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临床试验/NCT06737770
NCT06737770招募中不适用

Clinical and Functional Assessment of Patients With Transfemoral Amputation Treated With Osteointegrated Implant

Istituto Ortopedico Rizzoli1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年1月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
15
试验地点
1
主要终点
EQ-5D-5L

研究概览

简要总结

Limb amputation is a traumatic event that significantly reduces the ability to perform daily activities, impairs mobility, and lowers quality of life. In Italy, approximately 4 million people live with disabilities, with 1.2 million having motor disabilities. Among lower limb amputees (around 200,000), most are elderly, with amputations due to diabetic or vascular issues. Other groups include middle-aged adults (often victims of workplace accidents) and young individuals (victims of traffic accidents).

Post-amputation rehabilitation mainly involves the use of prostheses, which, however, can cause skin problems due to the socket (the part that anchors the prosthesis to the residual limb). Among patients using a socket, 34-63% develop chronic skin issues and pain. Complications include excessive sweating, sores, abscesses, and irritation. Additionally, daily volume changes in the residual limb and long-term weight fluctuations further complicate the use of conventional prostheses.

In the last two decades, research groups, assisted by experienced surgeons, have worked to develop implant solutions that bypass the socket and address these issues. One such solution is osteointegrated prostheses, which use the principle of osteointegration to anchor the prosthesis directly to the bone of the residual limb. A metal stem is surgically inserted into the medullary canal of the residual limb and fixed through bone growth, establishing a direct connection between the amputated limb and the external prosthesis.

Osteointegrated prostheses are widely accepted worldwide as a valid alternative to socket prostheses, especially for young and active individuals with transfemoral, transtibial, transhumeral, or transradial amputations not caused by vascular issues. The key benefit of osteointegration is the restoration of load alignment along the anatomical and mechanical axis, improving control of the residual limb during walking, as well as overall functional capacity and quality of life. Other advantages include greater stability, enhanced sitting comfort, a wider range of hip movement, faster attachment and detachment of the prosthesis, and improved body perception. Additionally, the direct contact between the metal stem and the bone generates sensory feedback (osteoperception), allowing the patient to better control the amputated limb by perceiving ground contact through vibrations transmitted to the bone. Osteointegration offers the only viable alternative for prosthetic use in patients with a short residual limb, where conventional socket prostheses would not be suitable.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects of both sexes, aged between 18 and 65 years;
  • Subjects with unilateral transfemoral amputation, following trauma, tumor, infection, or congenital defect;
  • Subjects already scheduled for osteointegrated prosthesis surgery for amputation;
  • BMI < 35 kg/m²;
  • Difficulty in using the traditional socket prosthesis (pain, reduced mobility, short residual limb, skin infections, ulcers, volume changes in the residual limb);
  • Subjects who have signed informed consent and reviewed the study information sheet.

排除标准

  • Peripheral vascular diseases;
  • Pregnancy;
  • Rheumatoid arthritis;
  • Neurological deficits;
  • Amputation of the contralateral limb;
  • Active infections;
  • Immunodeficiency;
  • Comorbidities/concurrent disabilities, general or localized (Multiple Sclerosis, Parkinson's disease, muscle tone disorders, malignant neoplasms, etc.), that may interfere with the study;
  • Presence of uncontrolled psychiatric comorbidities;
  • Declared or evident cognitive deficits that would impair understanding of the tasks required (MMSE ≤ 24);
  • Insufficient degree of cooperation;
  • Length of the bone stump (measured from the lesser trochanter to the apex of the stump) less than 15 cm;
  • Previous radiotherapy on the amputated limb;
  • Ongoing chemotherapy treatments.
  • Relative exclusion criteria:
  • Uncontrolled diabetes;
  • Previous infections;
  • Presence of additional joint prostheses on the same limb;
  • Osteoporosis with a T-score of -2.5 or lower.

研究组 & 干预措施

patients undergoing osseointegration surgery for transfemoral amputation

Experimental

干预措施: osseointegrated surgery for transfemoral amputation (Procedure)

结局指标

主要结局

EQ-5D-5L

时间窗: 12 months after surgery

It is a generic tool for measuring perceived quality of life in relation to health status, divided into 5 domains, each assigned a score ranging from 1 (best possible outcome) to 5 (worst possible outcome): mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. Additionally, there is a domain related to general health, scored from 0 (worst possible health status) to 100 (best possible health status)

次要结局

  • Q-TFA(12 months after surgery)
  • VAS(12 months after surgery)
  • ABIS(12 months after surgery)
  • TAPES(12 months after surgery)
  • PWB-PTCQ(12 months after surgery)
  • WHODAS 2.0(12 months after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefano Zaffagnini

Full Professor Medicine and Surgery, University of Bologna

Istituto Ortopedico Rizzoli

研究点 (1)

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