Prospective, Observational Study to Assess the Pain, Satisfaction, and Quality of Life of Patients Implanted With the FITBONE® Lengthening Nail
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 6
- 主要终点
- Describe Patients' Pain by Visual Analog Scale (VAS)
研究概览
简要总结
This study is a prospective observational non-interventional multi-centre cohort study of patients, 12 years or older, initiating a lower limb lengthening procedure with FITBONE and who have a length discrepancy of 30mm or more between the limbs.
The following parameters will be assessed for up to 24 months.
- Pain using the Visual Analog Scale (VAS), Patient Global Assessment (PGA) and Clinical Observer Global Assessment (COGA)
- Patient satisfaction using the Patient Global Impression of change (PGI-C) scale
- QoL using the 36-Item Short Form Survey/Paediatric Quality of Life Inventory (SF-36/PedsQL)
详细描述
The study period is 24 months post-surgery. Each patient's demographic data, medical history, any relevant concomitant medication, physical examination, range of motion data will be recorded using a standardized case record form after informed consent is provided and the healthcare provider completes a physical examination regarding the patient's conditions and record determination as to whether FITBONE is recommended. The decision to treat, observe, and to include in this observation study is at the discretion of the healthcare provider. This is an observational study and therefore, the participating healthcare provider will manage patients according to the usual clinical practice.
Surgery will be performed according to the standard surgical procedure described previously. Study of Investigational Product(s). Five to ten days after the lengthening nail placement, the lengthening mechanism is operated by transmitting energy necessary for the lengthening from the outside. This period is referred to as the distraction period. The rhythm of lengthening and strict protocol for an individual patient, indicating the daily lengths of lengthening to be applied, are decided by the healthcare provider taking into account all influencing factors. Therefore, the end of the distraction period, bone healing, implant removal, and 6 months post-implant removal may differ by individual. In the event the distraction period is extended by the healthcare provider, the new distraction period will determine the end of the distraction time point. All patients will be followed until the end of the scheduled study period regardless of any change in their treatment or other conditions.
Six visits are planned:
- Surgery (baseline)
- End of the distraction phase
- End of bone healing
- Implant removal
- 6-month post-removal
- 24-month post-surgery The satisfaction will be assessed at implant removal, 6 months post implant removal, and 24 months post-surgery.
The QoL will be assessed at baseline, at 6 months post implant removal, and 24 months post-surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥12 years old, with congenital or acquired lower limb discrepancy greater than 30mm, undergoing femoral or tibia bone lengthening with FITBONE
- •Patients with a regular indication for a surgical intervention with FITBONE according to manufacturer IFU
- •The patient (or his/her legally acceptable representative) is capable of understanding the content of the Informed Consent Form (ICF)
- •The informed consent form is correctly obtained
排除标准
- •Patients with a medical condition that is contraindicated according to the FITBONE instruction for use.
- •Patients with any conditions that, in the Investigator's opinion, may interfere with the study execution, including those likely to be lost to follow-up.
- •Patients who have any conditions or medical condition that, in the investigator's opinion, may interfere with the study's execution or in which the patient should not participate for safety reasons.
- •Patients requiring the application of or have already in-situ concomitant devices that cannot be safely removed (except for permitted concomitant devices).
- •Patients participating in other clinical or have taken part in any clinical study in the last 3 months.
结局指标
主要结局
Describe Patients' Pain by Visual Analog Scale (VAS)
时间窗: at 6 months after implant removal date and at 24 months follow-up
Pain will be measured by the Pain by Visual Analog Scale (VAS), performed by the patient, through the Patient Global Evaluation Assessment and by the physician (Clinical Observer Global Assessment). The VAS for pain ranges from 0 to 10, with 0 representing no pain and 10 representing the worst imaginable pain.
Describe Patients' patient Quality of Life (QoL) using Short Form 36 Health Survey (SF-36) for adult patients and PedsQL (Pediatric Quality of Life Inventory) Generic Core Scale for children patients.
时间窗: at 6 months after implant removal date and at 24 months follow-up
The Quality of Life (QoL) will be measured by the Short Form 36 Health Survey (SF-36) or PedsQL (Pediatric Quality of Life Inventory) Generic Core Scale, depending on the patient's age at enrolment: SF-36 for adults and PedsQl for children. Short Form 36 Health Survey has two components: Physical Component Summary (PCS) Minimum 0, Maximum 100; Mental Component Summary (MCS) Minimum 0, Maximum 100. Higher scores on both the Physical and Mental Component Summary scales indicate a better outcome, reflecting better health-related quality of life. The PedsQL Generic Core Scales are scored on a scale of 0 to 100, with higher scores indicating better health-related quality of life and 0 represents the worst health-related quality of life.
Describe Patients' satisfaction
时间窗: at 6 months after implant removal date and at 24 months follow-up
A dedicated patients satisfaction questionnaire has been developed with key opinion leaders (KOLs) and expert groups on the limb leg discrepancy treatment. The satisfaction questionnaire is made of 5 questions, for each question the patient have to reply using the Patient Global Impression of change ranging from 1 to 7, with 1 representing Very much improved; to 7 being Very much worse.
次要结局
- Describe pain at each visit using VAS(from surgery to 24 months follow-up)
- Effectiveness of Fitbone by limb lengthening(at the end of bone healing, approximately 6 months)
- Monitor the clinical safety of Fitbone by collecting and characterizing the complications, expressed as adverse events and device deficiencies, associated with FITBONE(from surgery to 24 months follow-up)
- Assess satisfaction evolution at implant removal , 6 months after Fitbone removal and at 24 months after surgery(from surgery to 24 months follow-up)
- Describe evolution of QoL at 6 months after Fitbone removal and at 24 months after surgery, compared to baseline(from surgery to 24 months follow-up)
- Describe patients Range Of Motion (ROM in degrees) evolution at end of bone healing and at 24 months after surgery compared to baseline(from surgery to 24 months follow-up)