Physician-initiated clinical trial of a custom-made surgical guide for malunited intra-articular wrist fracture

JRCT ID: jRCT2052200081

Registered date:06/11/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Malunited intra-articular fracture of the wrist joint
• Date of first enrollment: 28/10/2020
• Target sample size: 12
• Study type: Interventional
• Intervention(s): Accurate osteotomy performed using a custom-made surgical guide for malunited intra-articular wrist fracture.

Outcome(s)

• Primary Outcome: Maximum step (Step-off) on CT image at 52 weeks after surgery

Secondary Outcome

1. Image evaluation: CT, plain X-ray
2. Clinical evaluation: range of motion (wrist, forearm), pain, grip strength, patient-based evaluation, patient satisfaction
3. Evaluation at the time of surgery
4. Safety evaluation

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

1) Patients with wrist disorder* due to articular incongruity** caused by malunited intra-articular fracture of the distal radius
(*: One or more of the following symptoms or findings; restricted range of joint motion, pain, pre- or early stage osteoarthritis on plain radiograph)
(**: 2.0 mm or more joint surface step-off on CT image)
2) Patients who have been suffering for more than 3 months after receiving intra-articular fracture of the wrist
3) Patients 18 years or older and 75 years or younger at the time of obtaining consent (both male and female)
4) Patients for whom written consent has been obtained

Exclude criteria

1) Patients who were diagnosed to be unsuitable for intra-articular corrective osteotomy due to deformity associated with severe crushing and complicated external joint fracture
2) Patients who have advanced to end-stage osteoarthritis in the target joint and are diagnosed not to be eligible for intra-articular corrective osteotomy
3) Patients who are not suitable for general anesthesia or regional transmission anesthesia
4) Patients with active malignancy
5) Patients with rheumatoid arthritis or related diseases
6) Patients who are pregnant or may be pregnant, and those who wish to become pregnant during this study participation period
7) Patients who are unable to restrict anticoagulant medication or anticoagulant therapy for the surgery
8) Patients who have a hemorrhagic diathesis and are difficult to apply for surgery.
9) Patients with systemic infection
10) Patients with hypersensitivity to custom surgical guides or their component materials
11) Patients who have difficulty in CT simulation due to reasons such as indwelling of metal implants in the surgical site
12) Patients who participated in other clinical trials or clinical studies within 1 month before signed the consent form for the clinical trial
13) Patients who are judged by the investigator or sub-investigator to be unable to correctly understand the significance of the clinical trial and to follow the compliance requirements due to mental illness, etc.
14) Other patients for whom the investigator or subinvestigator has judged participation in the study to be inappropriate

Related Information

• Primary Sponsor: Murase Tsuyoshi
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development