Quality of Life of Patients With Bone Tumor of the Lower Limbs Treated With Salvage Surgery

Study Purpose

The aim of the study is to describe, through a minimum follow-up of 18 months, the quality of life of patients undergoing salvage surgery of lower limb for musculoskeletal tumors and to identify possible prognostic factor correlated. Quality of life will be evaluated with Bt-DUX (Bt=bone tumor)

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	12 Years - 90 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Patients 12 years of age or older with musculoskeletal cancer undergoing lower extremity salvage surgery.

Exclusion Criteria:

- patients undergoing amputation.

- patients with difficulties in understanding the Italian language

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05772312
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Istituto Ortopedico Rizzoli
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	riccardo ruisi
Principal Investigator Affiliation	Istituto Ortopedico Rizzoli
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Enrolling by invitation
Countries	Italy
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Sarcoma, Ewing, Osteosarcoma, Bone Tumor

Additional Details

Musculoskeletal cancers are extremely rare, accounting for approximately 0.2% of all cancers, 14% are bone sarcomas, which occur more frequently in children and adolescents. The most frequent location is at the metaphyseal level of the femur (42%) and tibia (19%). Surgery and chemotherapy treatments have significantly increased survival rates for patients with bone tumor. Early rehabilitation of these patients after surgery is to promote recovery as early as possible with maximum autonomy. In literature, data about the association between the early functional recovery and quality of life are few. Long-term studies about the quality of life of these patients are so necessary. The quality of life is measured with several scale that included a set of non-specific domains for bone tumor patients. For this reason, a specific assessment scale was introduced and validated in 2013 to measure the quality of life of patients with bone cancer of the lower limbs, the Bt-DUX scale. In 2019 the Bt-DUX scale was validated in Italian. Considering the rarity of the disease, and verified that the number of patients treated in 2019 and 2020, is 30 and 32, respectively, the investigators estimate to enroll from January 2019 to June 2023 a number of patients equal to 100, considering a rejection rate of 10%. Patient characteristics and scale values will be summarized using descriptive statistics (absolute frequencies and percentages for categorical variables, mean and standard deviation or median and interquartile range for continuous variables). The variables collected will be: age, sex, diagnosis, type of surgery, site of tumour, complication (infection, relapses, metastasis), TESS (Toronto Extremity Salvage Score) (at 3 and 6 months), knee or hip flexion (at 3 and 6 months), quadriceps or hip abductor strength (at 3 and 6 months) and time up and go (at 3 and 6 months). The relationship of patient characteristics with functional outcomes and quality of life will be investigated using multiple regression models, while the correlation between measures of functional recovery will be analyzed using Pearson's or Spearman's correlation coefficient, depending on the distribution of the variables considered. The aim of the study is to describe the quality of life of patients undergoing salvage surgery of the lower limb for musculoskeletal tumors with a long follow-up and to investigate the association with early functional recovery.

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International Sites

Istituto Ortopedico Rizzoli, Bologna, Italy

Status

Address

Istituto Ortopedico Rizzoli

Bologna, , 40136

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