NCT05825456

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

March 5, 2025

Status Verified

March 1, 2025

Enrollment Period

4 years

First QC Date

March 26, 2023

Last Update Submit

March 1, 2025

Conditions

Pathologic FractureBone MetastasesMetastatic Cancer

Keywords

bone metastasispathologic fractureendoprosthetic reconstructionintramedullary nailingopen reduction internal fixationplate and screws

Outcome Measures

Primary Outcomes (28)

  • Musculoskeletal Tumor Society (MSTS) score

    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.

    Preoperative

  • Musculoskeletal Tumor Society (MSTS) score

    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.

    Postoperative 1st day

  • Musculoskeletal Tumor Society (MSTS) score

    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.

    Postoperative 1st week

  • Musculoskeletal Tumor Society (MSTS) score

    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.

    Postoperative 1st month

  • Toronto Extremity Salvage Score (TESS)

    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.

    Preoperative

  • Toronto Extremity Salvage Score (TESS)

    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.

    Postoperative 1st day

  • Toronto Extremity Salvage Score (TESS)

    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.

    Postoperative 1st week

  • Toronto Extremity Salvage Score (TESS)

    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.

    Postoperative 1st month

  • Visual analog scale (VAS)

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

    Preoperative

  • Visual analog scale (VAS)

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

    Postoperative 1st day

  • Visual analog scale (VAS)

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

    Postoperative 1st week

  • Visual analog scale (VAS)

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

    Postoperative 1st month

  • Upper Extremity Functional Scale (UEFS)

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

    Preoperative

  • Upper Extremity Functional Scale (UEFS)

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

    Postoperative 1st day

  • Upper Extremity Functional Scale (UEFS)

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

    Postoperative 1st week

  • Upper Extremity Functional Scale (UEFS)

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

    Postoperative 1st month

  • Disabilities of Arm, Shoulder and Hand (DASH)

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

    Preoperative

  • Disabilities of Arm, Shoulder and Hand (DASH)

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

    Postoperative 1st day

  • Disabilities of Arm, Shoulder and Hand (DASH)

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

    Postoperative 1st week

  • Disabilities of Arm, Shoulder and Hand (DASH)

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

    Postoperative 1st month

  • Lower Extremity Functional Scale (LEFS)

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

    Preoperative

  • Lower Extremity Functional Scale (LEFS)

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

    Postoperative 1st day

  • Lower Extremity Functional Scale (LEFS)

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

    Postoperative 1st week

  • Lower Extremity Functional Scale (LEFS)

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

    Postoperative 1st month

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

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

    Preoperative

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

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

    Postoperative 1st day

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

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

    Postoperative 1st week

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

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

    Postoperative 1st month

Secondary Outcomes (2)

  • Days at hospital after surgery

    up to 1 month

  • Survival

    up to 3 months

Study Arms (3)

endoprosthetic reconstruction

This is the group of patients with metastatic pathologic fractures treated with endoprosthesis. For example, proximal femur prosthesis for femoral neck fractures.

Procedure: endoprosthetic reconstruction

intramedullary nail

This is the group of patients with metastatic pathologic fractures treated with intramedullary nail, and additional bone cement if needed. For example, proximal femur nail for trochanteric fractures, or long femoral nail for femoral shaft fractures.

Procedure: Intramedullary nailing

open reduction internal fixation with plate and screws

This is the group of patients with metastatic pathologic fractures treated with open reduction internal fixation; with plates and screws. For example, reconstruction plates for pelvic fractures or 3.5 locking compression plates for humeral or femur shaft fractures.

Procedure: Open reduction internal fixation with plate and screws

Interventions

endoprosthetic reconstructionPROCEDURE

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

endoprosthetic reconstruction
Intramedullary nailingPROCEDURE

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.

intramedullary nail
Open reduction internal fixation with plate and screwsPROCEDURE

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.

open reduction internal fixation with plate and screws

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population includes patients with metastatic pathologic fractures treated via endoprosthesis, intramedullay nail or plate \& screws.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University Medical Faculty

Ankara, altindag, 06230, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Fractures, SpontaneousNeoplasm Metastasis

Interventions

Fracture Fixation, IntramedullaryBone Plates

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fracture Fixation, InternalFracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, OperativeInternal FixatorsProstheses and ImplantsEquipment and SuppliesOrthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentSurgical Fixation Devices

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 26, 2023

First Posted

April 24, 2023

Study Start

January 1, 2022

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

March 5, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Final MSTS, TESS, UEFS, LEFS, DASH, WOMAC, VAS will be shared when the study is completed.

Locations

TU(1)