search
Back to results

Concomitant Basal Joint Arthroplasty and Carpal Tunnel Release

Primary Purpose

Carpal Tunnel Syndrome, Osteoarthritis Thumb

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Carpal tunnel release and basal joint arthroplasty through single incision
Carpal tunnel release and basal joint arthroplasty through double incision
Sponsored by
Hospital Universitari Vall d'Hebron Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ignacio Esteban Feliu

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Single incision

Double incision

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
Change of hand pain
Pain was assessed through 10-visual analog scale. Minimum score is 0 (no pain) and maximum 10 (sever pain).
Change of grip strength
Grip strength was measured the mean of 3 attempts, in kilograms, with correction for hand dominance, using a standard dynamometer.

Full Information

First Posted
April 29, 2020
Last Updated
May 15, 2020
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT04391751
Brief Title
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

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome, Osteoarthritis Thumb

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single incision
Arm Type
Experimental
Arm Description
Carpal tunnel release and basal joint arthroplasty through a single radial approach
Arm Title
Double incision
Arm Type
Active Comparator
Arm Description
Double approach: carpal tunnel release through palmar approach and basal joint arthroplasty through radial approach
Intervention Type
Procedure
Intervention Name(s)
Carpal tunnel release and basal joint arthroplasty through single incision
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Carpal tunnel release and basal joint arthroplasty through double incision
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of CTS symptoms intensity
Description
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.
Time Frame
Preoperatively, 3, 6, and 12 months postoperatively
Secondary Outcome Measure Information:
Title
Change of hand function
Description
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).
Time Frame
Preoperatively, 3, 6, and 12 months postoperatively
Title
Change of hand pain
Description
Pain was assessed through 10-visual analog scale. Minimum score is 0 (no pain) and maximum 10 (sever pain).
Time Frame
Preoperatively, 3, 6, and 12 months postoperatively
Title
Change of grip strength
Description
Grip strength was measured the mean of 3 attempts, in kilograms, with correction for hand dominance, using a standard dynamometer.
Time Frame
Preoperatively, 3, 6, and 12 months postoperatively
Other Pre-specified Outcome Measures:
Title
Complications associated with the different surgical procedures
Description
Complications such as pillar pain, longer surgical procedure, infection rate or necrosis of the skin bridge between incisions
Time Frame
At 2 weeks posteoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Ignacio Esteban Feliu
City
Barcelona
ZIP/Postal Code
08035
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
3711604
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. doi: 10.1016/s0363-5023(86)80137-x.
Results Reference
background
PubMed Identifier
6491213
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. doi: 10.1016/s0363-5023(84)80015-5.
Results Reference
background
PubMed Identifier
29969109
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.
Results Reference
background
PubMed Identifier
8077824
Citation
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.
Results Reference
background
PubMed Identifier
15234492
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. doi: 10.1016/j.jhsb.2004.02.009.
Results Reference
background
PubMed Identifier
26330770
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.
Results Reference
background
PubMed Identifier
15576220
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. doi: 10.1016/j.jhsa.2004.07.003.
Results Reference
background
PubMed Identifier
26422193
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.
Results Reference
background
PubMed Identifier
34550476
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.
Results Reference
derived

Learn more about this trial

Concomitant Basal Joint Arthroplasty and Carpal Tunnel Release

We'll reach out to this number within 24 hrs