Distraction vs Interposition Arthroplasty for Basilar Thumb Osteoarthritis

Thumb Osteoarthritis Clinical Trial

Official title:

Distraction Versus Interposition Arthroplasty for Thumb Carpometacarpal Joint Osteoarthritis: A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04155853
• Other study ID #: 597/2019
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 16, 2019
• Est. completion date: December 2022

Study information

• Verified date: March 2022
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Osteoarthritis is a degenerative disease of the joints, mostly known for the hip and the knee. Osteoarthritis of the thumb carpometacarpal joint is a common cause for pain, stiffness and grip weakness of the hand, affecting one of three females and one of eight males. Surgical management 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. A recent Cochrane review was unable to demonstrate whether any technique confers a benefit over distraction arthroplasty and noted that the quality of evidence was low.

Hematoma arthroplasty includes trapeziectomy without interposition of any material or ligament reconstruction. Later, the same technique with the addition of a temporary K-wire stabilization of the first metacarpal has been described it as hematoma and distraction arthroplasty. They immobilized the metacarpal in an overcorrected position to avoid postoperative weakness, assuming the causative factor was the subsidence of the metacarpal into the trapezial void, and they reported improved outcomes. 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. The technique showed promising results in a long-term follow-up study, and proved to be a viable alternative to distraction arthroplasty with no donor site morbidity and better preservation of the height of the metacarpal. However, there is no robust evidence that retaining the joint space affects the functional results or the grip strength of the patients.

Aim of the study 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, which is one option widely utilized. 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.

The study will be conducted in accordance with the Declaration of Helsinki and the Guidelines on Good Clinical Practice.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Previous operation to the affected area

• Pregnant patient

• Chronic systemic illnesses

Related Conditions & MeSH terms

• Osteoarthritis
• Thumb Osteoarthritis

Intervention

Procedure:
• Interposition Arthroplasty
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.
• Hematoma and Distraction Arthroplasty
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.

Locations

Country	Name	City	State
Greece	"George Papanikolaou" Hospital	Thessaloniki	Exohi

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

References & Publications (16)

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. — View Citation

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. — View Citation

Dupont WD, Plummer WD Jr. Power and sample size calculations. A review and computer program. Control Clin Trials. 1990 Apr;11(2):116-28. — View Citation

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. Review. — View Citation

Eaton RG, Littler JW. Ligament reconstruction for the painful thumb carpometacarpal joint. J Bone Joint Surg Am. 1973 Dec;55(8):1655-66. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Kapandji A. [Clinical test of apposition and counter-apposition of the thumb]. Ann Chir Main. 1986;5(1):67-73. French. — View Citation

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. — View Citation

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. Review. — View Citation

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

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. Review. — View Citation

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. — View Citation

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. — View Citation

Wajon A, Vinycomb T, Carr E, Edmunds I, Ada L. Surgery for thumb (trapeziometacarpal joint) osteoarthritis. Cochrane Database Syst Rev. 2015 Feb 23;(2):CD004631. doi: 10.1002/14651858.CD004631.pub4. Review. Update in: Cochrane Database Syst Rev. 2017 Apr 03;4:CD004631. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of complications	All complications will be documented and rates will be compared between the groups.	Up to two years postoperatively
Primary	"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
Primary	"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
Primary	"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
Primary	"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
Primary	"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
Primary	"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	Thumb range of motion (ROM)	Comparison of thumb ROM between the groups. Flexion, extension, and abduction will be measured for thumb carpometacarpal and interphalangeal joints using a goniometer.	six months
Secondary	Thumb range of motion (ROM)	Comparison of thumb ROM between the groups. Flexion, extension, and abduction will be measured for thumb carpometacarpal and interphalangeal joints using a goniometer.	one year
Secondary	Thumb range of motion (ROM)	Comparison of thumb ROM between the groups. Flexion, extension, and abduction will be measured for thumb carpometacarpal and interphalangeal joints using a goniometer.	two years
Secondary	Kapandji score for thumb opposition	Comparison of the Kapandji score between the groups. Minimum 0, Maximum 10, higher scores mean a better outcome	six months
Secondary	Kapandji score for thumb opposition	Comparison of the Kapandji score between the groups. Minimum 0, Maximum 10, higher scores mean a better outcome	one year
Secondary	Kapandji score for thumb opposition	Comparison of the Kapandji score between the groups. Minimum 0, Maximum 10, higher scores mean a better outcome	two years