An interventional study of Interposition Arthroplasty and Hematoma and Distraction Arthroplasty in Thumb Osteoarthritis, sponsored by Aristotle University Of Thessaloniki. Status unknown at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-08.
Sponsored by Aristotle University Of Thessaloniki · Not applicable, Interventional, and Treatment
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.
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's planned enrollment of 22 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
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Exclusion Criteria:
Fascia lata interposition arthroplasty for the treatment of thumb carpometacarpal joint osteoarthritis
Procedure: Interposition Arthroplasty
Hematoma and Distraction Arthroplasty for the treatment of thumb carpometacarpal joint osteoarthritis
Procedure: 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 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.
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.
"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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: two years
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.
Time frame: six months
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.
Time frame: one year
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.
Time frame: two years
Kapandji score for thumb opposition
Comparison of the Kapandji score between the groups. Minimum 0, Maximum 10, higher scores mean a better outcome
Time frame: six months
Kapandji score for thumb opposition
Comparison of the Kapandji score between the groups. Minimum 0, Maximum 10, higher scores mean a better outcome
Time frame: one year
Kapandji score for thumb opposition
Comparison of the Kapandji score between the groups. Minimum 0, Maximum 10, higher scores mean a better outcome
Time frame: two years
Rate of complications
All complications will be documented and rates will be compared between the groups.
Time frame: Up to two years postoperatively
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Aristotle University Of Thessaloniki