Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05825456

Metastatic Pathologic Fractures, Short Term Results

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Pathologic Fracture Bone Metastases Fractures, Bone Fractures, Spontaneous Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara University Medical Faculty

Ankara, altindag, 06230, Turkey (Türkiye)

Location status: Recruiting

Location contact

Merve Dursun Savran, MD

CONTACT

[email protected]

00905395571557

Merve Dursun Savran, MD

SUB_INVESTIGATOR

Mustafa Onur Karaca, Assc. Proff

CONTACT

[email protected]

00905324812113

Mustafa Onur Karaca, Assc. Proff

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

endoprosthetic reconstruction

Procedure

This is a type of surgery in which the affected part of the bone and joint is removed, and replaced by a prosthesis.

intramedullary nailing

Procedure

This is a type of surgery in which the affected bone is stabilized by a nail. The affected part could be removed or retained. If removed, the defect is filled with bone cement.

Open reduction internal fixation with plate and screws

Procedure

This is a type of surgery in which the affected part of the bone is visualized completely, after the reduction is achieved, the fixation is provided with appropriate plates and screws. Again the affected part could be removed or retained. If removed, the defect is filled with bone cement.

Primary outcomes

  1. Musculoskeletal Tumor Society (MSTS) score

    Time frame: Preoperative

    MSTS score is for evaluating the patients with bone tumors. It consists of six domains; scored on a 0 to 5 scale and transformed into an overall score ranging from 0 to 100% with a higher score indicating better function.

  2. Musculoskeletal Tumor Society (MSTS) score

    Time frame: Postoperative 1st day

    MSTS score is for evaluating the patients with bone tumors. It consists of six domains; scored on a 0 to 5 scale and transformed into an overall score ranging from 0 to 100% with a higher score indicating better function.

  3. Musculoskeletal Tumor Society (MSTS) score

    Time frame: Postoperative 1st week

    MSTS score is for evaluating the patients with bone tumors. It consists of six domains; scored on a 0 to 5 scale and transformed into an overall score ranging from 0 to 100% with a higher score indicating better function.

  4. Musculoskeletal Tumor Society (MSTS) score

    Time frame: Postoperative 1st month

    MSTS score is for evaluating the patients with bone tumors. It consists of six domains; scored on a 0 to 5 scale and transformed into an overall score ranging from 0 to 100% with a higher score indicating better function.

  5. Toronto Extremity Salvage Score (TESS)

    Time frame: Preoperative

    TESS is widely used for the functional assessment of patients following surgery for musculoskeletal tumours. In the TESS system, specific movements for independent living and functionality are questioned and scored.While the worst score is 0, the best score for the lower extremity is 150, and the best score for the upper extremity is 145.

  6. Toronto Extremity Salvage Score (TESS)

    Time frame: Postoperative 1st day

    TESS is widely used for the functional assessment of patients following surgery for musculoskeletal tumours. In the TESS system, specific movements for independent living and functionality are questioned and scored.While the worst score is 0, the best score for the lower extremity is 150, and the best score for the upper extremity is 145.

  7. Toronto Extremity Salvage Score (TESS)

    Time frame: Postoperative 1st week

    TESS is widely used for the functional assessment of patients following surgery for musculoskeletal tumours. In the TESS system, specific movements for independent living and functionality are questioned and scored.While the worst score is 0, the best score for the lower extremity is 150, and the best score for the upper extremity is 145.

  8. Toronto Extremity Salvage Score (TESS)

    Time frame: Postoperative 1st month

    TESS is widely used for the functional assessment of patients following surgery for musculoskeletal tumours. In the TESS system, specific movements for independent living and functionality are questioned and scored.While the worst score is 0, the best score for the lower extremity is 150, and the best score for the upper extremity is 145.

  9. Visual analog scale (VAS)

    Time frame: Preoperative

    VAS is a widely used scale for pain. 0 means no pain where 10 means unbearable pain.

  10. Visual analog scale (VAS)

    Time frame: Postoperative 1st day

    VAS is a widely used scale for pain. 0 means no pain where 10 means unbearable pain.

  11. Visual analog scale (VAS)

    Time frame: Postoperative 1st week

    VAS is a widely used scale for pain. 0 means no pain where 10 means unbearable pain.

  12. Visual analog scale (VAS)

    Time frame: Postoperative 1st month

    VAS is a widely used scale for pain. 0 means no pain where 10 means unbearable pain.

  13. Upper Extremity Functional Scale (UEFS)

    Time frame: Preoperative

    UEFS is a functional scale for upper extremity. It is not specific for tumor patients.

  14. Upper Extremity Functional Scale (UEFS)

    Time frame: Postoperative 1st day

    UEFS is a functional scale for upper extremity. It is not specific for tumor patients.

  15. Upper Extremity Functional Scale (UEFS)

    Time frame: Postoperative 1st week

    UEFS is a functional scale for upper extremity. It is not specific for tumor patients.

  16. Upper Extremity Functional Scale (UEFS)

    Time frame: Postoperative 1st month

    UEFS is a functional scale for upper extremity. It is not specific for tumor patients.

  17. Disabilities of Arm, Shoulder and Hand (DASH)

    Time frame: Preoperative

    DASH is a widely used functional scale for upper extremity. It is not specific for tumor patients.

  18. Disabilities of Arm, Shoulder and Hand (DASH)

    Time frame: Postoperative 1st day

    DASH is a widely used functional scale for upper extremity. It is not specific for tumor patients.

  19. Disabilities of Arm, Shoulder and Hand (DASH)

    Time frame: Postoperative 1st week

    DASH is a widely used functional scale for upper extremity. It is not specific for tumor patients.

  20. Disabilities of Arm, Shoulder and Hand (DASH)

    Time frame: Postoperative 1st month

    DASH is a widely used functional scale for upper extremity. It is not specific for tumor patients.

  21. Lower Extremity Functional Scale (LEFS)

    Time frame: Preoperative

    LEFS is a functional scale for lower extremity. It is not specific for tumor patients.

  22. Lower Extremity Functional Scale (LEFS)

    Time frame: Postoperative 1st day

    LEFS is a functional scale for lower extremity. It is not specific for tumor patients.

  23. Lower Extremity Functional Scale (LEFS)

    Time frame: Postoperative 1st week

    LEFS is a functional scale for lower extremity. It is not specific for tumor patients.

  24. Lower Extremity Functional Scale (LEFS)

    Time frame: Postoperative 1st month

    LEFS is a functional scale for lower extremity. It is not specific for tumor patients.

  25. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: Preoperative

    WOMAC is a widely used functional scale for lower extremity. It is not specific for tumor patients.

  26. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: Postoperative 1st day

    WOMAC is a widely used functional scale for lower extremity. It is not specific for tumor patients.

  27. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: Postoperative 1st week

    WOMAC is a widely used functional scale for lower extremity. It is not specific for tumor patients.

  28. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: Postoperative 1st month

    WOMAC is a widely used functional scale for lower extremity. It is not specific for tumor patients.

Secondary outcomes

  1. Days at hospital after surgery

    Time frame: up to 1 month

    Hospitalization length required after the surgery.

  2. Survival

    Time frame: up to 3 months

    Time that the patient lives after the surgery

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

Metastatic Pathologic Fractures: Short Term Results of Endoprosthetic Reconstruction, Intramedullary Nail and Open Reduction Internal Fixation

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 24, 2023
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.