Clinical Results of Minimally Invasive Plate Osteosynthesis Versus Conventional Approach in Volar Locking Plate for Close Fractures of Distal End Radius Under WALANT
Phase: NA
Conditions: Radius; Fracture, Lower or Distal End
Sponsor: Police General Hospital, Thailand

[Unique Protocol ID: Dh3108103/64] (October 5, 2021) 
Official Title: Clinical Results of Minimally Invasive Plate Osteosynthesis Versus Conventional Approach in Volar 
Locking Plate for Close Fractures of Distal End Radius Under WALANT   
1 
Study protocol 
Material and Methods  
1. Patient 
The Consolidated Standards of Reporting Trials (CONSORT) statement guidelines were followed in this single-
center, prospective, parallel group, assessor-blinded, randomized controlled trial. All procedures were approved by 
the institutional review board of Police general hospital.  
 
Patients who were diagnosed isolated closed fracture of distal end radius at Police General Hospital, Bangkok, 
Thailand between October 2021 and February 2023 were divided into the conventional group and the MIPO group 
at recruitment, using a computer-generated randomization program from www.randomizer.org. Patients were 
informed about the treatment options during a pre-interviewing session, and all eligible patients gave their written 
informed consent before the randomization and initialization of the allocated treatment. When patients arrived in 
the operating room, randomization took place using sealed envelopes containing assigned numbers. These 
envelopes were in the operating room and remained unopened until the patient's arrival. Neither the patient nor 
the attending physicians were informed about the randomization process. The orthopedic surgeon who assessed 
patient eligibility was not involved in randomization, thereby securing allocation concealment. 
  
Inclusion criteria: 
-We included those diagnosed with isolated closed fractures of the distal end radius requiring surgery,  
-aged 18 years and older. 
The Exclusion criteria were:  
(1) Patients with bone fractures lasting more than 21 days 
(2) open fractures 

[Unique Protocol ID: Dh3108103/64] (October 5, 2021) 
Official Title: Clinical Results of Minimally Invasive Plate Osteosynthesis Versus Conventional Approach in Volar 
Locking Plate for Close Fractures of Distal End Radius Under WALANT   
2 
(3) articular multifragmentary comminuted fractures of the distal radius categorized as AO/OTA 2R3C3 
(4) not suitable to undergo volar approach surgery 
(5) individuals with combined carpal fractures or dislocation 
(6) ulna fractures 
(7) associated injuries 
(8) a history of previous wrist surgery 
(9) diabetes mellitus 
(10) chronic wrist inflammation 
(11) wrist bone deformities 
(12) the use of anticoagulation drugs 
(13) uncooperative behavior 
(14) those refusing to participate in the research 
 
2. Methods 
According to the WALANT solution in our institute (Jaroenporn et al., 2022), the steps for preparing the solution 
are as follows (Figure 2A). Firstly, 40 ml of 1% Lidocaine with adrenaline (1:100,000) and 10 ml of 0.5% Marcaine 
are added to the solution. Marcaine, a long-acting local anesthetic, helps prolong the duration of pain relief. 
Additionally, 40 ml of Normal Saline Solution (NSS) is included; NSS acts as a diluent and ensures the appropriate 
volume of the anesthetic solution. Finally, 4 ml of 7.5% NaHCO3 (sodium bicarbonate) is added to balance the acid-
base pH. By following these steps, a total solution volume of 94 ml is prepared.  
 

[Unique Protocol ID: Dh3108103/64] (October 5, 2021) 
Official Title: Clinical Results of Minimally Invasive Plate Osteosynthesis Versus Conventional Approach in Volar 
Locking Plate for Close Fractures of Distal End Radius Under WALANT   
3 
All patients underwent volar locking plate fixation under WALANT. First, the periosteum of the radius is infiltrated 
at three different points: proximal, middle, and distal (radial styloid), with each point receiving 10 ml of anesthesia. 
This ensures that the circumferential periosteum of the radius bone is adequately anesthetized. Next, a 
subcutaneous infiltration along the volar skin incision of 10 ml is injected (Figure 2B). After a 30-minute period of 
allowing the anesthesia to take effect  
 
Operative Procedure for MIPO: 
 
The patient, under WALANT, was in the supine position on the surgical table. A minimal 2 cm skin incision was 
made on the volar side of the wrist, proximal to the wrist crease 2 cm. The Trans flexor carpi radialis approach 
(Trans FCR) was performed, and the surgical plane was dissected using curved scissors to increase exposure. To 
mobilize and protect the flexor carpi radialis (FCR) and flexor pollicis longus (FPL) ulnarly, a self-retractor was 
employed. Care was taken to avoid damaging the radial artery on the radial side and the palmar cutaneous branch 
of the median nerve on the ulnar side. The distal aspect of the pronator quadratus muscle was elevated using a 
periosteal elevator. A partial transverse cut was made in the pronator quadratus muscle at the distal end to 
approach the fracture site. Closed reduction and temporary fixation with K-wires were used to assist in the 
reduction. The alignment was checked under fluoroscopy. The DePuy Synthes VA-LCP Two-Column Distal Radius 
Plates 2.4, volar, narrow, with 6 head holes and a width of 19.5 mm (Synthes USA Products, LLC), were utilized in 
the procedure. These plates were chosen for their minimal width, allowing easy insertion through a small incision. 
One cortical screw was inserted into an elongate hole, followed by the insertion of 4 distal locking screws. An 
additional proximal vertical mini incision of 1 cm was made for fixation with 2 proximal locking screws. No drain 
was inserted, and cast immobilization was not required. 
 
 

[Unique Protocol ID: Dh3108103/64] (October 5, 2021) 
Official Title: Clinical Results of Minimally Invasive Plate Osteosynthesis Versus Conventional Approach in Volar 
Locking Plate for Close Fractures of Distal End Radius Under WALANT   
4 
Post-operation: 
Adhering to post-operative protocols, no drain was inserted, and cast immobilization was unnecessary. Immediate 
encouragement of active finger and wrist motion was provided after the operation. Both groups were 
administered pain medication for 7 days, including Tramadol (50 mg), 1 tablet three times daily; Naproxen (250 
mg), 1 tablet twice daily; and Tolperisone (50 mg), 1 tablet three times daily. In cases where the patient's Visual 
Analog Scale (VAS) pain score exceeded 5, a 3 mg IV dose of morphine was administered as needed by the patient. 
As part of their early post-operative rehabilitation, patients were instructed in the six-pack exercise and wrist 
range of motion (ROM) exercises. 
 
 
 

[Unique Protocol ID: Dh3108103/64] (October 5, 2021) 
Official Title: Clinical Results of Minimally Invasive Plate Osteosynthesis Versus Conventional Approach in Volar 
Locking Plate for Close Fractures of Distal End Radius Under WALANT   
5 
3. Evaluation 
The data collector, an orthopedic resident unaware of the surgical technique used, obtained information. Neither 
the collector nor the patients observed the surgical incision. 
 
The primary outcome was measured using the pain visual analogue scale (VAS). Regarding the pain VAS, a score of 
0 indicated no pain, and a score of 10 indicated the worst imaginable pain. The pain VAS score was recorded in the 
morning first 7 day then in the 2nd, 6th, 10th, 14th, and 24th weeks after surgery. 
 
Patients attended outpatient department (OPD) follow-up appointments in the 2nd, 6th, 10th, 14th, and 24th 
weeks after surgery. The Quick Disabilities of the Arm, Shoulder, and Hand (Quick DASH) score indicated a 
functional outcome. The patient's satisfaction, along with the cosmetic score (rating the scar's appearance on a 
scale of 0 to 5, with 5 being excellent),. Hand grip strength was measured as a percentage of the strength in the 
other hand using a baseline hydraulic hand dynamometer with a JAMAR device (lbs force) from Sammons Preston, 
Inc., Bolingbrook, IL 60440-4989, in a 90 degree raised and extended arm position. The patient squeezed the 
dynamometer three times, and the highest score was recorded. Pinch strength was assessed by raising the 
patient's arm in front of them and bending it at a 90-degree angle, testing with a JAMAR Hydraulic Pinch Gauge. 
Three pinches on the device provided the highest score. 
 
 
 

[Unique Protocol ID: Dh3108103/64] (October 5, 2021) 
Official Title: Clinical Results of Minimally Invasive Plate Osteosynthesis Versus Conventional Approach in Volar 
Locking Plate for Close Fractures of Distal End Radius Under WALANT   
6 
4 Statistical Analysis 
IBM SPSS Statistics 27.0 was utilized for statistical analysis. Results were expressed as the mean ± standard 
deviation. Statistically significant differences were determined based on P < 0.05 and the 95% confidence interval 
(CI). The Fisher's exact test was used to evaluate baseline characteristics including sex, fracture side, cause, 
AO/OTA type. The paired t-test was used to evaluate the age, incision length, VAS pain score, Quick DASH, 
functional outcomes (grip, pinch strength, range of motion), operative time, Aesthetics, Satisfaction and 
radiographic parameters. All subjects were analyzed and none of the subjects were lost to follow-up. 
 
 
 

[Unique Protocol ID: Dh3108103/64] (October 5, 2021) 
Official Title: Clinical Results of Minimally Invasive Plate Osteosynthesis Versus Conventional Approach in Volar 
Locking Plate for Close Fractures of Distal End Radius Under WALANT   
7 
CONSORT diagram 
 
 
 
 
Allocation 
Assessed for eligibility (n=68) 
Excluded (n=2) 
Not meeting inclusion criteria (n=2) 
Declined to participate (n=0)
Analysed (n=33) 
Lost to follow-up (n=0) 
Allocated to intervention (n=33) 
Received allocated intervention (n=33) 
Did not receive allocated intervention 
(n=0)
Lost to follow-up (n=0) 
Allocated to intervention (n=33) 
Received allocated intervention (n=33) 
Did not receive allocated intervention 
(n=0)
Analysed (n=33) 
Randomized (n=66) 
Follow-up 
Analysis 
Enrollment 

[Unique Protocol ID: Dh3108103/64] (October 5, 2021) 
Official Title: Clinical Results of Minimally Invasive Plate Osteosynthesis Versus Conventional Approach in Volar 
Locking Plate for Close Fractures of Distal End Radius Under WALANT   
8 
Method 
 
 
 
 
 
 
Setting : 
•
Police General Hospital, Thailand
•
October 2021 - February 2023
Close Fracture of 
Distal Radius
Conventional
MIPO
Post-operative Pain at day 0-7
Follow-up OPD at week 2 , 6 , 10 , 14 , 24
Exclusion
•
Fracture > 21 days
•
AO type-B2 , C3
•
Previous wrist fracture or 
deformity
•
DM
•
Chronic wrist inflammation
•
Coagulopathy
•
Declined to participate
Randomized
Inclusion 
•
Isolated close distal radius 
fracture
•
> 18 years old
Post-op Pain Control Protocol
•
Tramadol (50) 1 x 3 po pc
•
Toperisone 1 x 3 po pc
•
Morphine 3 mg IV prn q 4 hrs
•
(If VAS score is >5)

[Unique Protocol ID: Dh3108103/64] (October 5, 2021) 
Official Title: Clinical Results of Minimally Invasive Plate Osteosynthesis Versus Conventional Approach in Volar 
Locking Plate for Close Fractures of Distal End Radius Under WALANT   
9 
Data collection process 
1) Pain Visual Analog Score 
 
 
 
 
 
 
Postoperative day 
date 
Pain VAS 
0 
 
 
1 
 
 
2 
 
 
3 
 
 
4 
 
 
5 
 
 
6 
 
 
7 
 
 

[Unique Protocol ID: Dh3108103/64] (October 5, 2021) 
Official Title: Clinical Results of Minimally Invasive Plate Osteosynthesis Versus Conventional Approach in Volar 
Locking Plate for Close Fractures of Distal End Radius Under WALANT   
10 
2) QuickDASH form 
 
 
 
 

[Unique Protocol ID: Dh3108103/64] (October 5, 2021) 
Official Title: Clinical Results of Minimally Invasive Plate Osteosynthesis Versus Conventional Approach in Volar 
Locking Plate for Close Fractures of Distal End Radius Under WALANT   
11 
3) Table data collection 
 
 
MIPO 
Conventional 
p-value 
Mean age, (SD); range  
 
 
Sex 
 
 
 
  female 
 
 
 
  male 
 
 
 
fracture side 
 
 
 
  Dominant Hand 
 
 
 
  Non-dominant Hand 
 
 
 
Cause 
 
 
 
  fall 
 
 
 
  road traffic accident 
 
 
 
  sports 
 
 
 
AO/OTA 23 
 
 
 
  A2 
 
 
 
  A3 
 
 
 
  B3 
 
 
 
  C1 
 
 
 
  C2 
 
 
 
 
 
 
 
 

[Unique Protocol ID: Dh3108103/64] (October 5, 2021) 
Official Title: Clinical Results of Minimally Invasive Plate Osteosynthesis Versus Conventional Approach in Volar 
Locking Plate for Close Fractures of Distal End Radius Under WALANT   
12 
 
 
  
wk 2 
wk 6 
wk 10 
wk 14 
wk 24 
   (lbs) 
F/U 1 
F/U 2 
F/U 3 
F/U 4 
F/U 5 
  Grip strength Fx 
  
  
  
  
  
  Grip strength normal 
  
  
  
  
  
  Pinch strength Fx 
  
  
  
  
  
  Pinch strength normal 
  
  
  
  
  
  ROM Fx 
  
  
  
  
  
 Flexion 
  
  
  
  
  
 Extension 
  
  
  
  
  
 Supination 
  
  
  
  
  
 Pronation 
  
  
  
  
  
 Radial deviation 
  
  
  
  
  
 Ulnar deviation 
  
  
  
  
  
  
  
  
  
  
  
Pain (0-10) 
  
  
  
  
  
QuickDASH  
  
  
  
  
  
Wound size (mm) 
  
  
  
  
  
Cosmetic score 
 
 
 
 
 
Satisfy score 
 
 
 
 
 

[Unique Protocol ID: Dh3108103/64] (October 5, 2021) 
Official Title: Clinical Results of Minimally Invasive Plate Osteosynthesis Versus Conventional Approach in Volar 
Locking Plate for Close Fractures of Distal End Radius Under WALANT   
13