- Purpose : For evaluating the efficiency of 3D-printed patient specific orthopaedic fixation plates for patients with distal radius fractures or patients in need of corrective osteotomy.

- Background of research:
 Most domestic radial plates are second-rate products which are too thick to put on the front side of the radial bone even though the shape was fitted in. As a result, radial plates can irritate the flexor pollicis longus, which may lead to tendon rupture as a complication. For this reason, it is important to custom-design, assemble and apply plates for each individual patient. 
 In addition, this custom-designed plates are also helpful in the event of re-operation due to malunion fractures or osteotomy for kienbock disease since it is completely fitted with patient’s bone shape. The patients with these kinds of disease often have some problems which are caused by unfitted ready-made plates. If the fixation plates are designed for exactly same with each patient’s bone shape, it will be expected that operation time is shortened and the fit is stronger than normal products.
 Three-dimensional printing technique is producing real products based on 3D design/plan. The extent of using 3D printing technique is getting broaden in medical field. Especially, in the orthopaedics field, it used to be used for producing medical appliances before but, it has expanded to produce custom-made fixation for hip or limbs and so on over past few years. Nevertheless, in case of distal radius fractures or kienbock disease, there are only few standard studies like producing fixation or applying plates in few cases so far. In conclusion, 3D-printed patient specific orthopaedic fixation plates for distal radius fractures or kienbock disease should be studied more.

- Plan for clinical research
 This study is aimed at hospitalized patients who are over 19 and under 70 years of age, diagnosed as distal radial fractures, malunion followed by distal radial fractures and needed osteotomy after kienbock disease diagnosis. Before the operation with this special radius plate, we will take a 3D-CT scan of the patient’s radius. After that, we will arrange the production of the 3D-printed radial plate which will be exactly suited to the patient's radius. Following the operation, there will be clinical outpatient treatments as regular check-ups on the 2nd, 4th, 6th, 8th, 12th, and 24th weeks, taking X-rays each time. Plus, on the 12th and 24th weeks, there will be CT scans to check on the bone union. Lastly, DASH (disabilities of arm, shoulder & hand) and PRWE (patient-rated wrist evaluation) questionnaires will be requested to be filled out by patients on the 12th and 24th weeks. For any patient who drops out, data collection from that patient will be halted from the moment they do, but all data collected before and after dropouts will be included in statistical analysis.

Others

(Academic)

Product the specific plate by taking an 3D-CT scan on appropriate part for the patient. In a distal radius fractures patient case, it is able to use 3D-printed patient specific orthopedic fixation plate, if the patient got an open reduction and internal fixation or corrective osteotomy.

Arm Label

Target Number of Participant

Arm Type

Arm Description

Making custum plates by taking an 3D-CT scan on appropriate part for the patients. In distal radius fractures patients case, it is able to use 3D-printed patients specific orthopedic fixation plate, if the patients got an open reduction and internal fixation or corrective osteotomy.

Gender

Age

Description

1) From 02.04.2021 to 05.31.2022, patients who visit Seoul asan medical center outpatient clinic or emergency room and with distal radius fractures or patients in need of corrective osteotomy
2) Patients aged over 19 to 70 years of age who have heard and understood the explanation of this study and consented in writing.

1) Patients who had operation on same part
2) Patients who are susceptible to delayed recoveries due to some conditions, such as alcoholism or metabolic diseases.
3) Patients who are pregnant or lactating women.
4) Patients who are considered having difficulties to involve in this study by principal investigator

1) Recovery period to bone union (X-ray, CT scan)

1)X-rays are taken on the 2nd, 4th, 6th, 8th, 12th, and 24th weeks, and CT scans on the 12th and 24th weeks, following the operation.

2) DASH and PRWE questionnaires

2)DASH and PRWE questionnaires are taken on the 12th and 24th weeks following operation,

3) Wrist range of motion

3) Wrist ROM is evaluated on the 12th and 24th weeks following the operation

4) Grip strenth

4) Grip strength is evaluated on the 12th and 24th weeks followed by the operation

Demographical characteristics(ex. age, height, weight etc.)

Before the operation

underlying conditions

Before the operation

medical history

Before the operation

dominant hand or not

Before the operation

pre-op blood test

Before the operation