Concomitant Basal Joint Arthroplasty and Carpal Tunnel Release

NCT04391751 | Unknown

• 1 other identifier: PR(ATR)147/2018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome; Osteoarthritis Thumb

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change of hand function

  Preoperatively, 3, 6, and 12 months postoperatively

• Change of hand pain

  Preoperatively, 3, 6, and 12 months postoperatively

• Change of grip strength

  Preoperatively, 3, 6, and 12 months postoperatively

Other Outcomes (1)

• Complications associated with the different surgical procedures

  At 2 weeks posteoperatively

Study Arms (2)

Single incision

EXPERIMENTAL

Carpal tunnel release and basal joint arthroplasty through a single radial approach

Procedure: Carpal tunnel release and basal joint arthroplasty through single incision

Double incision

ACTIVE COMPARATOR

Double approach: carpal tunnel release through palmar approach and basal joint arthroplasty through radial approach

Procedure: Carpal tunnel release and basal joint arthroplasty through double incision

Interventions

Carpal tunnel release and basal joint arthroplasty through single incision PROCEDURE

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.

Single incision

Carpal tunnel release and basal joint arthroplasty through double incision PROCEDURE

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.

Double incision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy
• Diabetes mellitus
• Acute trauma
• Rheumatoid arthritis
• Hipothyroidism
• Hyperthiroidism
• Posttraumatic arthritis
• Prior hand surgery procedures
• Nerve compression at proximal level
• Other nerve entrapments

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Ignacio Esteban Feliu

Barcelona, 08035, Spain

Location

Related Publications (9)

• 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. doi: 10.1016/s0363-5023(86)80137-x.

  PMID: 3711604 BACKGROUND

• 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. doi: 10.1016/s0363-5023(84)80015-5.

  PMID: 6491213 BACKGROUND

• 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.

  PMID: 29969109 BACKGROUND

• 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. doi: 10.1016/0266-7681(94)90085-x.

  PMID: 8077824 BACKGROUND

• 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. doi: 10.1016/j.jhsb.2004.02.009.

  PMID: 15234492 BACKGROUND

• 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.

  PMID: 26330770 BACKGROUND

• 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. doi: 10.1016/j.jhsa.2004.07.003.

  PMID: 15576220 BACKGROUND

• 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.

  PMID: 26422193 BACKGROUND

• 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.

  PMID: 34550476 DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 18, 2020
• Study Start: January 1, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: May 18, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)