Bone NeoplasmFISIO-ONCONCT06376539
Functional Recovery of Patients Undergoing Resection and Reconstruction of the Lower Limbs for Bone Tumor.
An observational study of Bone Neoplasm and Rehabilitation, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The aim of the present study is to describe the course of functional recovery of patients with musculoskeletal tumours and undergone resection and reconstruction operations of lower limbs in the first six months post-surgery, differentiating them on the basis of the anatomical level involved. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Bone Neoplasm, Rehabilitation
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 10 Apr 2024to 31 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All participants with bone tumor diagnosis treated at the hospital
Who may be able to join
- All participants undergone lower limb resection and reconstruction with localisation of the disease to the pelvis, femur femur, tibia and foot bones.
- All participants undergone soft tissue resection surgery on the of the lower limb
- All types of oncological diagnoses will be taken considered: osteosarcoma, Ewing and others.
Who cannot join
- Participants who undergo at our Institute only the surgical treatment while continuing adjuvant treatment at other centres
- Participants for whom no rehabilitation treatment has been activated during adjuvant treatment at our Institute
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Recovery in the First Six Postoperative Months of Cancer Patients Undergoing Lower Limb Resection and Reconstruction. An Observational Study
The aim of the present study is to describe the course of functional recovery of patients with musculoskeletal tumours and undergone resection and reconstruction operations of lower limbs in the first six months post-surgery, differentiating them on the basis of the anatomical level involved.
Read the detailed description
Retrospective observational study will be conducted. The evaluation of the patients clinical recovery progress will take place at three different times: during the hospital stay postoperative, at 3 and 6 months after surgery. Different outcome measures will be considered in order to provide a complete picture of the patients functional recovery and their change.
- Conditions
- Bone Neoplasm, Rehabilitation
- Keywords
- bone tumor, physiotherapy, functional recovery
- Medical subject headings
- Bone Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Toronto Extremity Salvage Score (TESS)
Person's level of independence. It is measured through 30 questions relating to 30 activities of daily living to be answered by the patient. The total score is reported from 0 to 100. A higher score indicates a greater degree of autonomy. A higher score indicates a greater degree of autonomy.
Measured: at 3 months after surgery
Toronto Extremity Salvage Score (TESS)
Person's level of independence. It is measured through 30 questions relating to 30 activities of daily living to be answered by the patient. The total score is reported from 0 to 100. A higher score indicates a greater degree of autonomy. A higher score indicates a greater degree of autonomy.
Measured: at 6 months after surgery
Secondary outcomes (8)
Range of motion (ROM)
The range of motion of the main joints of the lower limbs (hip, knee or foot), measured with a goniometer
Measured: at 3 months after surgery
Rang of motion - 2 (ROM)
The range of motion of the main joints of the lower limbs (hip, knee or foot), measured with a goniometer
Measured: at 6 months after surgery
Number of participants able to walk
Number of participant that are able to walk and aids used for walking
Measured: up to 1 week
Time Up and Go -2 (TUG)
Time it takes a person to get up from a chair, walk three metres, turn around, return to the chair and sit down again is measured.
Measured: at 3 months after surgery
Time Up and Go (TUG)
Time it takes a person to get up from a chair, walk three metres, turn around, return to the chair and sit down again is measured.
Measured: at 6 months after surgery
Muscle Strength
Grades of Muscle Strength from 0 (no contraction) to 5 (best strength)
Measured: at 3 months after surgery
Muscle Strength-2
Grades of Muscle Strength from 0 (no contraction) to 5 (best strength)
Measured: at 6 months after surgery
Number of day from surgery to first walking
The number of day that participants needs to recover ambulation after surgery
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start10 Apr 2024
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone NeoplasmStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376539
- Sponsor's protocol ID
- CEAVEC: 111/2024/Oss/IOR
- Acronym
- FISIO-ONCO
- Status last verified
- Feb 2026
- First submitted
- 15 Apr 2024
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morri M, Venturini E, Abbruzzese A, Meneghini M, Raffa D, Berti L, Donati D. The functional recovery trajectory in patients undergoing lower limb salvage surgery for bone tumour: an observational study. Support Care Cancer. 2026 Jan 28;34(2):136. doi: 10.1007/s00520-026-10374-x.
PubMed 41593389
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Recovery in the First Six Postoperative Months of Cancer Patients Undergoing Lower Limb Resection and Reconstruction. An Observational Study
- ClinicalTrials.gov ID
- NCT06376539
- Acronym / sponsor ID
- FISIO-ONCO / CEAVEC: 111/2024/Oss/IOR
- Conditions
- Bone Neoplasm, Rehabilitation
- Keywords
- bone tumor, physiotherapy, functional recovery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study is to describe the course of functional recovery of patients with musculoskeletal tumours and undergone resection and reconstruction operations of lower limbs in the first six months post-surgery, differentiating them on the basis of the anatomical level involved.
Detailed description
Retrospective observational study will be conducted. The evaluation of the patients clinical recovery progress will take place at three different times: during the hospital stay postoperative, at 3 and 6 months after surgery. Different outcome measures will be considered in order to provide a complete picture of the patients functional recovery and their change.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All participants with bone tumor diagnosis treated at the hospital
Key inclusion criteria (3 listed)
- All participants undergone lower limb resection and reconstruction with localisation of the disease to the pelvis, femur femur, tibia and foot bones.
- All participants undergone soft tissue resection surgery on the of the lower limb
- All types of oncological diagnoses will be taken considered: osteosarcoma, Ewing and others.
Key exclusion criteria (2 listed)
- Participants who undergo at our Institute only the surgical treatment while continuing adjuvant treatment at other centres
- Participants for whom no rehabilitation treatment has been activated during adjuvant treatment at our Institute
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Toronto Extremity Salvage Score (TESS)
Time frame: at 3 months after surgery
Person's level of independence. It is measured through 30 questions relating to 30 activities of daily living to be answered by the patient. The total score is reported from 0 to 100. A higher score indicates a greater degree of autonomy. A higher score indicates a greater degree of autonomy.
Toronto Extremity Salvage Score (TESS)
Time frame: at 6 months after surgery
Person's level of independence. It is measured through 30 questions relating to 30 activities of daily living to be answered by the patient. The total score is reported from 0 to 100. A higher score indicates a greater degree of autonomy. A higher score indicates a greater degree of autonomy.
8 secondary outcomes
Range of motion (ROM)
Time frame: at 3 months after surgery
Rang of motion - 2 (ROM)
Time frame: at 6 months after surgery
Number of participants able to walk
Time frame: up to 1 week
Time Up and Go -2 (TUG)
Time frame: at 3 months after surgery
Time Up and Go (TUG)
Time frame: at 6 months after surgery
Muscle Strength
Time frame: at 3 months after surgery
Muscle Strength-2
Time frame: at 6 months after surgery
Number of day from surgery to first walking
Time frame: up to 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Derived from this study: PubMed 41593389Morri M, Venturini E, Abbruzzese A, Meneghini M, Raffa D, Berti L, Donati D. The functional recovery trajectory in patients undergoing lower limb salvage surgery for bone tumour: an observational study. Support Care Cancer. 2026 Jan 28;34(2):136. doi: 10.1007/s00520-026-10374-x.
- Individual participant dataSharing planned: No
Related trials for Bone Neoplasm
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingObservational study
Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
Leukemia, Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Neoplasm and Rehabilitation, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toronto Extremity Salvage Score (TESS) (time frame: at 3 months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06376539, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.