Long Term Clinical and Functional Outcome in Rotationplasty Patients

NCT03385694 | Completed

• 1 other identifier: 0010899
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Disability Physical; Psychological Adaptation

Outcome Measures

Primary Outcomes (1)

• Hip X ray assessment

  Pelvic frontal X-ray

  4.12.2017 - 3.12.2018

Secondary Outcomes (8)

• Physiatric Assessment

  4.12.2017 - 3.12.2018

• Orthopaedic assessment

  4.12.2017 - 3.12.2018

• Prostheses Assessment

  4.12.2017 - 3.12.2018

• Symptoms

  4.12.2017 - 3.12.2018

• Well being

  4.12.2017 - 3.12.2018

Study Arms (1)

Assessment

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

Diagnostic Test: Assessment

Interventions

Assessment DIAGNOSTIC_TEST

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

Assessment

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Long survivor patient operated on knee rotationplasty for bone tumors

You may qualify if:

• \- Rotationplasty patients operated at IOR

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (1)

• 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.

  PMID: 26754115 RESULT

MeSH Terms

Interventions

Physical Examination

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Maria Grazia Benedetti

  Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Director Physical Medicine and Rehabilitation Unit

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 28, 2017
• Study Start: November 23, 2017
• Primary Completion: February 19, 2018
• Study Completion: December 3, 2018
• Last Updated: December 31, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)