Long Term Clinical and Functional Outcome in Rotationplasty Patients

Disability Physical Clinical Trial

— GIROMEETING  

Official title:

Long Term Clinical and Functional Outcome in Patients Operated on Van Ness-Borggreve Rotationplasty for Lower Limnb Bone Tumor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03385694
• Other study ID #: 0010899
• Status: Completed
• Start date: November 23, 2017
• Est. completion date: December 3, 2018

Study information

• Verified date: December 2018
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 3, 2018
• Est. primary completion date: February 19, 2018
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Rotationplasty patients operated at IOR

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Disability Physical
• Psychological Adaptation

Intervention

Diagnostic Test:
• Assessment
Pelvic coronal X-ray, proprioceptive test with Delos system, questionnaires administration, orthopaedic, physiatric and prosthetic assessment

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & 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/s11999-01 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hip X ray assessment	Pelvic frontal X-ray	4.12.2017 - 3.12.2018
Secondary	Physiatric Assessment	Muscular strenght (MMT)	4.12.2017 - 3.12.2018
Secondary	Orthopaedic assessment	Joints ROM (degrees)	4.12.2017 - 3.12.2018
Secondary	Prostheses Assessment	Leg lenght difference (cm)	4.12.2017 - 3.12.2018
Secondary	Symptoms	Symptom Checklist-90	4.12.2017 - 3.12.2018
Secondary	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
Secondary	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
Secondary	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
Secondary	Balance assessment	Delos proprioceptive system	4.12.2017 - 3.12.2018