Thumb OsteoarthritisNCT04155853
Distraction vs Interposition Arthroplasty for Basilar Thumb Osteoarthritis
A study testing Interposition Arthroplasty and Hematoma and Distraction Arthroplasty in people with Thumb Osteoarthritis, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thumb Osteoarthritis
- What is being tested?
- Interposition Arthroplasty and Hematoma and Distraction Arthroplasty
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteGreece
- Study dates
- 16 Apr 2019to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous operation to the affected area
- Pregnant patient
- Chronic systemic illnesses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Thumb Osteoarthritis
- Being tested
- Interposition Arthroplasty, Hematoma and Distraction Arthroplasty
- Keywords
- trapeziectomy, fascia lata, interposition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interposition ArthroplastyProcedure or surgery
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.
Hematoma and Distraction ArthroplastyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Interposition Arthroplasty | Active comparator | Fascia lata interposition arthroplasty for the treatment of thumb carpometacarpal joint osteoarthritis Receives: Procedure: Interposition Arthroplasty |
| Hematoma and Distraction Arthroplasty | Active comparator | Hematoma and Distraction Arthroplasty for the treatment of thumb carpometacarpal joint osteoarthritis Receives: Procedure: Hematoma and Distraction Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
"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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: two years
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start16 Apr 2019
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Thumb OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitrios Kitridis, Aristotle University Of Thessaloniki
- Investigators
- Panagiotis Givissis, Professor, Study director, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155853
- Sponsor's protocol ID
- 597/2019
- Status last verified
- Mar 2022
- First submitted
- 4 Nov 2019
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sodha S, Ring D, Zurakowski D, Jupiter JB. Prevalence of osteoarthrosis of the trapeziometacarpal joint. J Bone Joint Surg Am. 2005 Dec;87(12):2614-2618. doi: 10.2106/JBJS.E.00104.
PubMed 16322609Martou G, Veltri K, Thoma A. Surgical treatment of osteoarthritis of the carpometacarpal joint of the thumb: a systematic review. Plast Reconstr Surg. 2004 Aug;114(2):421-32. doi: 10.1097/01.prs.0000131989.86319.b1.
PubMed 15277809Wajon A, Vinycomb T, Carr E, Edmunds I, Ada L. Surgery for thumb (trapeziometacarpal joint) osteoarthritis. Cochrane Database Syst Rev. 2015 Feb 23;2015(2):CD004631. doi: 10.1002/14651858.CD004631.pub4.
PubMed 25702783Gervis WH, Wells T. A review of excision of the trapezium for osteoarthritis of the trapezio-metacarpal joint after twenty-five years. J Bone Joint Surg Br. 1973 Feb;55(1):56-7. No abstract available.
PubMed 4693892Kuhns CA, Emerson ET, Meals RA. Hematoma and distraction arthroplasty for thumb basal joint osteoarthritis: a prospective, single-surgeon study including outcomes measures. J Hand Surg Am. 2003 May;28(3):381-9. doi: 10.1053/jhsu.2003.50078.
PubMed 12772092Givissis P, Sachinis NP, Akritopoulos P, Stavridis SI, Christodoulou A. The "Pillow" Technique for Thumb Carpometacarpal Joint Arthritis: Cohort Study With 10- to 15-Year Follow-Up. J Hand Surg Am. 2016 Jul;41(7):775-81. doi: 10.1016/j.jhsa.2016.04.018. Epub 2016 May 21.
PubMed 27215594Heller GZ, Manuguerra M, Chow R. How to analyze the Visual Analogue Scale: Myths, truths and clinical relevance. Scand J Pain. 2016 Oct;13:67-75. doi: 10.1016/j.sjpain.2016.06.012. Epub 2016 Jul 27.
PubMed 28850536Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. doi: 10.1016/j.pain.2004.09.012. No abstract available.
PubMed 15621359Smith MV, Calfee RP, Baumgarten KM, Brophy RH, Wright RW. Upper extremity-specific measures of disability and outcomes in orthopaedic surgery. J Bone Joint Surg Am. 2012 Feb 1;94(3):277-85. doi: 10.2106/JBJS.J.01744.
PubMed 22298061Calfee RP, Adams AA. Clinical research and patient-rated outcome measures in hand surgery. J Hand Surg Am. 2012 Apr;37(4):851-5. doi: 10.1016/j.jhsa.2012.01.043.
PubMed 22464236Kapandji A. [Clinical test of apposition and counter-apposition of the thumb]. Ann Chir Main. 1986;5(1):67-73. doi: 10.1016/s0753-9053(86)80053-9. French.
PubMed 3963909Eaton RG, Littler JW. Ligament reconstruction for the painful thumb carpometacarpal joint. J Bone Joint Surg Am. 1973 Dec;55(8):1655-66. No abstract available.
PubMed 4804988Vermeulen GM, Brink SM, Slijper H, Feitz R, Moojen TM, Hovius SE, Selles RW. Trapeziometacarpal arthrodesis or trapeziectomy with ligament reconstruction in primary trapeziometacarpal osteoarthritis: a randomized controlled trial. J Bone Joint Surg Am. 2014 May 7;96(9):726-33. doi: 10.2106/JBJS.L.01344.
PubMed 24806009Barthel L, Hidalgo Diaz JJ, Vernet P, Gouzou S, Facca S, Igeta Y, Liverneaux P. Results of the treatment of first carpometacarpal joint osteoarthritis: trapeziectomy alone versus trapeziectomy associated with suspensionplasty. Eur J Orthop Surg Traumatol. 2018 Dec;28(8):1555-1561. doi: 10.1007/s00590-018-2173-3. Epub 2018 Mar 7.
PubMed 29516197Dupont WD, Plummer WD Jr. Power and sample size calculations. A review and computer program. Control Clin Trials. 1990 Apr;11(2):116-28. doi: 10.1016/0197-2456(90)90005-m.
PubMed 2161310
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distraction Versus Interposition Arthroplasty for Thumb Carpometacarpal Joint Osteoarthritis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04155853
- Acronym / sponsor ID
- 597/2019
- Conditions
- Thumb Osteoarthritis
- Keywords
- trapeziectomy, fascia lata, interposition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 7 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interposition Arthroplasty | Active comparator | Procedure: Interposition ArthroplastyFascia lata interposition arthroplasty for the treatment of thumb carpometacarpal joint osteoarthritis |
| Hematoma and Distraction Arthroplasty | Active comparator | Procedure: Hematoma and Distraction ArthroplastyHematoma and Distraction Arthroplasty for the treatment of thumb carpometacarpal joint osteoarthritis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Previous operation to the affected area
- Pregnant patient
- Chronic systemic illnesses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interposition ArthroplastyA 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 or surgery | Interposition Arthroplasty |
| Hematoma and Distraction ArthroplastyA 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. | Procedure or surgery | Hematoma and Distraction Arthroplasty |
Primary outcome
"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.
"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.
"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.
"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.
"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.
"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.
6 secondary outcomes
Thumb range of motion (ROM)
Time frame: six months
Thumb range of motion (ROM)
Time frame: one year
Thumb range of motion (ROM)
Time frame: two years
Kapandji score for thumb opposition
Time frame: six months
Kapandji score for thumb opposition
Time frame: one year
Kapandji score for thumb opposition
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Background: PubMed 16322609Sodha S, Ring D, Zurakowski D, Jupiter JB. Prevalence of osteoarthrosis of the trapeziometacarpal joint. J Bone Joint Surg Am. 2005 Dec;87(12):2614-2618. doi: 10.2106/JBJS.E.00104.
- Background: PubMed 15277809Martou G, Veltri K, Thoma A. Surgical treatment of osteoarthritis of the carpometacarpal joint of the thumb: a systematic review. Plast Reconstr Surg. 2004 Aug;114(2):421-32. doi: 10.1097/01.prs.0000131989.86319.b1.
- Background: PubMed 25702783Wajon A, Vinycomb T, Carr E, Edmunds I, Ada L. Surgery for thumb (trapeziometacarpal joint) osteoarthritis. Cochrane Database Syst Rev. 2015 Feb 23;2015(2):CD004631. doi: 10.1002/14651858.CD004631.pub4.
- Background: PubMed 4693892Gervis WH, Wells T. A review of excision of the trapezium for osteoarthritis of the trapezio-metacarpal joint after twenty-five years. J Bone Joint Surg Br. 1973 Feb;55(1):56-7. No abstract available.
- Background: PubMed 12772092Kuhns CA, Emerson ET, Meals RA. Hematoma and distraction arthroplasty for thumb basal joint osteoarthritis: a prospective, single-surgeon study including outcomes measures. J Hand Surg Am. 2003 May;28(3):381-9. doi: 10.1053/jhsu.2003.50078.
- Background: PubMed 27215594Givissis P, Sachinis NP, Akritopoulos P, Stavridis SI, Christodoulou A. The "Pillow" Technique for Thumb Carpometacarpal Joint Arthritis: Cohort Study With 10- to 15-Year Follow-Up. J Hand Surg Am. 2016 Jul;41(7):775-81. doi: 10.1016/j.jhsa.2016.04.018. Epub 2016 May 21.
- Background: PubMed 28850536Heller GZ, Manuguerra M, Chow R. How to analyze the Visual Analogue Scale: Myths, truths and clinical relevance. Scand J Pain. 2016 Oct;13:67-75. doi: 10.1016/j.sjpain.2016.06.012. Epub 2016 Jul 27.
- Background: PubMed 15621359Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. doi: 10.1016/j.pain.2004.09.012. No abstract available.
- Background: PubMed 22298061Smith MV, Calfee RP, Baumgarten KM, Brophy RH, Wright RW. Upper extremity-specific measures of disability and outcomes in orthopaedic surgery. J Bone Joint Surg Am. 2012 Feb 1;94(3):277-85. doi: 10.2106/JBJS.J.01744.
- Background: PubMed 22464236Calfee RP, Adams AA. Clinical research and patient-rated outcome measures in hand surgery. J Hand Surg Am. 2012 Apr;37(4):851-5. doi: 10.1016/j.jhsa.2012.01.043.
- Background: PubMed 3963909Kapandji A. [Clinical test of apposition and counter-apposition of the thumb]. Ann Chir Main. 1986;5(1):67-73. doi: 10.1016/s0753-9053(86)80053-9. French.
- Background: PubMed 4804988Eaton RG, Littler JW. Ligament reconstruction for the painful thumb carpometacarpal joint. J Bone Joint Surg Am. 1973 Dec;55(8):1655-66. No abstract available.
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Thumb Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Panagiotis Givissis, Professor study director
Aristotle University Of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interposition Arthroplasty and Hematoma and Distraction Arthroplasty in people with Thumb Osteoarthritis, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Quick Disabilities of the Arm, Shoulder, and Hand" (QuickDASH) functional score (time frame: six months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04155853, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2022.