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Completed

NCT Number: NCT03385694

Long Term Clinical and Functional Outcome in Rotationplasty Patients

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.

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Key information

Conditions

Disability Physical Psychological Adaptation

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Rotationplasty patients operated at IOR

Exclusion criteria

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

Treatment and study plan

Assessment

Diagnostic Test

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

Primary outcomes

  1. Hip X ray assessment

    Time frame: 4.12.2017 - 3.12.2018

    Pelvic frontal X-ray

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Acronym: GIROMEETING

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 28, 2017
Registry last updated
Dec 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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