Distraction vs Interposition Arthroplasty for Basilar Thumb Osteoarthritis

NCT04155853 | Unknown

• 1 other identifier: 597/2019
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Surgical management for osteoarthritis of the thumb is indicated when conservative measures have failed, and numerous techniques have been proposed. Distraction arthroplasty has been the gold standard due to lack of high quality evidence, which renders the benefits or harms of other techniques uncertain. The other treatment alternatives share at least partial excision of the trapezium, and include ligament reconstruction alone or with tendon interposition, allograft interposition arthroplasty, prosthetic implants and arthrodesis. A recent promising technique is the pillow technique, a type of interposition arthroplasty, which utilizes a fascia lata allograft as interposition material and stabilization with a K-wire. In view of the low quality evidence regarding the use of interposition material versus distraction arthroplasty alone, the investigators will compare the two methods in a prospective randomized study design. Hypothesis of the study is that interposition arthroplasty using the pillow technique yields better results in terms of functional improvement and grip strength when compared to the hematoma and distraction technique. The confirmation of the hypothesis is going to justify the use of the fascia lata in the procedure. On the contrary, if the pillow technique fails to yield clinically meaningful results, the recommendation of the hematoma and distraction technique will account for reducing the overall cost of the procedure, rendering the allograft redundant.

Conditions

Thumb Osteoarthritis

Keywords

trapeziectomy; fascia lata; interposition

Outcome Measures

Primary Outcomes (6)

• "Quick Disabilities of the Arm, Shoulder, and Hand" (QuickDASH) functional score

  Comparison of the Quick DASH score between the groups. Minimum 0, Maximum 100, higher scores mean a worse outcome.

  six months

• "Quick Disabilities of the Arm, Shoulder, and Hand" (QuickDASH) functional score

  Comparison of the Quick DASH score between the groups. Minimum 0, Maximum 100, higher scores mean a worse outcome.

  one year

• "Quick Disabilities of the Arm, Shoulder, and Hand" (QuickDASH) functional score

  Comparison of the Quick DASH score between the groups. Minimum 0, Maximum 100, higher scores mean a worse outcome.

  two years

• "Visual Analog Scale" (VAS) for pain relief

  Comparison of the VAS for pain between the groups. Minimum 0, Maximum 100, higher scores mean a worse outcome.

  six months

• "Visual Analog Scale" (VAS) for pain relief

  Comparison of the VAS for pain between the groups. Minimum 0, Maximum 100, higher scores mean a worse outcome.

  one year

• "Visual Analog Scale" (VAS) for pain relief

  Comparison of the VAS for pain between the groups. Minimum 0, Maximum 100, higher scores mean a worse outcome.

  two years

Secondary Outcomes (6)

• Thumb range of motion (ROM)

  six months

• Thumb range of motion (ROM)

  one year

• Thumb range of motion (ROM)

  two years

• Kapandji score for thumb opposition

  six months

• Kapandji score for thumb opposition

  one year

Other Outcomes (1)

• Rate of complications

  Up to two years postoperatively

Study Arms (2)

Interposition Arthroplasty

ACTIVE COMPARATOR

Fascia lata interposition arthroplasty for the treatment of thumb carpometacarpal joint osteoarthritis

Procedure: Interposition Arthroplasty

Hematoma and Distraction Arthroplasty

ACTIVE COMPARATOR

Hematoma and Distraction Arthroplasty for the treatment of thumb carpometacarpal joint osteoarthritis

Procedure: Hematoma and Distraction Arthroplasty

Interventions

Interposition Arthroplasty PROCEDURE

A typical Wagner incision will be used at the thenar skin one centimeter distal to the radial styloid. The interval between the abductor pollicis longus and the extensor pollicis brevis will be developed, while protecting the dorsal sensory branches of the radial nerve. A longitudinal capsulotomy will be performed and after identifying the carpometacarpal and scaphotrapeziotrapezoid joints, the trapezium will be excised. Then, the empty space will be filled with a roll of fascia lata and fixed with a K-wire. The 1.4 millimeter K-wire will be introduced two centimeters distally to the metacarpal base and into the body of the trapezium. In case of scaphotrapeziotrapezoid joint arthritis, debridement and osteophyte excision of the scaphotrapezoid joint will be performed. In the end of the procedure, the capsule and the skin will be sutured, and a thumb spica will be placed to all patients.

Interposition Arthroplasty

Hematoma and Distraction Arthroplasty PROCEDURE

A typical Wagner incision will be used at the thenar skin one centimeter distal to the radial styloid. The interval between the abductor pollicis longus and the extensor pollicis brevis will be developed, while protecting the dorsal sensory branches of the radial nerve. A longitudinal capsulotomy will be performed and after identifying the carpometacarpal and scaphotrapeziotrapezoid joints, the trapezium will be excised. Then, the empty space will be stabilized with a K-wire without interposition of any material. The 1.4 millimeter K-wire will be introduced two centimeters distally to the metacarpal base and into the body of the trapezium. In case of scaphotrapeziotrapezoid joint arthritis, debridement and osteophyte excision of the scaphotrapezoid joint will be performed. In the end of the procedure, the capsule and the skin will be sutured, and a thumb spica will be placed to all patients.

Hematoma and Distraction Arthroplasty

Eligibility Criteria

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

You may qualify if:

• Thumb carpometacarpal osteoarthritis Stage III and IV according to the Eaton and Littler classification
• At least one month history of pain refractory to nonoperative treatment (rest, non-steroidal anti-inflammatory medicine, splint, hand therapy, a maximum of three corticosteroid injections)
• Patient willing to participate to the study

You may not qualify if:

• Previous operation to the affected area
• Pregnant patient
• Chronic systemic illnesses

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

"George Papanikolaou" Hospital

Thessaloniki, Exohi, 55210, Greece

Location

Related Publications (16)

• Sodha S, Ring D, Zurakowski D, Jupiter JB. Prevalence of osteoarthrosis of the trapeziometacarpal joint. J Bone Joint Surg Am. 2005 Dec;87(12):2614-2618. doi: 10.2106/JBJS.E.00104.

  PMID: 16322609 BACKGROUND

• Martou G, Veltri K, Thoma A. Surgical treatment of osteoarthritis of the carpometacarpal joint of the thumb: a systematic review. Plast Reconstr Surg. 2004 Aug;114(2):421-32. doi: 10.1097/01.prs.0000131989.86319.b1.

  PMID: 15277809 BACKGROUND

• Wajon A, Vinycomb T, Carr E, Edmunds I, Ada L. Surgery for thumb (trapeziometacarpal joint) osteoarthritis. Cochrane Database Syst Rev. 2015 Feb 23;2015(2):CD004631. doi: 10.1002/14651858.CD004631.pub4.

  PMID: 25702783 BACKGROUND

• Gervis WH, Wells T. A review of excision of the trapezium for osteoarthritis of the trapezio-metacarpal joint after twenty-five years. J Bone Joint Surg Br. 1973 Feb;55(1):56-7. No abstract available.

  PMID: 4693892 BACKGROUND

• Kuhns CA, Emerson ET, Meals RA. Hematoma and distraction arthroplasty for thumb basal joint osteoarthritis: a prospective, single-surgeon study including outcomes measures. J Hand Surg Am. 2003 May;28(3):381-9. doi: 10.1053/jhsu.2003.50078.

  PMID: 12772092 BACKGROUND

• Givissis P, Sachinis NP, Akritopoulos P, Stavridis SI, Christodoulou A. The "Pillow" Technique for Thumb Carpometacarpal Joint Arthritis: Cohort Study With 10- to 15-Year Follow-Up. J Hand Surg Am. 2016 Jul;41(7):775-81. doi: 10.1016/j.jhsa.2016.04.018. Epub 2016 May 21.

  PMID: 27215594 BACKGROUND

• Heller GZ, Manuguerra M, Chow R. How to analyze the Visual Analogue Scale: Myths, truths and clinical relevance. Scand J Pain. 2016 Oct;13:67-75. doi: 10.1016/j.sjpain.2016.06.012. Epub 2016 Jul 27.

  PMID: 28850536 BACKGROUND

• Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. doi: 10.1016/j.pain.2004.09.012. No abstract available.

  PMID: 15621359 BACKGROUND

• Smith MV, Calfee RP, Baumgarten KM, Brophy RH, Wright RW. Upper extremity-specific measures of disability and outcomes in orthopaedic surgery. J Bone Joint Surg Am. 2012 Feb 1;94(3):277-85. doi: 10.2106/JBJS.J.01744.

  PMID: 22298061 BACKGROUND

• Calfee RP, Adams AA. Clinical research and patient-rated outcome measures in hand surgery. J Hand Surg Am. 2012 Apr;37(4):851-5. doi: 10.1016/j.jhsa.2012.01.043.

  PMID: 22464236 BACKGROUND

• Kapandji A. [Clinical test of apposition and counter-apposition of the thumb]. Ann Chir Main. 1986;5(1):67-73. doi: 10.1016/s0753-9053(86)80053-9. French.

  PMID: 3963909 BACKGROUND

• Eaton RG, Littler JW. Ligament reconstruction for the painful thumb carpometacarpal joint. J Bone Joint Surg Am. 1973 Dec;55(8):1655-66. No abstract available.

  PMID: 4804988 BACKGROUND

• Vermeulen GM, Brink SM, Slijper H, Feitz R, Moojen TM, Hovius SE, Selles RW. Trapeziometacarpal arthrodesis or trapeziectomy with ligament reconstruction in primary trapeziometacarpal osteoarthritis: a randomized controlled trial. J Bone Joint Surg Am. 2014 May 7;96(9):726-33. doi: 10.2106/JBJS.L.01344.

  PMID: 24806009 BACKGROUND

• Barthel L, Hidalgo Diaz JJ, Vernet P, Gouzou S, Facca S, Igeta Y, Liverneaux P. Results of the treatment of first carpometacarpal joint osteoarthritis: trapeziectomy alone versus trapeziectomy associated with suspensionplasty. Eur J Orthop Surg Traumatol. 2018 Dec;28(8):1555-1561. doi: 10.1007/s00590-018-2173-3. Epub 2018 Mar 7.

  PMID: 29516197 BACKGROUND

• Dupont WD, Plummer WD Jr. Power and sample size calculations. A review and computer program. Control Clin Trials. 1990 Apr;11(2):116-28. doi: 10.1016/0197-2456(90)90005-m.

  PMID: 2161310 BACKGROUND

• Nicholson RH, Crawley FP. Revising the Declaration of Helsinki: a fresh start. Bull Med Ethics. 1999 Oct;No. 151:13-7. No abstract available.

  PMID: 11657985 BACKGROUND

Study Officials

• Panagiotis Givissis, Professor

  Aristotle University Of Thessaloniki

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 7, 2019
• Study Start: April 16, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 8, 2022

Record last verified: 2022-03

Locations

GR (1)