Clinical trial on the efficacy and safety of corrective osteotomy for the upper extremity using custom-made surgical guide and bone plate (exploratory research)

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000014833
• Date of registration: 15/08/2014
• Prospective Registration: Yes
• Primary sponsor: Osaka University
• Public title: Clinical trial on the efficacy and safety of corrective osteotomy for the upper extremity using custom-made surgical guide and bone plate (exploratory research)
• Scientific title: Clinical trial on the efficacy and safety of corrective osteotomy for the upper extremity using custom-made surgical guide and bone plate (exploratory research) - Clinical trial of deformity correction of the upper extremity using custom- made surgical guide and bone plate
• Date of first enrolment: 2015/01/01
• Target sample size: 16
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014053
• Study type: Interventional
• Study design: Single arm Non-randomized
• Phase: Phase II

Countries of recruitment

Japan

Contacts

• Name: Tsuyoshi Tsuyoshi Murase
• Affiliation: Osaka University Graduate School of Medicine Department of Orthopaedic Surgery

• Name: Tatsuhiro Tatsuhiro Hanai
• Affiliation: Osaka University Graduate School of Medicine Department of Orthopaedic Surgery

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1. Sever shortening of the bone that cannot be corrected at one time. 2. Coincidence of two or more deformities in one bone. 3. Coincidence of the forearm and upper arm deformities at the same side. 4. Patient aged 15<= and <20 years who need internal fixation across the growth plate. 5. Patient with deformity of the same bone at the opposite side. 6. Inappropriate candidate for general anesthesia. 7. Patient with active malignant tumor. 8. Patient who is pregnant or possibly pregnant. Patient who hope to be pregnant during her trial. 9. Patient who is administrated anticoagulant that cannot be interrupted for the operation 10. Patient with generalized infection. 11. Patient with hemorrhagic diathesis that inhibits surgery. 12. Patient with allergic reaction to the custom-made guide or its component. 13. Patient with allergic reaction to the custom-made bone plate or its component. 14. Patient who underwent surgery using custom-made surgical guide and bone plate before. 15. Patient who has metal implant in the upper extremity of the same side for the operation. 16. Patient who entered another clinical trial or trials within one month before the start of this trial.

Age minimum: 10years-old
Age maximum: 75years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Deformity of the upper extremity (malunited fracture, early closure of the growth plate, congenital anomaly)

Intervention(s)

Surgery for deformity correction of the upper extremity using custom-made surgical guide and bone plate based on preoperative computer simulation with CT data

Primary Outcome(s)

The maximum postoperative residual angle of deformity calculated from the radiographic measurements

Secondary Outcome(s)

1. Deformity angles on plain radiographs 2. Radio-Ulnar discrepancy (only for the cases with a deformity/ deformities of the radius and/or ulna) 3. Radiographic bony union 4. Clinical evaluation #1. Range of motion of the adjacent joint #2. Instability of the adjacent joint #3. Pain evaluated by Visual Analogue Scale(VAS) #4. Grip strength #5.Patient based outcome measures (DASH score, Quick DASH score) #6. Patient satisfaction 5. Accuracy of the deformity correction evaluated using CT computer bone model 6. Easiness of the use of the guides and bone plate in surgery 7.Clinical evaluation (WBC count, CRP) 8. Adverse events

Source(s) of Monetary Support

Japan Agency for Medical Research and Development

None

Secondary Sponsor(s)

Nagoya University Graduate School of Medicine

Ethics review

Status: YES
Approval date:
Contact:

[e-mail]

IRB Osaka University

06-6879-6551

[e-mail]

Results

• Results available: Yes
• Date Completed: 19/05/2017