UMIN-CTR Clinical Trial

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)

Acronym

Clinical trial of deformity correction of the upper extremity using custom- made surgical guide and bone plate

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)

Scientific Title:Acronym

Clinical trial of deformity correction of the upper extremity using custom- made surgical guide and bone plate

Region

Japan

Condition

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

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of the custom-made surgical guide and bone plate developed to realize a precise corrective osteotomy for the upper extremity.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

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

Key secondary outcomes

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

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

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

10

years-old

<=

Age-upper limit

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. Deformity of the upper extremity resulted from malunited fractures, growth plate disturbance and congenital anomaly that has each or both of the following conditions;
i) Disturbance of the adjacent joint or joints (restricted range of motion, instability, pain and/or osteoarthritis of the joint)
ii) Emotional distress and/or limited social activities by the unsightly appearance
2. The age at the informed consent is 10<= and <=75 years old for both genders.
3. The informed consent obtained from the patient his or herself (from the guardian when the patient is10<= and <15 years old and from the guardian and the patient his or herself when he or she is 15<= and <20 years old)

Key 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.

Target sample size

16

Name of lead principal investigator

1st name	Tsuyoshi
Middle name
Last name	Tsuyoshi Murase

Organization

Osaka University Graduate School of Medicine

Division name

Department of Orthopaedic Surgery

Zip code

565-0871

Address

2-2, Yamada-Oka, Suita, Osaka

TEL

06-6879-3552

Email

tmurase-osk@umin.ac.jp

Name of contact person

1st name	Tatsuhiro
Middle name
Last name	Tatsuhiro Hanai

Organization

Osaka University Graduate School of Medicine

Division name

Department of Orthopaedic Surgery

Zip code

565

Address

2-2, Yamada-Oka, Suita, Osaka

TEL

06-6879-3552

Homepage URL

Email

t-hanai@hss.osaka-u.ac.jp

Institute

Osaka University

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Nagoya University Graduate School of Medicine

Name of secondary funder(s)

None

Organization

IRB Osaka University

Address

2-15. Yamada-oka, Suita, Osaka

Tel

06-6879-6551

Email

irb-jimu@hp-mctr.med.osaka-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大阪大学医学部附属病院（大阪府）(Osaka University Hospital)
名古屋大学医学部附属病院（愛知県）(Nagoya University Hospital)

Date of disclosure of the study information

2014

Year

08

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Purpose: We aimed to prospectively verify the efficacy and safety of patient-matched surgical guides and implants in corrective osteotomy for deformities of the upper extremity so that they can be used as an advanced medical instrument.
Method: We enrolled 16 patients with 17 upper extremity bone deformities. All cases underwent 3-D corrective osteotomy with patient-matched surgical guide and plate. While the primary outcome was assessment of the maximum deformity angle (MDA), secondary outcomes were to calculate the deformity angle on two-dimensional plain radiographs, 3-D error between preoperative planning and postoperative result, clinical status [range of motion, grip strength, and pain with the visual analog scale (VAS)], and self-reported function system using Disabilities of the Arm, Shoulder, and Hand (DASH).
Results: The average MDA significantly improved from 25.5 degrees to 3.3 degrees (p < 0.001). The angular deformity of the normal side in two-directional radiographs was within 10 degrees in all cases. The correction error between the postoperative 3D bone model and planning was <1 degree and 1 mm. The range of motion of adjacent joints improved. Average VAS significantly reduced from 2.41 to 0.26 (p < 0.001). The ratio of grip strength to contralateral normal side was significantly increased from 78.1% to 90.74% (p < 0.001). The average DASH score significantly improved from 21.3 to 7.8 (p < 0.001). We reported no major complications related to the present surgery.
Conclusions: Corrective osteotomy using the patient-matched surgical guide and plate could attain accurate correction and good functional recovery in the upper extremity. The novel 3-D corrective osteotomy could benefit patients with bone deformity and contribute to standardizing complicated surgery.

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2013

Year

10

Month

02

Day

Date of IRB

Anticipated trial start date

2015

Year

01

Month

01

Day

Last follow-up date

2017

Year

05

Month

19

Day

Date of closure to data entry

2018

Year

02

Month

07

Day

Date trial data considered complete

2018

Year

02

Month

08

Day

Date analysis concluded

2018

Year

03

Month

07

Day

Other related information

Registered date

2014

Year

08

Month

11

Day

Last modified on

2019

Year

08

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014053