Long Term Clinical and Functional Outcome in Rotationplasty Patients (GIROMEETING)

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.

Study Overview

• Status: Completed
• Conditions: Disability Physical; Psychological Adaptation
• Intervention / Treatment: Diagnostic test: Assessment

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Istituto Ortopedico Rizzoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Long survivor patient operated on knee rotationplasty for bone tumors

Description

Inclusion Criteria:

- Rotationplasty patients operated at IOR

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Assessment; All the patients operated on Van Nes Rotationplasty for bone tumors at IOR and long term surviving	Diagnostic test: Assessment; Pelvic coronal X-ray, proprioceptive test with Delos system, questionnaires administration, orthopaedic, physiatric and prosthetic assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hip X ray assessment	Pelvic frontal X-ray	4.12.2017 - 3.12.2018

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiatric Assessment	Muscular strenght (MMT)	4.12.2017 - 3.12.2018
Orthopaedic assessment	Joints ROM (degrees)	4.12.2017 - 3.12.2018
Prostheses Assessment	Leg lenght difference (cm)	4.12.2017 - 3.12.2018
Symptoms	Symptom Checklist-90	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).	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.	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.	4.12.2017 - 3.12.2018
Balance assessment	Delos proprioceptive system	4.12.2017 - 3.12.2018

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli
• Investigators: Principal Investigator: Maria Grazia Benedetti, Istituto Ortopedico Rizzoli

Publications and helpful links

General 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. Erratum In: Clin Orthop Relat Res. 2016 Apr;474(4):1078-9.

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2017
• Primary Completion (Actual): February 19, 2018
• Study Completion (Actual): December 3, 2018

Study Registration Dates

• First Submitted: December 4, 2017
• First Submitted That Met QC Criteria: December 20, 2017
• First Posted (Actual): December 28, 2017

Study Record Updates

• Last Update Posted (Actual): December 31, 2018
• Last Update Submitted That Met QC Criteria: December 27, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 0010899

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No