Clinical trial NCT04391751: Concomitant Basal Joint Arthroplasty and Carpal Tunnel Release
Official title: Basal Joint Arthroplasty and Carpal Tunnel Release Comparing Single Versus Double Incision. Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carpal Tunnel Syndrome
Osteoarthritis Thumb
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Change of CTS symptoms intensity
timeFrame: Preoperatively, 3, 6, and 12 months postoperatively
Secondary outcomes:
measure: Change of hand function
timeFrame: Preoperatively, 3, 6, and 12 months postoperatively
measure: Change of hand pain
timeFrame: Preoperatively, 3, 6, and 12 months postoperatively
measure: Change of grip strength
timeFrame: Preoperatively, 3, 6, and 12 months postoperatively
Other outcomes:
measure: Complications associated with the different surgical procedures
timeFrame: At 2 weeks posteoperatively
Locations:
city: Barcelona
country: Spain
facility: Ignacio Esteban Feliu
Study officials:
References:
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citation: Esteban-Feliu I, Gallardo-Calero I, Barrera-Ochoa S, Vidal-Tarrason N, Mir X, Lluch-Bergada A. Basal joint arthroplasty and carpal tunnel release comparing a single versus double incision: a prospective randomized study. Eur J Orthop Surg Traumatol. 2022 Oct;32(7):1391-1397. doi: 10.1007/s00590-021-03086-x. Epub 2021 Sep 22.