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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03385694
Recruitment Status : Completed
First Posted : December 28, 2017
Last Update Posted : December 31, 2018
Sponsor:
Information provided by (Responsible Party):
Mariagrazia Benedetti, Istituto Ortopedico Rizzoli

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.


Condition or disease Intervention/treatment
Disability Physical Psychological Adaptation 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

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long Term Clinical and Functional Outcome in Patients Operated on Van Ness-Borggreve Rotationplasty for Lower Limnb Bone Tumor
Actual Study Start Date : November 23, 2017
Actual Primary Completion Date : February 19, 2018
Actual Study Completion Date : December 3, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

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




Primary Outcome Measures :
  1. Hip X ray assessment [ Time Frame: 4.12.2017 - 3.12.2018 ]
    Pelvic frontal X-ray


Secondary Outcome Measures :
  1. Physiatric Assessment [ Time Frame: 4.12.2017 - 3.12.2018 ]
    Muscular strenght (MMT)

  2. Orthopaedic assessment [ Time Frame: 4.12.2017 - 3.12.2018 ]
    Joints ROM (degrees)

  3. Prostheses Assessment [ Time Frame: 4.12.2017 - 3.12.2018 ]
    Leg lenght difference (cm)

  4. Symptoms [ Time Frame: 4.12.2017 - 3.12.2018 ]
    Symptom Checklist-90

  5. Well being [ Time Frame: 4.12.2017 - 3.12.2018 ]
    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).

  6. Psychological status [ Time Frame: 4.12.2017 - 3.12.2018 ]
    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.

  7. Body Image [ Time Frame: 4.12.2017 - 3.12.2018 ]

    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.


  8. Balance assessment [ Time Frame: 4.12.2017 - 3.12.2018 ]
    Delos proprioceptive system



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Long survivor patient operated on knee rotationplasty for bone tumors
Criteria

Inclusion Criteria:

- Rotationplasty patients operated at IOR

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03385694


Locations
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Italy
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Investigators
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Principal Investigator: Maria Grazia Benedetti Istituto Ortopedico Rizzoli
Publications of Results:
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Responsible Party: Mariagrazia Benedetti, MD Director Physical Medicine and Rehabilitation Unit, Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT03385694    
Other Study ID Numbers: 0010899
First Posted: December 28, 2017    Key Record Dates
Last Update Posted: December 31, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No