Concomitant Basal Joint Arthroplasty and Carpal Tunnel Release

Carpal Tunnel Syndrome Clinical Trial

Official title:

Basal Joint Arthroplasty and Carpal Tunnel Release Comparing Single Versus Double Incision. Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04391751
• Other study ID #: PR(ATR)147/2018
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: May 2020
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Concomitant carpal tunnel syndrome and basal thumb junt osteoarthritis through a single incision has been described. Case serials have reported good with this technique. Nonetheless, there is a lack of comparative studies evaluating the effectivity and complications of single-incision versus double-incision technique. Only with an randomized clinical trial design it is possible to gain evidence about the advantages of one treatment method over another. The aim of the study is the comparison between two surgical techniques for concomitant carpal tunnel syndrome and basal thumb junt osteoarthritis: single versus double incision techniques.

Description:

Basal thumb joint osteoarthritis is a common disorder especially among postmenopausal women. In this specific subgroup of patients, radiographic signs appear in up to 40%.

Approximately 28% of those cases are symptomatic. Its pathoanatomy and treatment has been well described. Trapeziometacarpal joint is the most commonly joint requiring treatment for osteoarthritis in the upper extremity, often involving removing the trapezius. The same demographic group is also frequently affected by carpal tunnel syndrome (CTS), which coexists with basal joint arthritis in 18% to 46% of patients. In those cases, a combined surgical approach has been reported to be beneficial. The two conditions have traditionally been treated surgically through separate incisions.

a radial incision for trapeziectomy and standard midline volar carpal tunnel incision for median nerve decompression. Trapeziectomy has been proved to provide some degree of carpal tunnel decompression. However, as previous studies have suggested, release of the transverse carpal ligament should be performed in addition to basal joint arthroplasty incision, as trapeziectomy by itself does not completely decompress the carpal tunnel. The ability to decompress the carpal tunnel during basal joint arthroplasty using a single incision would allow to shorten surgery time, improve appearance, and potentially decrease morbidity compared to a staged or two-incision procedure. We sought to determine whether carpal tunnel release using a single incision during basal joint arthroplasty is as effective as two-incision approach in patients with concomitant CTS and basal thumb joint osteoarthrosis. The secondary hypothesis is that single incision prevents from morbidity associated to a second incision, such as pillar pain, longer surgical procedure, infection rate or necrosis of the skin bridge between incisions

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Concomitant basal joint osteoarthritis and CTS in the ipsilateral extremity.

• Severe CTS sympthoms wiht positive physical examination findings (eg, Phalen test and Tinel test).

• Electromyography (EMG) results supporting the diagnosis of CTS.

• Failed CTS nonsurgical treatment.

• Basal joint osteoarthritis Eaton stage II or greater

• Unacceptable pain localized in the basal joint appeared with activity, or reproduced by grind test or direct palpation

• Failed basal joint osteoarthritis nonsurgical treatment.

Exclusion Criteria:

• Pregnancy

• Diabetes mellitus

• Acute trauma

• Rheumatoid arthritis

• Hipothyroidism

• Hyperthiroidism

• Posttraumatic arthritis

• Prior hand surgery procedures

• Nerve compression at proximal level

• Other nerve entrapments

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Osteoarthritis Thumb

Intervention

Procedure:
• Carpal tunnel release and basal joint arthroplasty through single incision
Group I: experimental - single incision The surgical technique chosen for thumb basal join was trapeziectomy with ligamentous reconstruction and tendon interposition (LRTI), using flexor carpi radialis (FCR). Through a dorsal approach over trapeziometacarpal joint, the entire trapezium was excised. Volar traction of FCR allowed us to longitudinally incise the deep leaflet of FCR tendon until flexor pollicis longus (FPL) tendon was clearly visualized. Then, ulnar half of FCR tendon was harvested proximally through a second transverse incision in middle third of the forearm and split all the way to its insertion on the index metacarpal. A hole was placed in the base of the first metacarpal and FCR tendon was routed through the bone canal and then fixed with non-reabsorbable sutures. Finally, the tendon remanent was rolled up and placed into the trapezial void to act as a spacer.
• Carpal tunnel release and basal joint arthroplasty through double incision
Group II: active comparator - double incision Trapezial excision and ligament reconstruction were performed in the same way as in group I, except that FCR deep leaflet was not incised. After radial incision wound closure, carpal tunnel release was performed through a second separate longitudinal palmar incision.

Locations

Country	Name	City	State
Spain	Ignacio Esteban Feliu	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (8)

Armstrong AL, Hunter JB, Davis TR. The prevalence of degenerative arthritis of the base of the thumb in post-menopausal women. J Hand Surg Br. 1994 Jun;19(3):340-1. — View Citation

Burton RI, Pellegrini VD Jr. Surgical management of basal joint arthritis of the thumb. Part II. Ligament reconstruction with tendon interposition arthroplasty. J Hand Surg Am. 1986 May;11(3):324-32. — View Citation

Cassidy C, Glennon PE, Stein AB, Ruby LK. Basal joint arthroplasty and carpal tunnel release through a single incision: an in vitro study. J Hand Surg Am. 2004 Nov;29(6):1085-8. — View Citation

Eaton RG, Lane LB, Littler JW, Keyser JJ. Ligament reconstruction for the painful thumb carpometacarpal joint: a long-term assessment. J Hand Surg Am. 1984 Sep;9(5):692-99. — View Citation

Geoghegan JM, Clark DI, Bainbridge LC, Smith C, Hubbard R. Risk factors in carpal tunnel syndrome. J Hand Surg Br. 2004 Aug;29(4):315-20. — View Citation

Ingari JV, Romeo N. Basal Joint Arthroplasty and Radial-sided Carpal Tunnel Release Using a Single Incision. Tech Hand Up Extrem Surg. 2015 Dec;19(4):157-60. doi: 10.1097/BTH.0000000000000100. — View Citation

Lutsky K, Ilyas A, Kim N, Beredjiklian P. Basal joint arthroplasty decreases carpal tunnel pressure. Hand (N Y). 2015 Sep;10(3):403-6. doi: 10.1007/s11552-014-9724-9. — View Citation

Weiss AC, Goodman AD. Thumb Basal Joint Arthritis. J Am Acad Orthop Surg. 2018 Aug 15;26(16):562-571. doi: 10.5435/JAAOS-D-17-00374. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complications associated with the different surgical procedures	Complications such as pillar pain, longer surgical procedure, infection rate or necrosis of the skin bridge between incisions	At 2 weeks posteoperatively
Primary	Change of CTS symptoms intensity	To assess the CTS symptoms intensity, patients filled out the Boston Carpal Tunnel Questionaire. This questionnaire evaluates symptom's severity (11 items) and functional status (8 items) (1: no complaints, 5 maximum complaints possible).; Minimum score is 19 and maximum 95.	Preoperatively, 3, 6, and 12 months postoperatively
Secondary	Change of hand function	Hand function was assessed through Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH). Minimum score is 0 (no disability) and maximum 100 (total disability).	Preoperatively, 3, 6, and 12 months postoperatively
Secondary	Change of hand pain	Pain was assessed through 10-visual analog scale. Minimum score is 0 (no pain) and maximum 10 (sever pain).	Preoperatively, 3, 6, and 12 months postoperatively
Secondary	Change of grip strength	Grip strength was measured the mean of 3 attempts, in kilograms, with correction for hand dominance, using a standard dynamometer.	Preoperatively, 3, 6, and 12 months postoperatively