 90, up to day180 since day 90, up to 360 since day 180
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Photodynamic Bone Stabilization System (PBSS) | Summary of Procedure and Device-Related Complications Rate | Procedure & device-related complications up to D90 | During device preparation | 0 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Procedure and Device-Related Complications Rate | Procedure & device-related complications up to D90 | During device implantation | 1 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Procedure and Device-Related Complications Rate | Procedure & device-related complications up to D90 | Post-implantation | 3 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Procedure and Device-Related Complications Rate | Procedure & device-related complications up to D90 | None | 77 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Procedure and Device-Related Complications Rate | Proc & dev-related comp rate up D180 since D90 | During device preparation | NA Participants |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Procedure and Device-Related Complications Rate | Proc & dev-related comp rate up D180 since D90 | During device implantation | NA Participants |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Procedure and Device-Related Complications Rate | Proc & dev-related comp rate up D180 since D90 | Post-implantation | 6 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Procedure and Device-Related Complications Rate | Proc & dev-related comp rate up D180 since D90 | None | 75 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Procedure and Device-Related Complications Rate | Proc & dev-related comp rate up to D360 since D180 | During device preparation | NA Participants |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Procedure and Device-Related Complications Rate | Proc & dev-related comp rate up to D360 since D180 | During device implantation | NA Participants |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Procedure and Device-Related Complications Rate | Proc & dev-related comp rate up to D360 since D180 | Post-implantation | 4 Participants |
| Photodynamic Bone Stabilization System (PBSS) | Summary of Procedure and Device-Related Complications Rate | Proc & dev-related comp rate up to D360 since D180 | None | 77 Participants |