Concomitant Basal Joint Arthroplasty and Carpal Tunnel Release
- Conditions
- Carpal Tunnel SyndromeOsteoarthritis Thumb
- Interventions
- Procedure: Carpal tunnel release and basal joint arthroplasty through single incisionProcedure: Carpal tunnel release and basal joint arthroplasty through double incision
- Registration Number
- NCT04391751
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- 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.
- Pregnancy
- Diabetes mellitus
- Acute trauma
- Rheumatoid arthritis
- Hipothyroidism
- Hyperthiroidism
- Posttraumatic arthritis
- Prior hand surgery procedures
- Nerve compression at proximal level
- Other nerve entrapments
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Single incision Carpal tunnel release and basal joint arthroplasty through single incision Carpal tunnel release and basal joint arthroplasty through a single radial approach Double incision Carpal tunnel release and basal joint arthroplasty through double incision Double approach: carpal tunnel release through palmar approach and basal joint arthroplasty through radial approach
- Primary Outcome Measures
Name Time Method Change of CTS symptoms intensity Preoperatively, 3, 6, and 12 months postoperatively 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.
- Secondary Outcome Measures
Name Time Method Change of hand function Preoperatively, 3, 6, and 12 months postoperatively 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).
Change of hand pain Preoperatively, 3, 6, and 12 months postoperatively Pain was assessed through 10-visual analog scale. Minimum score is 0 (no pain) and maximum 10 (sever pain).
Change of grip strength Preoperatively, 3, 6, and 12 months postoperatively Grip strength was measured the mean of 3 attempts, in kilograms, with correction for hand dominance, using a standard dynamometer.
Trial Locations
- Locations (1)
Ignacio Esteban Feliu
🇪🇸Barcelona, Spain