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Distraction vs Interposition Arthroplasty for Basilar Thumb Osteoarthritis

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ClinicalTrials.gov Identifier: NCT04155853
Recruitment Status : Recruiting
First Posted : November 7, 2019
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Dimitrios Kitridis, Aristotle University Of Thessaloniki

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.


Condition or disease Intervention/treatment Phase
Thumb Osteoarthritis Procedure: Interposition Arthroplasty Procedure: Hematoma and Distraction Arthroplasty Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Distraction Versus Interposition Arthroplasty for Thumb Carpometacarpal Joint Osteoarthritis: A Randomized Controlled Trial
Actual Study Start Date : April 16, 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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.




Primary Outcome Measures :
  1. "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.

  2. "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.

  3. "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.

  4. "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.

  5. "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.

  6. "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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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


Other Outcome Measures:
  1. Rate of complications [ Time Frame: Up to two years postoperatively ]
    All complications will be documented and rates will be compared between the groups.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155853


Contacts
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Contact: Dimitrios Kitridis, MD +23133077686 dkitridis@gmail.com

Locations
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Greece
"George Papanikolaou" Hospital Recruiting
Thessaloniki, Exohi, Greece, 55210
Contact: Head of Orthopaedics Department    +302313307681    orthopaedikipapanikolaou@gmail.com   
Sub-Investigator: Dimitrios Kitridis, MD         
Principal Investigator: Panagiotis Givissis, Professor         
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
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Study Director: Panagiotis Givissis, Professor Aristotle University Of Thessaloniki
Publications:

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Responsible Party: Dimitrios Kitridis, Principal Investigator, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT04155853    
Other Study ID Numbers: 597/2019
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dimitrios Kitridis, Aristotle University Of Thessaloniki:
trapeziectomy
fascia lata
interposition
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases