Clinical trial NCT03385694: Long Term Clinical and Functional Outcome in Rotationplasty Patients
Official title: Long Term Clinical and Functional Outcome in Patients Operated on Van Ness-Borggreve Rotationplasty for Lower Limnb Bone Tumor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disability Physical
Psychological Adaptation
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2017-12-28
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Long survivor patient operated on knee rotationplasty for bone tumors

Brief 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 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

Eligibility criteria: Inclusion Criteria:

- Rotationplasty patients operated at IOR

Exclusion Criteria:

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

Primary outcomes:
measure: Hip X ray assessment
timeFrame: 4.12.2017 - 3.12.2018
Secondary outcomes:
measure: Physiatric Assessment
timeFrame: 4.12.2017 - 3.12.2018
measure: Orthopaedic assessment
timeFrame: 4.12.2017 - 3.12.2018
measure: Prostheses Assessment
timeFrame: 4.12.2017 - 3.12.2018
measure: Symptoms
timeFrame: 4.12.2017 - 3.12.2018
measure: Well being
timeFrame: 4.12.2017 - 3.12.2018
measure: Psychological status
timeFrame: 4.12.2017 - 3.12.2018
measure: Body Image
timeFrame: 4.12.2017 - 3.12.2018
measure: Balance assessment
timeFrame: 4.12.2017 - 3.12.2018
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: Maria Grazia Benedetti
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.