Distraction vs Interposition Arthroplasty for Basilar Thumb Osteoarthritis

March 5, 2022 updated by: Dimitrios Kitridis, Aristotle University Of Thessaloniki

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Exohi
      • Thessaloniki, Exohi, Greece, 55210
        • "George Papanikolaou" Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Interposition Arthroplasty
Fascia lata interposition arthroplasty for the treatment of thumb carpometacarpal joint osteoarthritis
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.
Active Comparator: Hematoma and Distraction 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
"Quick Disabilities of the Arm, Shoulder, and Hand" (QuickDASH) functional score
Time Frame: six months
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
Time Frame: one year
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
Time Frame: two years
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
Time Frame: six months
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
Time Frame: one year
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
Time Frame: two years
Comparison of the VAS for pain between the groups. Minimum 0, Maximum 100, higher scores mean a worse outcome.
two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thumb range of motion (ROM)
Time Frame: six months
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
Thumb range of motion (ROM)
Time Frame: one year
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
Thumb range of motion (ROM)
Time Frame: two years
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
Kapandji score for thumb opposition
Time Frame: six months
Comparison of the Kapandji score between the groups. Minimum 0, Maximum 10, higher scores mean a better outcome
six months
Kapandji score for thumb opposition
Time Frame: one year
Comparison of the Kapandji score between the groups. Minimum 0, Maximum 10, higher scores mean a better outcome
one year
Kapandji score for thumb opposition
Time Frame: two years
Comparison of the Kapandji score between the groups. Minimum 0, Maximum 10, higher scores mean a better outcome
two years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of complications
Time Frame: Up to two years postoperatively
All complications will be documented and rates will be compared between the groups.
Up to two years postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Investigators

  • Study Director: Panagiotis Givissis, Professor, Aristotle University Of Thessaloniki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2019

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

November 4, 2019

First Submitted That Met QC Criteria

November 5, 2019

First Posted (Actual)

November 7, 2019

Study Record Updates

Last Update Posted (Actual)

March 8, 2022

Last Update Submitted That Met QC Criteria

March 5, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 597/2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Thumb Osteoarthritis

Clinical Trials on Interposition Arthroplasty

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe