Clinical trial NCT05825456: Metastatic Pathologic Fractures, Short Term Results
Official title: Metastatic Pathologic Fractures: Short Term Results of Endoprosthetic Reconstruction, Intramedullary Nail and Open Reduction Internal Fixation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pathologic Fracture
Bone Metastases
Metastatic Cancer
Keywords: bone metastasis
pathologic fracture
endoprosthetic reconstruction
intramedullary nailing
open reduction internal fixation
plate and screws
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population includes patients with metastatic pathologic fractures treated via endoprosthesis, intramedullay nail or plate \& screws.

Brief summary: This is a single center prospective study to compare the short term results of prosthesis, nail and plate-screw surgeries for metastatic pathologic fractures.

Detailed description: The most common bone tumor in elderly is metastatic bone tumors. With the prolonged life expectancy in cancer patients, the management of the metastases became an essential topic.

Pathological fractures should be examined and managed with a different perspective. They usually cannot be healed by conservative methods and require surgical intervention. The primary goals of surgical intervention are to relieve pain and mobilize the patient as soon as possible.

The aim of the study is to compare the short-term functional endoprosthetic recontruction, intramedullary nailing and open reduction internal fixation.

The primary tumor of the patient, applied chemotherapy and radiotherapy, Mirel risk score, Charlson comorbidity index, and PathFx 3.0 survival will be evaluated preoperatively.

The type of the operation will be decided at the multidisciplinary tumor council of ankara University.

Eligibility criteria: Inclusion Criteria:

* metastatic pathologic fracture
* operated via endoprosthesis, intramedullary nail or plate \& screws

Exclusion Criteria:

* primary bone tumor
* conservative management
* neuromuscular disease
* periprosthetic fractures
* less than 1 month follow up

Primary outcomes:
measure: Musculoskeletal Tumor Society (MSTS) score
timeFrame: Preoperative
measure: Musculoskeletal Tumor Society (MSTS) score
timeFrame: Postoperative 1st day
measure: Musculoskeletal Tumor Society (MSTS) score
timeFrame: Postoperative 1st week
measure: Musculoskeletal Tumor Society (MSTS) score
timeFrame: Postoperative 1st month
measure: Toronto Extremity Salvage Score (TESS)
timeFrame: Preoperative
measure: Toronto Extremity Salvage Score (TESS)
timeFrame: Postoperative 1st day
measure: Toronto Extremity Salvage Score (TESS)
timeFrame: Postoperative 1st week
measure: Toronto Extremity Salvage Score (TESS)
timeFrame: Postoperative 1st month
measure: Visual analog scale (VAS)
timeFrame: Preoperative
measure: Visual analog scale (VAS)
timeFrame: Postoperative 1st day
measure: Visual analog scale (VAS)
timeFrame: Postoperative 1st week
measure: Visual analog scale (VAS)
timeFrame: Postoperative 1st month
measure: Upper Extremity Functional Scale (UEFS)
timeFrame: Preoperative
measure: Upper Extremity Functional Scale (UEFS)
timeFrame: Postoperative 1st day
measure: Upper Extremity Functional Scale (UEFS)
timeFrame: Postoperative 1st week
measure: Upper Extremity Functional Scale (UEFS)
timeFrame: Postoperative 1st month
measure: Disabilities of Arm, Shoulder and Hand (DASH)
timeFrame: Preoperative
measure: Disabilities of Arm, Shoulder and Hand (DASH)
timeFrame: Postoperative 1st day
measure: Disabilities of Arm, Shoulder and Hand (DASH)
timeFrame: Postoperative 1st week
measure: Disabilities of Arm, Shoulder and Hand (DASH)
timeFrame: Postoperative 1st month
measure: Lower Extremity Functional Scale (LEFS)
timeFrame: Preoperative
measure: Lower Extremity Functional Scale (LEFS)
timeFrame: Postoperative 1st day
measure: Lower Extremity Functional Scale (LEFS)
timeFrame: Postoperative 1st week
measure: Lower Extremity Functional Scale (LEFS)
timeFrame: Postoperative 1st month
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Preoperative
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Postoperative 1st day
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Postoperative 1st week
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Postoperative 1st month
Secondary outcomes:
measure: Days at hospital after surgery
timeFrame: up to 1 month
measure: Survival
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty
state: Altindag
Study officials:
References: