Distraction vs Interposition Arthroplasty for Basilar Thumb Osteoarthritis

NCT04155853 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-03-08

No results posted yet for this study

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

Interventions

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.

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 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.

Sponsors & Collaborators

  • Aristotle University Of Thessaloniki

    lead OTHER

Principal Investigators

  • Panagiotis Givissis, Professor · Aristotle University Of Thessaloniki

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-16
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04155853 on ClinicalTrials.gov