Reconstructive surgery by custom made implant for patients with long bone metastatic bone tumor

JRCT ID: jRCTs042190058

Registered date:29/07/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Metastatic bone tumor of long bone
• Date of first enrollment: 21/11/2019
• Target sample size: 25
• Study type: Interventional
• Intervention(s): Investigators place the custom made implant for metastatic bone tumor of long bone and follow up for 1 year.

Outcome(s)

• Primary Outcome: Limb functional after surgery

Secondary Outcome

1) Local pain ( Numerical Rating Scale, NRS)
2) Radiogram [International Symposium on Limb Salvage, ISOLS radiogram evaluation]
3) Operation time
4) Blood loss
5) Failure of the custom made implant
6) Survival ratio of the custom made implant
7) Oncological prognosis

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Resistant pain for conservative treatment
2) Pathologic fracture / urgency fracture
3) Prognosis for 3 months or more
4) Prognosis prolonged by tumor resection

Exclude criteria

1) Cases in which general anesthesia can not be applied
2) Underage cases
3) Cases that are assumed to have a high risk to protocol treatment
4) Cases in which communication can not be made by oneself

Related Information

• Primary Sponsor: Yasuda Taketoshi
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development
• Secondary ID(s): Nil known