Disability PhysicalGIROMEETINGNCT03385694
Long Term Clinical and Functional Outcome in Rotationplasty Patients
An observational study of Disability Physical and Psychological Adaptation, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
Rotationplasty is a very special surgical technique. In its most frequent variant it allows, in the bone sarcomas of the distal femur, to remove all the thigh tissues including the knee joint keeping intact the innervation of the leg and the foot that are transplanted proximally after a 180 ° rotation and joined to… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Disability Physical, Psychological Adaptation
- What is being tested?
- Assessment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 23 Nov 2017to 3 Dec 2018
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Long survivor patient operated on knee rotationplasty for bone tumors
Who may be able to join
- Rotationplasty patients operated at IOR
Who cannot join
- Disagreement of patient to participate to the study (or of part of it)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long Term Clinical and Functional Outcome in Patients Operated on Van Ness-Borggreve Rotationplasty for Lower Limnb Bone Tumor
Rotationplasty is a very special surgical technique. In its most frequent variant it allows, in the bone sarcomas of the distal femur, to remove all the thigh tissues including the knee joint keeping intact the innervation of the leg and the foot that are transplanted proximally after a 180 ° rotation and joined to the proximal femoral stump.
It is currently the first choice in children under the age of 6 with a bone sarcoma localized to the distal femur but also finds indication in all age groups in cases of extremely voluminous and extended to the entire thigh with the oncological need to remove in block femur, knee and all the muscular involved. The objective of the study is to obtain information about the clinical and functional status of the limb operated in long-term surviving patients. In particular in this study the problem of the possible degenerative pathology of the hip on the operated side will be addressed. Moreover the psychic and psychological well-being of this population with particular reference to gender and motherhood will be tested.
Read the detailed description
30 long term survivors of rotationplasty patients at the IOR will be welcomed by the research team. They will be introduced to the aims of the research and the methodology and timing of the assessment.
The two-day agenda will be communicated to perform in a coordinated manner so that each patient performs all the exams:
- X ray pelvis
- Physiatric, orthopedic and prosthetic examination
- Proprioceptive test with Delos system
- Psychological questionnaires
- Conditions
- Disability Physical, Psychological Adaptation
- Being tested
- Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentDiagnostic test
Pelvic coronal X-ray, proprioceptive test with Delos system, questionnaires administration, orthopaedic, physiatric and prosthetic assessment
| Study group | Role | What they receive |
|---|---|---|
| Assessment | All the patients operated on Van Nes Rotationplasty for bone tumors at IOR and long term surviving Receives: Diagnostic Test: Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip X ray assessment
Pelvic frontal X-ray
Measured: 4.12.2017 - 3.12.2018
Secondary outcomes (8)
Physiatric Assessment
Muscular strenght (MMT)
Measured: 4.12.2017 - 3.12.2018
Orthopaedic assessment
Joints ROM (degrees)
Measured: 4.12.2017 - 3.12.2018
Prostheses Assessment
Leg lenght difference (cm)
Measured: 4.12.2017 - 3.12.2018
Symptoms
Symptom Checklist-90
Measured: 4.12.2017 - 3.12.2018
Well being
Psychological Well-being Scales The Italian validated version, Review of Psychiatry, 2003, 38, 3, pp.117-130) will be used. The reduced version from the 18-item test (3 items for each of the 6 dimensions of psychological well-being) will be used. Each item is assigned a score variable from 1 (= it is not my case / I do not agree) to 6 (= it is just so / perfectly agree). Some items are expressed in negative form and therefore in scoring the score assigned by the subject must be reversed. Adding the scores of the triplets you get a score for each of the 6 dimensions / subscales: autonomy, environmental control, positive relationships with others, self-acceptance, purpose in life and personal growth. Instead, the sum of the value of all 18 items gives an overall value of psychological well-being. At higher scores there is a higher level of well-being (both general and specific for each of the 6 measured dimensions).
Measured: 4.12.2017 - 3.12.2018
Psychological status
Rosenberg Self-Esteem Scale The version translated and validated in Italian by Professor Miretta Prezza of the University of Florence (Bulletin of Applied Psychology, 1997, 223, 35-44) will be used. It measures the attitude towards oneself through 10 items, to which the subject must respond by assigning a score from 1 (strongly disagree) to 4 (strongly agree) The scores of the negative items are reversed. The total score, obtained by adding the scores of the individual items, at higher values corresponds to an attitude more positive towards oneself.
Measured: 4.12.2017 - 3.12.2018
Body Image
Amputees Body Image Scale by James W. Breakey published in the Journal of Prosthetics and Orthotics (Volume 9, Number 2 / Spring 1997).
It has never been translated and validated in Italian, it has been translated and adapted (to amputation + gyroplasty) for this study.
It evaluates the disturbance in the perception of the body image on a frequency scale (from ever to ever) to 5 points ((1 = never; 5 = always) .It consists of 20 items (3 of which are expressed in 'positive' and therefore to be counted by inverting the score.) The scale gives an overall value (obtained by adding the score of all the items), which goes from 20 to 100: at higher scores there is a greater problematic in the perception of one's body image.
Measured: 4.12.2017 - 3.12.2018
Balance assessment
Delos proprioceptive system
Measured: 4.12.2017 - 3.12.2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study start23 Nov 2017
- Primary completion19 Feb 2018
- Study completion3 Dec 2018
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 Disability PhysicalStudies 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
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariagrazia Benedetti, Istituto Ortopedico Rizzoli
- Investigators
- Maria Grazia Benedetti, Principal investigator, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385694
- Sponsor's protocol ID
- 0010899
- Acronym
- GIROMEETING
- Status last verified
- Dec 2018
- First submitted
- 4 Dec 2017
- Last updated
- 31 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benedetti MG, Okita Y, Recubini E, Mariani E, Leardini A, Manfrini M. How Much Clinical and Functional Impairment do Children Treated With Knee Rotationplasty Experience in Adulthood? Clin Orthop Relat Res. 2016 Apr;474(4):995-1004. doi: 10.1007/s11999-016-4691-9. Epub 2016 Jan 11.
PubMed 26754115
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Clinical and Functional Outcome in Patients Operated on Van Ness-Borggreve Rotationplasty for Lower Limnb Bone Tumor
- ClinicalTrials.gov ID
- NCT03385694
- Acronym / sponsor ID
- GIROMEETING / 0010899
- Conditions
- Disability Physical, Psychological Adaptation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 23 Nov 2017 (actual)
- Primary completion
- 19 Feb 2018 (actual)
- Study completion
- 3 Dec 2018 (actual)
- First posted
- 28 Dec 2017 (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.
Rotationplasty is a very special surgical technique. In its most frequent variant it allows, in the bone sarcomas of the distal femur, to remove all the thigh tissues including the knee joint keeping intact the innervation of the leg and the foot that are transplanted proximally after a 180 ° rotation and joined to the proximal femoral stump.
It is currently the first choice in children under the age of 6 with a bone sarcoma localized to the distal femur but also finds indication in all age groups in cases of extremely voluminous and extended to the entire thigh with the oncological need to remove in block femur, knee and all the muscular involved. The objective of the study is to obtain information about the clinical and functional status of the limb operated in long-term surviving patients. In particular in this study the problem of the possible degenerative pathology of the hip on the operated side will be addressed. Moreover the psychic and psychological well-being of this population with particular reference to gender and motherhood will be tested.
Detailed description
30 long term survivors of rotationplasty patients at the IOR will be welcomed by the research team. They will be introduced to the aims of the research and the methodology and timing of the assessment.
The two-day agenda will be communicated to perform in a coordinated manner so that each patient performs all the exams:
- X ray pelvis
- Physiatric, orthopedic and prosthetic examination
- Proprioceptive test with Delos system
- Psychological questionnaires
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assessment | – | Diagnostic Test: AssessmentAll the patients operated on Van Nes Rotationplasty for bone tumors at IOR and long term surviving |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Long survivor patient operated on knee rotationplasty for bone tumors
Key inclusion criteria (1 listed)
- Rotationplasty patients operated at IOR
Key exclusion criteria (1 listed)
- Disagreement of patient to participate to the study (or of part of it)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AssessmentPelvic coronal X-ray, proprioceptive test with Delos system, questionnaires administration, orthopaedic, physiatric and prosthetic assessment | Diagnostic test | Assessment |
Primary outcome
Hip X ray assessment
Time frame: 4.12.2017 - 3.12.2018
Pelvic frontal X-ray
8 secondary outcomes
Physiatric Assessment
Time frame: 4.12.2017 - 3.12.2018
Orthopaedic assessment
Time frame: 4.12.2017 - 3.12.2018
Prostheses Assessment
Time frame: 4.12.2017 - 3.12.2018
Symptoms
Time frame: 4.12.2017 - 3.12.2018
Well being
Time frame: 4.12.2017 - 3.12.2018
Psychological status
Time frame: 4.12.2017 - 3.12.2018
Body Image
Time frame: 4.12.2017 - 3.12.2018
Balance assessment
Time frame: 4.12.2017 - 3.12.2018
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 31 Dec 2018.
- Results publication: PubMed 26754115Benedetti MG, Okita Y, Recubini E, Mariani E, Leardini A, Manfrini M. How Much Clinical and Functional Impairment do Children Treated With Knee Rotationplasty Experience in Adulthood? Clin Orthop Relat Res. 2016 Apr;474(4):995-1004. doi: 10.1007/s11999-016-4691-9. Epub 2016 Jan 11.
- Individual participant dataSharing planned: No
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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.
Maria Grazia Benedetti principal investigator
Istituto Ortopedico Rizzoli
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 Disability Physical and Psychological Adaptation, 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 1 inclusion and 1 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 31 Dec 2018. 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?
Hip X ray assessment (time frame: 4.12.2017 - 3.12.2018). 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 NCT03385694, 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 31 Dec 2018.