Journal List > Arch Hand Microsurg > v.23(2) > 1106615

Cha and Shin: Effects of a Temperature-sensitive, Anti-adhesive Agent on the Clinical Outcome of Carpal Tunnel Release Surgery

초록

Purpose:

We investigated the antiadhesive effects of a temperature-sensitive poloxamer/alginate mixture (Guardix-SG®; Hanmi Medicare Inc., Korea) through a prospective randomized controlled study for carpal tunnel release surgery.

Methods:

The 47 patients who received the infusion were classified as Group 1, and the 51 patients who did not were classified as Group 2. Basic demographic factors and preoperative clinical status were evaluated. At the postoperative 18 months, the degree of clinical recovery and adhesion around the median nerve for both groups were evaluated and compared using sonography.

Results:

The clinical outcomes, which were assessed using the six-item carpal tunnel symptoms scale, were not signifi-cantly different between the groups. However, sonography showed that adhesions around the median nerve were signifi-cantly less common in the infusion group.

Conclusion:

Although the antiadhesive effects of the temperature-sensitive Guardix-SG® were apparent upon radio-logical investigation, its use was not associated with a significant difference in clinical outcome on the short-term period follow-up.

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Fig.1.
Flow diagram for our randomized controlled study.
ahm-23-126f1.tif
Fig.2.
Measurement of the distance between the median nerve and the centre of the scaphoid tubercle. First, we identified the floor of the carpal tunnel made by the carpal bones on the images and found the view with the maximal contour of the tubercle of the scaphoid and pisiform. This view was defined as the adequate image for evaluation of the median nerve mobility. (A) The maximal distance between the median nerve and the scaphoid tubercle was measured with the wrist deviated radially and all fingers extended, in this patient. (B) The minimal distance between the median nerve and the scaphoid tubercle was checked with the wrist held in a neutral position while all four fingers and the thumb were maximally flexed. The differences between the measurements were taken as median nerve movement.
ahm-23-126f2.tif
Table 1.
Major Standard Occupational Classification 2010 groups and example occupations
Category Major occupational group Example
1 Managers, directors, and senior officials Chief executives, senior officials, managers in finance, transport, health, social services
2 Professional occupations Doctors, lawyers, teachers, nurses, social workers, journalists
3 Associate professional and technical occupations Science, engineering, production technicians, IT technicians
4 Administrative and secretarial occupations Book keepers, national government administrators, clerks, secretaries
5 Skilled trades occupations Agriculture, fabrication, machining, transport technicians, electricians, plumbers, construction workers
6 Caring, leisure, and other service occupations Childcare, nursing auxiliaries, dental nurses, travel agents, hairdressers, beauticians, caretakers
7 Sales and customer service occupations Cashiers, telephone sales, call centre technicians
8 Process, plant, and machine operatives Machine operatives, train drivers, fork-lift truck operators, taxi drivers, bus drivers
9 Elementary occupations Farm workers, cleaners, refuse and salvage occupations, security guards, parking attendants, porters
Table 2.
Basic demographic data between two groups
Variable Group 1 Group 2 p-value
Age at diagnosis (yr) 58.21±10.84 56.75±7.89 0.44
Sex (Male:Female) 16:31 9:42 0.07
Onset period of symptoms or signs (mo) 15.30±3.49 15.90±2.48 0.32
The time from the diagnosis to the surgery (mo) 6.72±0.80 6.73±0.72 0.99
Site of the lesion (Dominant: Non-dominant) 26:21:00 22:29 0.31

Values are presented as mean±standard deviation or number.

Table 3.
Differences in the occupational distributions between the two groups
Category p-value
1 2 3 4 5 6 7 8 9
Group 1 1 3 3 9 11 13 4 3 0 0.14
Group 2 0 7 11 9 8 8 2 3 3

Values are presented as only number.

Table 4.
Comparisons of the preoperative electrodiagnosis graded by the Bland scale
Scale p-value
2 3 4
Group 1 7 26 14 0.77
Group 2 9 30 12  

Values are presented as only number.

Table 5.
Comparisons of clinical items using the Graham criteria
Item Preoperative state/ final follow-up Group 1 Group 2 p-value
Numbness or tingling (+)/(+) 6 1 0.08
  (+)/(–) 41 49  
  (–)/(–) 0 1  
Nocturnal numbness (+)/(+) 0 0 0.23
  (+)/(–) 45 51  
  (–)/(–) 2 0  
Thena atrophy (+)/(+) 14 9 0.37
  (+)/(–) 4 5  
  (–)/(–) 29 37  
Tinel (+)/(+) 18 14 0.06
  (+)/(–) 21 34  
  (–)/(–) 8 3  
Phalen (+)/(+) 20 17 0.49
  (+)/(–) 19 21  
  (–)/(–) 8 13  
Improvement of two-point discrimination (Preoperative TPD-final TPD)        
 Thumb (mm)   0.94±0.82 1.25±1.28 0.14
 Index (mm)   1.11±0.91 1.43±0.85 0.07
 Long finger (mm)   1.04±1.04 1.37±1.17 0.14
 Ring finger (mm)   0.86±0.12 1.00±0.75 0.33

Values are presented as number or mean±standard deviation.

Table 6.
Comparisons of clinical and radiologic outcomes
Clinical and radiologic outcome Group 1 Group 2 p-value
Improvement of Clinical outcomes (Preoperative scores-final scores)      
 Boston Symptom Scores 17.16±6.41 18.58±3.64 0.19
 Boston Function Scores 9.16±4.08 8.93±2.77 0.11
Sonographic measurement at final follow-up (mm)      
 Maximal distance of median nerve 16.2±8.4 16.4±7.1 0.25
 Minimal distance of median nerve 12.9±11.6 15.2±8.5 <0.001
 Movements of median nerve 3.3±1.1 1.2±7.7 <0.001

Values are presented as mean±standard deviation.

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