Clinical trial · Observational
Functional Outcomes and Quality of Life in Musculoskeletal Tumor Patients With Distal Femoral Megaprostheses
Evaluating Functional Outcomes and Quality of Life in Musculoskeletal Tumor Patients With Distal Femoral Megaprostheses: A Case-Control Study
NCT06282198CI-TRIAL-00082242FOQ-DFPcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to evaluate the functional outcomes of patients with distal femur tumor prostheses in comparison to a matched control group.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Distal Femoral Musculoskeletal Tumors | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Cases
- description
- Patients with Distal Femoral megaprosthesis
- label
- Control
- description
- Healthy subjects
Primary outcomes (3)
- measure
- SF-36 questionnaire
- timeFrame
- 3 months
- description
- This instrument assesses health-related quality of life and comprises 36 items, organized into eight subscales: physical functioning (10 items), physical role functioning (4 items), bodily pain (2 items), general health perceptions (5 items), vitality (4 items), social functioning (2 items), emotional role functioning (3 items), and mental health (5 items). Each subscale is scored on a scale from 0 to 100, with higher scores indicating better health status in that domain. In addition to individual subscale scores, two aggregate summary scores are calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). These summary scores are norm-based, with a mean of 50 and a standard deviation of 10, allowing comparison to population averages. Scores above 50 represent better-than-average health, while scores below 50 indicate lower-than-average health-related quality of life.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria (cases group): * Megaprosthesis of unilateral distal femur * Tumor cause * Ambulation capacity Exclusion Criteria (cases group): * Neurological alterations prior to the inervention than affect the lower limbs or general movement * Patient incapable of ambulation due to progression of his/her pathology * Patient with palliative treatment for advanced tumor diseas * More than one ipsilateral or contralateral prosthesis * Infection, traumatic or sequel to revision surgery cause
References
Publications (0)
Data not yet available
No reference posted for this study.