Limb length discrepancy and impact on patient reported outcome measures in individuals with rotationplasty (ROTMAT).
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Limb length discrepancy as measured by a difference in knee heights on standard of care X- ray (radiographs).
研究概览
简要总结
Rotationplasty is a reconstructive procedure after bone tumor removal in kids with a growing skeleton, usually below the age of 10 – 12. Removal of tumor involves removal of the part of bone that has the growth plate, which lead to that limb being ’short’ as the normal limb keeps growing. Conventional reconstruction with a prostheses that is used for adults leads to significant limb length discrepancy as the normal limb continues to grow and the leg with endoprosthesis does not.
An expandable prosthesis, is prohibitively expensive, costs around 30 lakhs just for the prosthesis, not counting the need for future revisions.
Rotationplasty is a single procedure, where the operated knee is kept longer than the ‘unaffected’ knee, such that they are expected to be near equal at adulthood. These predictions of limb length discrepancy are made from algorithms that predict the growth of both the operated limb and ‘unaffected’ limb. Despite best efforts, these predictions may err on either side, leaving the operated knee a little short or a little longer than the ‘normal’ knee. The effect this ‘knee’ length discrepancy has on functional outcome is not well known.
This prospective study will measure ‘knee’ length difference in patients who have reached adulthood, where further increase in height is not expected, its effect on their function as measured by their treating doctor (physician reported functional outcome measures) and as noted by patients themselves (patient reported functional outcome measures), and gait analyses to compare outcomes with similar age patients who have had an amputation.
Patients of Rotationplasty who have reached at least 1 year of follow up shall be seen at their usual follow up appointment. Knee difference will be measured on an X-ray. All patients shall be requested to fill test scores.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Rotationplasty patients with at least 1 year of follow up.
- •Patients of any age and any sex shall be recruited for functional outcome and gait analyses.
- •Patients who have reached skeletal maturity (physeal fusion seen on plain X-Ray) for primary outcome measure of knee length discrepancy.
排除标准
- •Rotationplasty patients with less than 1 year follow up.
- •Those who present with local and/or systemic relapse.
结局指标
主要结局
Limb length discrepancy as measured by a difference in knee heights on standard of care X- ray (radiographs).
时间窗: Single point assessment after enrollment.
Knee height will be measured from ASIS (anterior superior iliac spine) to the center of the talus on a scannogram taken in an upright weight bearing stance with the prosthesis in use and pelvis squared. The normal limb knee length shall be measured from ASIS to the center of the knee joint.
时间窗: Single point assessment after enrollment.
次要结局
- 1. Patient or Parent reported outcome measure measured as a continuous variable using pTESS (English) / TESS(English/Marathi/Hindi).(2. Gait analyses 3D gait analysis to assess movement characteristics such as joint angular kinematics, kinetics, & spatiotemporal gait parameters using a 12-camera Qualisys® 3D Motion Capture System (Qualisys AB, Götebor, Sweden).)
研究者
Dr Prakash Nayak
Tata Memorial Hospital, Mumbai
