Ultrasound-Guided A1 Pulley Release Versus Classic Open Surgery for Trigger Digit: A Randomized Clinical Trial.

OBJECTIVES: We compared an ultra-minimally invasive ultrasound-guided percutaneous A1 pulley release and a classic open surgery for trigger digit. METHODS: We designed a single-center randomized control trial. All cases had clinical signs of primary grade III trigger digit. Concealed allocation (1:1) was used for assigning patients to each group and data collectors were blinded. The Quick-Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) questionnaire was our primary variable. Quick-DASH, two-point discrimination, grip strength, time until stopping analgesics, having full digital range of motion and restarting everyday activities were registered on the 1st, 3rd, and 6th weeks, 3rd and 6th months, and 1st year after the procedure. RESULTS: We randomized 84 patients to ultrasound-guided release and classic open surgery. Quick-DASH scores significantly favored the percutaneous technique until the 3rd month: 7.6 ± 1.2 versus 15.3 ± 2.4 (mean ± standard error of the mean). The percutaneous group obtained significantly better results in all the variables studied: time until stopping analgesics, achieving full range of motion and restarting everyday activities. Grip strength was significantly better in the percutaneous group for the 1st week only. Five cases of moderate local pain were observed in the open technique. There was one case of transient nerve numbness per group. CONCLUSIONS: The ultra-minimally invasive ultrasound-guided A1 pulley release was clinically superior to the classic open surgery in functional recovery with a lower complication rate.

Ultra-minimally Invasive Sonographically-guided Trigger Digit Release: An External Pilot Study.

Objectives: The most common surgical option for releasing the first annular pulley in trigger digit (TD) is classic open surgery followed by blind percutaneous release. However, they have been related to major complications and incomplete releases, respectively. Intrasheath sonographically-guided first annular pulley release has recently been shown to be safe and effective in every digit. The objectives of this pilot study were to preliminary compare clinically an intrasheath sonographically-guided first annular pulley release versus a classic open technique and to evaluate the feasibility of a future clinical trial in patients with TDs. Methods: Thirty patients were randomized 1:1 in an external pilot study comparing the two surgical techniques: a percutaneous sonographically-guided release performed through a 1 mm incision using a hook knife versus a classic open surgery with a 1 cm incision. Inclusion criteria were primary TD grade III (Froimson). We defined success if primary (safety and efficacy) and secondary (recruitment rates, compliance, completion, treatment blinding, personnel resources, and sample size calculation for the clinical trial) objectives could be matched. We registered the grip strength, the QuickDASH score and a set of postoperative clinical variables at one, three, and six weeks and at three months. We calculated the sample size for the clinical trial using the QuickDASH at the end of the follow-up. Outcomes assessors were blinded. Results: All patients in both groups showed resolution of their symptoms with no associated complications or relapses. Secondary feasibility objectives were matched: 76.9% of eligible patients were included in the study, 3.3% refused randomization, 20 patients per month were recruited, 100% received blinded treatment, 98.5% showed compliance, and 100% completed the study. The sample size for a future clinical trial was 84 patients. There were no differences in grip strength. The intrasheath sonographically-guided first annular pulley release showed significantly better QuickDASH scores, until the sixth postoperative week. Conclusions: The intrasheath sonographically-guided first annular pulley release is safe and efficacious, and shows a trend toward clinical superiority versus the classic open procedure, which should be confirmed with a clinical trial. Our study shows that a randomized clinical trial is feasible.

Ultra-Minimally Invasive Ultrasound-Guided Carpal Tunnel Release: A Randomized Clinical Trial.

OBJECTIVES: The purpose of this study was to compare the outcomes of 1-mm ultra-minimally invasive ultrasound-guided carpal tunnel release and 2-cm blind mini-open carpal tunnel release. METHODS: We conducted a single-center individual parallel-group controlled-superiority randomized control trial in an ambulatory office-based setting at a third-level referral hospital. Eligible participants had clinical signs of primary carpal tunnel syndrome and positive electrodiagnostic test results and were followed for 12 months. Independent outcome assessors were blinded. Patients were randomized by concealed allocation (1:1) by an independent blocked computer-generated list. The postoperative score on the Quick-Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire was the primary variable. Grip strength and time for discontinuation of oral analgesics, complete wrist flexion-extension, relief of paresthesia, and return to normal daily activities (including work) were assessed. RESULTS: Ninety-two of 128 eligible patients were randomly allocated and analyzed. QuickDASH scores were 2.2 to 3.3 times significantly lower in the ultra-minimally invasive group for the first 6 months: 23.6 [95% confidence interval (CI), 20.5, 27.4] versus 52.6 [95% CI, 49.4, 57.0] at the first week and 4.09 [95% CI, 1.5, 7.1] versus 13.0 [95% CI, 9.4, 18.9] at 6 months. Return to normal daily activities occurred significantly sooner in the ultra-minimally invasive group: 4.9 [95% CI, 3.2, 6.5] versus 25.4 [95% CI, 18.2, 32.6] days. CONCLUSIONS: Ultra-minimally invasive carpal tunnel release provides earlier functional return and less postoperative morbidity with the same neurologic recovery as mini-open carpal tunnel release for patients with symptomatic primary carpal tunnel syndrome.

Ultra-minimally invasive sonographically guided carpal tunnel release: anatomic study of a new technique.

OBJECTIVES: The purposes of this study were to measure a safe zone and a path for ultra-minimally invasive sonographically guided carpal tunnel release with a 1-mm incision in healthy volunteers and then test the procedure in cadavers. METHODS: First, a previously reported sonographic zone was defined as the space between the median nerve and the closest ulnar vascular structure. Axially, the safest theoretical cutting point for carpal tunnel release was set by bisecting this zone. Magnetic resonance imaging was used for axially determining the limits of the sectors (origin at the cutting point) that did not enclose structures at risk (arteries and nerves) and coronally for determining whether our release path could require directions that could potentially compromise safety (origin at the pisiform's proximal pole). Second, in cadavers, we performed ultra-minimally invasive sonographically guided carpal tunnel release from an intracarpal position through a 1-mm antebrachial approach. Efficacy (deepest fibrous layer release rate), safety (absence of neurovascular or tendon injury), and damage to any anatomy superficial to transverse carpal ligament were assessed by dissection. RESULTS: All 11 of our volunteers (22 wrists) had safe axial sectors located volar and radially of at least 80.4º (considered safe). Release path directions were theoretically safe (almost parallel to the longitudinal axis of the forearm). In 10 cadaver wrists, ultra-minimally invasive sonographically guided carpal tunnel release was effective (100% release rate) and safe without signs of intrusion into the superficial anatomy. CONCLUSIONS: Ultra-minimally invasive sonographically guided carpal tunnel release in a safe sonographic zone may be feasible The technique preserves the superficial anatomy and diminishes the damage of a surgical approach.

Selective 360° percutaneous extensor carpi radialis brevis tendon release for tennis elbow: an experimental study.

OBJECTIVES: The purpose of this study was to define in volunteers and cadavers the positions of structures at risk and the extensor carpi radialis brevis (ECRB) origin limits for sonographically guided percutaneous tendon release in tennis elbow. METHODS: First, in volunteers, we used Doppler sonography to determine the position (danger zone) of the structures at risk (neurovascular bundle and radial collateral ligament) from the most lateral point of the epicondyle (point of entry). Second, in cadavers, we studied the footprint of the ECRB's origin for finally performing sonographically guided tendon release (1- to 2-mm incision) away from the danger zone. Efficacy was measured in terms of detachment ratios for the ECRB and safety as the absence of neurovascular bundle or radial collateral ligament injuries. RESULTS: In 10 volunteers (20 elbows), the neurovascular bundle was located 18.1 mm or greater anteromedially from the point of entry. The neurovascular bundle was not in direct contact with the bone. In 13 formaldehyde-embalmed cadaver elbows, the distance between the origin of the ECRB and the radial collateral ligament was 0 mm or greater. The anterior origin of the ECRB did not contact the neurovascular bundle. The maximum attachment limits of the ECRB were at 15, 5, 15, and 16 mm from the point of entry (anterior, posterior, proximal, and distal margins, respectively). Average detachment ratios were excellent for anterior and distal margins and good for posterior and proximal margins, without neurovascular bundle or radial collateral ligament injuries. CONCLUSIONS: This study determined a danger zone to avoid and an area of probability in which to enclose most of the ECRB's origin for sonographically guided percutaneous tendon release. A 360° ECRB detachment can be performed safely and effectively. Clinically, sonographically guided percutaneous tendon release should selectively target pathologic regions.

Sonographically guided intrasheath percutaneous release of the first annular pulley for trigger digits, part 1: clinical efficacy and safety.

OBJECTIVES: For trigger digits, intrasheath sonographically guided first annular (A1) pulley release has shown safety and effectiveness in cadavers. This clinical study describes sonographically guided A1 pulley release results in terms of resolution of symptoms, safety, and functional recovery. METHODS: Sonographically guided A1 pulley release (11-MHz probe) was used in 48 digits of 48 patients prospectively followed for 11.3 months and examined 1, 3, and 6 weeks, 3 and 6 months, and 1 year later. Resolution of triggering (primary variable of interest) was expressed as the "success rate" per digit. The time for taking postoperative pain killers, range of motion recovery, grip strength, QuickDASH test scores, return to normal activities (including work), cosmetic results, satisfaction, and complications were assessed. RESULTS: The success rate was 100%, and no cases recurred. Mean times were 1.9 days for taking pain killers, 6.6 days for returning to normal activities, and 9.9 and 3.8 days for complete extension and flexion recovery, respectively. Mean QuickDASH scores were 39.8 preoperatively and 7.8, 1.7, and 0 after 6 weeks, 6 months, and 1 year postoperatively. Grip strength reached greater than 90% of the individual's normal strength by the sixth week in men and by the third month in women (P < .001). Radial digital nerve numbness developed in 1 finger, which disappeared by the third week. No other complications were noted. All wounds were cosmetically excellent, and final satisfaction was excellent or good in 98%. CONCLUSIONS: With adequate anatomic knowledge, technical training, and a basic ultrasound machine, sonographically guided A1 pulley release can be performed safely and successfully, offering an alternative to classic open surgery in the ambulatory setting.