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Long Term Clinical and Functional Outcome in Rotationplasty Patients

NCT ID: NCT03385694

Last Updated: 2018-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-23

Study Completion Date

2018-12-03

Brief Summary

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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

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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

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Disability Physical Psychological Adaptation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Assessment

All the patients operated on Van Nes Rotationplasty for bone tumors at IOR and long term surviving

Assessment

Intervention Type DIAGNOSTIC_TEST

Pelvic coronal X-ray, proprioceptive test with Delos system, questionnaires administration, orthopaedic, physiatric and prosthetic assessment

Interventions

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Assessment

Pelvic coronal X-ray, proprioceptive test with Delos system, questionnaires administration, orthopaedic, physiatric and prosthetic assessment

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

\- Rotationplasty patients operated at IOR

Exclusion Criteria

\- Disagreement of patient to participate to the study (or of part of it)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

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Mariagrazia Benedetti

MD Director Physical Medicine and Rehabilitation Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Grazia Benedetti

Role: PRINCIPAL_INVESTIGATOR

Istituto Ortopedico Rizzoli

Locations

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Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type RESULT
PMID: 26754115 (View on PubMed)

Other Identifiers

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0010899

Identifier Type: -

Identifier Source: org_study_id