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Distraction vs Interposition Arthroplasty for Basilar Thumb Osteoarthritis

Primary Purpose

Thumb Osteoarthritis

Status
Active
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Interposition Arthroplasty
Hematoma and Distraction Arthroplasty
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thumb Osteoarthritis focused on measuring trapeziectomy, fascia lata, interposition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • "George Papanikolaou" Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Interposition Arthroplasty

Hematoma and Distraction Arthroplasty

Arm Description

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

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

Outcomes

Primary Outcome Measures

"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.
"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.
"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.
"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.
"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.
"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.

Secondary Outcome Measures

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.
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.
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.
Kapandji score for thumb opposition
Comparison of the Kapandji score between the groups. Minimum 0, Maximum 10, higher scores mean a better outcome
Kapandji score for thumb opposition
Comparison of the Kapandji score between the groups. Minimum 0, Maximum 10, higher scores mean a better outcome
Kapandji score for thumb opposition
Comparison of the Kapandji score between the groups. Minimum 0, Maximum 10, higher scores mean a better outcome

Full Information

First Posted
November 4, 2019
Last Updated
March 5, 2022
Sponsor
Aristotle University Of Thessaloniki
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1. Study Identification

Unique Protocol Identification Number
NCT04155853
Brief Title
Distraction vs Interposition Arthroplasty for Basilar Thumb Osteoarthritis
Official Title
Distraction Versus Interposition Arthroplasty for Thumb Carpometacarpal Joint Osteoarthritis: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 16, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thumb Osteoarthritis
Keywords
trapeziectomy, fascia lata, interposition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interposition Arthroplasty
Arm Type
Active Comparator
Arm Description
Fascia lata interposition arthroplasty for the treatment of thumb carpometacarpal joint osteoarthritis
Arm Title
Hematoma and Distraction Arthroplasty
Arm Type
Active Comparator
Arm Description
Hematoma and Distraction Arthroplasty for the treatment of thumb carpometacarpal joint osteoarthritis
Intervention Type
Procedure
Intervention Name(s)
Interposition Arthroplasty
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Hematoma and Distraction Arthroplasty
Intervention Description
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.
Primary Outcome Measure Information:
Title
"Quick Disabilities of the Arm, Shoulder, and Hand" (QuickDASH) functional score
Description
Comparison of the Quick DASH score between the groups. Minimum 0, Maximum 100, higher scores mean a worse outcome.
Time Frame
six months
Title
"Quick Disabilities of the Arm, Shoulder, and Hand" (QuickDASH) functional score
Description
Comparison of the Quick DASH score between the groups. Minimum 0, Maximum 100, higher scores mean a worse outcome.
Time Frame
one year
Title
"Quick Disabilities of the Arm, Shoulder, and Hand" (QuickDASH) functional score
Description
Comparison of the Quick DASH score between the groups. Minimum 0, Maximum 100, higher scores mean a worse outcome.
Time Frame
two years
Title
"Visual Analog Scale" (VAS) for pain relief
Description
Comparison of the VAS for pain between the groups. Minimum 0, Maximum 100, higher scores mean a worse outcome.
Time Frame
six months
Title
"Visual Analog Scale" (VAS) for pain relief
Description
Comparison of the VAS for pain between the groups. Minimum 0, Maximum 100, higher scores mean a worse outcome.
Time Frame
one year
Title
"Visual Analog Scale" (VAS) for pain relief
Description
Comparison of the VAS for pain between the groups. Minimum 0, Maximum 100, higher scores mean a worse outcome.
Time Frame
two years
Secondary Outcome Measure Information:
Title
Thumb range of motion (ROM)
Description
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
Title
Thumb range of motion (ROM)
Description
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
Title
Thumb range of motion (ROM)
Description
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
Title
Kapandji score for thumb opposition
Description
Comparison of the Kapandji score between the groups. Minimum 0, Maximum 10, higher scores mean a better outcome
Time Frame
six months
Title
Kapandji score for thumb opposition
Description
Comparison of the Kapandji score between the groups. Minimum 0, Maximum 10, higher scores mean a better outcome
Time Frame
one year
Title
Kapandji score for thumb opposition
Description
Comparison of the Kapandji score between the groups. Minimum 0, Maximum 10, higher scores mean a better outcome
Time Frame
two years
Other Pre-specified Outcome Measures:
Title
Rate of complications
Description
All complications will be documented and rates will be compared between the groups.
Time Frame
Up to two years postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Panagiotis Givissis, Professor
Organizational Affiliation
Aristotle University Of Thessaloniki
Official's Role
Study Director
Facility Information:
Facility Name
"George Papanikolaou" Hospital
City
Thessaloniki
State/Province
Exohi
ZIP/Postal Code
55210
Country
Greece

12. IPD Sharing Statement

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Citation
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Distraction vs Interposition Arthroplasty for Basilar Thumb Osteoarthritis

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