Carpometacarpal OsteoarthritisNCT04588961
Trapeziectomy Suspensionplasty Versus Carpometacarpal Joint Replacement in Treatment of Basal Thumb Osteoarthritis
A study testing Trapeziectomy with suspensionplasty and Joint alloplasty in people with Carpometacarpal Osteoarthritis and Rhizarthrosis, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
This study compares and evaluates differences in movement analysis, patient-reported outcome, radiological assesment and muscular function between patients undergoing carpometacarpal joint arthroplasty with use of modern implants and trapeziectomy with suspensionplasty Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpometacarpal Osteoarthritis, Rhizarthrosis, Thumb Osteoarthritis
- What is being tested?
- Trapeziectomy with suspensionplasty and Joint alloplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2021to 31 Dec 2024
- 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
- osteoarthritis of carpometacarpal joint III or III/IV in Eaton classification assessed by two different radiologists
- symptoms that do not respond to non-operative treatment for 8 weeks
- no counterindications for anaesthesia
- signed agreement for taking a part into trial
Who cannot join
- patient do not agree to take a part into study
- problems with communication with patient
- unstable cardiac disease
- reoperations
- previous surgical interventions in hand
- neuro-muscular diseases
- rheumatological background of disease
- diagnosed cervical spine disorders
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Othopedics and Rehabilitation, Medical University of Warsaw
Warsaw, Masovian Voivodeship, 03-984
About this study
Official title: Comparison of Trapeziectomy With Suspensionplasty and Carpometacarpal Joint Replacement in Treatment of Basal Thumb Osteoarthritis: Randomised Clinical Trial
This study compares and evaluates differences in movement analysis, patient-reported outcome, radiological assesment and muscular function between patients undergoing carpometacarpal joint arthroplasty with use of modern implants and trapeziectomy with suspensionplasty
Read the detailed description
Osteoarthritis of first carpometacarpal joint is the most common degenerative disease of upper limb. According to data available in literature, it affects about 30% of women and 6% of men at the age of 45. Increasing with age, it rises up to 90% in people by the age of 80. Due to more widely spread electronic devices in offices, at work, at home which requires usage of thumb, increase in numbers mentioned above is strongly probable. The main symptoms are: pain, loose of grip strength and loose of function. The latter is most important fact, since about 50% of hand function is possible only with healthy thumb.
In many cases osteoarthritis can be treated by combined NSAIDs and splinting with rehabilitation. Sometimes when symptoms do not respond to non-operative treatment, there is a need for surgery. Trapeziectomy is the most common choice for operative treatment for end-stage basal thumb osteoarthritis. However, many other techniques were developed, there is continuous dispute over selecting the optimal . One of the most promising is arthroplasty using prosthesis. Last years many important advances were made in a design of implant and materials. Moreover the investigators now have many longer outcomes of such operation made in the past. All this data make us think more about using this technique often, since there are papers which show superiority over classical trapeziectomy. Even though there are several studies comparing functional and objective outcome of those techniques, there is a lack of evidence in terms of biomechanical analysis, thenar muscle activity and changes in movement patterns. Moreover there is no study published so far which considers modern implants and trapeziectomy with suspensionplasty. The aim of the study is to examine relationships between movement analysis (kinematic and functional outcomes), patient reported outcome measures (PROMS) and X-ray measurement, electromyography both pre- and post-operatively.
- Being tested
- Trapeziectomy with suspensionplasty, Joint alloplasty
- Keywords
- Thumb, Osteoarthritis, Trapeziectomy, Alloplasty, Biomechanics
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trapeziectomy with suspensionplastyProcedure or surgery
Surgical removal of trapezium bone and ligamentoplasty of first metacarpal bone using abductor pollicis tendon
Joint alloplastyProcedure or surgery
Also called Joint replacement
Surgical removal of degenerated joint surfaces nad replacement using modern designed prothesis
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Patients undergoing trapeziectomy with suspensionplasty for primary basal thumb osteoarthritis Receives: Procedure: Trapeziectomy with suspensionplasty |
| Study group | Active comparator | Patients undergoing joint alloplasty using prothesis for primary basal thumb osteoarthritis Receives: Procedure: Joint alloplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in patients reported outcomes - DASH (Disabilities of Arm, Shoulder and Hand)
To measure overall disabilities of upper limb. Results range from 0 to 100, with lower scores corresponding to better outcomes.
Measured: at baseline, 6 weeks and 6 months postoperatively
Secondary outcomes (12)
Changes in patients reported outcomes - PRWE (Patient Related Wrist Evaluation)
To measure wrist pain and disability in activities of daily living. Results range from 0 to 50, with lower scores corresponding to better outcomes.
Measured: at baseline, 6 weeks and 6 months postoperatively
Changes in patients reported outcomes - Michigan Hand Outcomes Questionaire
To explore differences in higher levels of activity at work and social participation. Results range from 0 to 100, with higher scores corresponding to better outcomes.
Measured: at baseline, 6 weeks and 6 months postoperatively
Changes in patients reported outcomes - SF-36 (Short Form 36)
To explore differences in quality of life. Results range from 0 to 100, with higher scores corresponding to better outcomes.
Measured: at baseline, 6 weeks and 6 months postoperatively
Changes in patients reported outcome measures - VAS (Visual Analogue Score)
To explore differences in pain. Results range from 0 to 100, with lower scores corresponding to better outcomes.
Measured: at baseline, 6 weeks and 6 months postoperatively
Changes in carpometacarpal, carpophalangeal and wrist range of motion
To explore differences in range of motion. This parameter will be measured with goniometer in flexion, extension, adduction and abduction in all thumb joints. Outcomes would be numers of degrees ranging from 0-360, with higher number corresponding with better outcomes
Measured: at baseline, 6 weeks and 6 months postoperatively
Changes in usage of painkillers
To asses evolution of post-operative thumb pain. Dosage, frequency of utilisation and type of medicines will be measured in self-designed questionnaire, with lower dosage, lower frequency and less powerful medicines corresponding with better results
Measured: at baseline, 6 weeks and 6 months postoperatively
Operation related complications
To count and asses all complications that may occur during surgery and in postoperative period
Measured: at baseline, 6 weeks and 6 months postoperatively
Arthroplasty revision surgeries
To count and asses the reason of all revision surgeries that may occur during postoperative period
Measured: at baseline, 6 weeks and 6 months postoperatively
Biomechanical 3D motion analysis
Movements in whole range are measured using 3D motion analysis, using a special software. With more physiological movement patterns corresponding with better results
Measured: at baseline, 6 weeks and 6 months postoperatively
Radiological outcome on x-rays
To asses any changes in alignment of implants with would be measured with degrees (angles) with more degrees of change after operation corresponding with worse outcome
Measured: at baseline, 6 weeks and 6 months postoperatively
Muscle strength outcomes
Muscle strength during grip measured using maximal voluntary isometric contraction (MVIC)
Measured: at baseline, 6 weeks and 6 months postoperatively
EMG measured bioelectrical potentials
Percutaneus electromyography (EMG) will be performed to measure bioelectrical potentials of thumb muscles, to assess ability to contracture
Measured: at baseline, 6 weeks and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Jun 2021 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Carpometacarpal OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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
- Model description
- Patients would be assigned randomly to 2 different groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Piotr Stępiński, MD, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588961
- Sponsor's protocol ID
- WarsawMU/thumb
- Status last verified
- Sep 2020
- First submitted
- 25 Sep 2020
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is still undecided because number of researchers included in the study is unknown
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 16322609Deiler S. [Basal joint osteoarthritis of the thumb]. Orthopade. 2019 Apr;48(4):351-366. doi: 10.1007/s00132-019-03707-8. German.
PubMed 30843103Weiss AC, Goodman AD. Thumb Basal Joint Arthritis. J Am Acad Orthop Surg. 2018 Aug 15;26(16):562-571. doi: 10.5435/JAAOS-D-17-00374.
PubMed 29969109Wajon 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 25702783Mahoney JD, Meals RA. Trapeziectomy. Hand Clin. 2006 May;22(2):165-9. doi: 10.1016/j.hcl.2006.02.003.
PubMed 16701128Naram A, Lyons K, Rothkopf DM, Calkins ER, Breen T, Jones M, Shufflebarger JV. Increased Complications in Trapeziectomy With Ligament Reconstruction and Tendon Interposition Compared With Trapeziectomy Alone. Hand (N Y). 2016 Mar;11(1):78-82. doi: 10.1177/1558944715617215. Epub 2016 Jan 14.
PubMed 27418894Sivakumar BS, Graham DJ. APL Lasso Suspensionplasty for Trapeziectomy. Tech Hand Up Extrem Surg. 2020 Sep;24(3):108-113. doi: 10.1097/BTH.0000000000000276.
PubMed 31876776Wang T, Zhao G, Rui YJ, Mi JY. Outcomes of modified trapeziectomy with ligament reconstruction tendon interposition for the treatment of advanced thumb carpometacarpal arthritis: Two-year follow-up. Medicine (Baltimore). 2018 Mar;97(13):e0235. doi: 10.1097/MD.0000000000010235.
PubMed 29595674Robles-Molina MJ, Lopez-Caba F, Gomez-Sanchez RC, Cardenas-Grande E, Pajares-Lopez M, Hernandez-Cortes P. Trapeziectomy With Ligament Reconstruction and Tendon Interposition Versus a Trapeziometacarpal Prosthesis for the Treatment of Thumb Basal Joint Osteoarthritis. Orthopedics. 2017 Jul 1;40(4):e681-e686. doi: 10.3928/01477447-20170503-03. Epub 2017 May 8.
PubMed 28481387Degeorge B, Dagneaux L, Andrin J, Lazerges C, Coulet B, Chammas M. Do trapeziometacarpal prosthesis provide better metacarpophalangeal stability than trapeziectomy and ligamentoplasty? Orthop Traumatol Surg Res. 2018 Nov;104(7):1095-1100. doi: 10.1016/j.otsr.2018.07.008. Epub 2018 Aug 11.
PubMed 30107277Lane JCE, Rodrigues JN, Furniss D, Burn E, Poulter R, Gardiner MD. Basal thumb osteoarthritis surgery improves health state utility irrespective of technique: a study of UK Hand Registry data. J Hand Surg Eur Vol. 2020 Jun;45(5):436-442. doi: 10.1177/1753193420909753. Epub 2020 Mar 12.
PubMed 32162998Parker S, Riley N, Dean B; Oxford Upper Limb Collaborative. Management of osteoarthritis at the base of the thumb. Bone Joint J. 2020 May;102-B(5):600-605. doi: 10.1302/0301-620X.102B5.BJJ-2019-1464.R2.
PubMed 32349588Al-Qattan MM, Al Mohrij SA. Mid-Term Results of Partial Trapeziectomy and Simple FCR Tendon Graft Interposition in a Selected Group of Patients with Thumb Carpometacarpal Joint Arthritis. J Hand Microsurg. 2020 Apr;12(1):43-46. doi: 10.1055/s-0039-1698356. Epub 2019 Nov 22.
PubMed 32280181Shah DS, Middleton C, Gurdezi S, Horwitz MD, Kedgley AE. The Effect of Surgical Treatments for Trapeziometacarpal Osteoarthritis on Wrist Biomechanics: A Cadaver Study. J Hand Surg Am. 2020 May;45(5):389-398. doi: 10.1016/j.jhsa.2019.10.003. Epub 2019 Nov 14.
PubMed 31733980Chug M, Williams N, Benn D, Brindley S. Outcome of uncemented trapeziometacarpal prosthesis for treatment of thumb carpometacarpal joint arthritis. Indian J Orthop. 2014 Jul;48(4):394-8. doi: 10.4103/0019-5413.136270.
PubMed 25143644
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Trapeziectomy With Suspensionplasty and Carpometacarpal Joint Replacement in Treatment of Basal Thumb Osteoarthritis: Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT04588961
- Acronym / sponsor ID
- WarsawMU/thumb
- Keywords
- Thumb, Osteoarthritis, Trapeziectomy, Alloplasty, Biomechanics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Oct 2020 (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.
This study compares and evaluates differences in movement analysis, patient-reported outcome, radiological assesment and muscular function between patients undergoing carpometacarpal joint arthroplasty with use of modern implants and trapeziectomy with suspensionplasty
Detailed description
Osteoarthritis of first carpometacarpal joint is the most common degenerative disease of upper limb. According to data available in literature, it affects about 30% of women and 6% of men at the age of 45. Increasing with age, it rises up to 90% in people by the age of 80. Due to more widely spread electronic devices in offices, at work, at home which requires usage of thumb, increase in numbers mentioned above is strongly probable. The main symptoms are: pain, loose of grip strength and loose of function. The latter is most important fact, since about 50% of hand function is possible only with healthy thumb.
In many cases osteoarthritis can be treated by combined NSAIDs and splinting with rehabilitation. Sometimes when symptoms do not respond to non-operative treatment, there is a need for surgery. Trapeziectomy is the most common choice for operative treatment for end-stage basal thumb osteoarthritis. However, many other techniques were developed, there is continuous dispute over selecting the optimal . One of the most promising is arthroplasty using prosthesis. Last years many important advances were made in a design of implant and materials. Moreover the investigators now have many longer outcomes of such operation made in the past. All this data make us think more about using this technique often, since there are papers which show superiority over classical trapeziectomy. Even though there are several studies comparing functional and objective outcome of those techniques, there is a lack of evidence in terms of biomechanical analysis, thenar muscle activity and changes in movement patterns. Moreover there is no study published so far which considers modern implants and trapeziectomy with suspensionplasty. The aim of the study is to examine relationships between movement analysis (kinematic and functional outcomes), patient reported outcome measures (PROMS) and X-ray measurement, electromyography both pre- and post-operatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients would be assigned randomly to 2 different groups
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: Trapeziectomy with suspensionplastyPatients undergoing trapeziectomy with suspensionplasty for primary basal thumb osteoarthritis |
| Study group | Active comparator | Procedure: Joint alloplastyPatients undergoing joint alloplasty using prothesis for primary basal thumb osteoarthritis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- osteoarthritis of carpometacarpal joint III or III/IV in Eaton classification assessed by two different radiologists
- symptoms that do not respond to non-operative treatment for 8 weeks
- no counterindications for anaesthesia
- signed agreement for taking a part into trial
Key exclusion criteria (8 listed)
- patient do not agree to take a part into study
- problems with communication with patient
- unstable cardiac disease
- reoperations
- previous surgical interventions in hand
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 |
|---|---|---|
| Trapeziectomy with suspensionplastySurgical removal of trapezium bone and ligamentoplasty of first metacarpal bone using abductor pollicis tendon | Procedure or surgery | Control group |
| Joint alloplastyAlso: Joint replacementSurgical removal of degenerated joint surfaces nad replacement using modern designed prothesis | Procedure or surgery | Study group |
Primary outcome
Changes in patients reported outcomes - DASH (Disabilities of Arm, Shoulder and Hand)
Time frame: at baseline, 6 weeks and 6 months postoperatively
To measure overall disabilities of upper limb. Results range from 0 to 100, with lower scores corresponding to better outcomes.
12 secondary outcomes
Changes in patients reported outcomes - PRWE (Patient Related Wrist Evaluation)
Time frame: at baseline, 6 weeks and 6 months postoperatively
Changes in patients reported outcomes - Michigan Hand Outcomes Questionaire
Time frame: at baseline, 6 weeks and 6 months postoperatively
Changes in patients reported outcomes - SF-36 (Short Form 36)
Time frame: at baseline, 6 weeks and 6 months postoperatively
Changes in patients reported outcome measures - VAS (Visual Analogue Score)
Time frame: at baseline, 6 weeks and 6 months postoperatively
Changes in carpometacarpal, carpophalangeal and wrist range of motion
Time frame: at baseline, 6 weeks and 6 months postoperatively
Changes in usage of painkillers
Time frame: at baseline, 6 weeks and 6 months postoperatively
Operation related complications
Time frame: at baseline, 6 weeks and 6 months postoperatively
Arthroplasty revision surgeries
Time frame: at baseline, 6 weeks and 6 months postoperatively
Biomechanical 3D motion analysis
Time frame: at baseline, 6 weeks and 6 months postoperatively
Radiological outcome on x-rays
Time frame: at baseline, 6 weeks and 6 months postoperatively
Muscle strength outcomes
Time frame: at baseline, 6 weeks and 6 months postoperatively
EMG measured bioelectrical potentials
Time frame: at baseline, 6 weeks and 6 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- 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 30843103Deiler S. [Basal joint osteoarthritis of the thumb]. Orthopade. 2019 Apr;48(4):351-366. doi: 10.1007/s00132-019-03707-8. German.
- Background: PubMed 29969109Weiss AC, Goodman AD. Thumb Basal Joint Arthritis. J Am Acad Orthop Surg. 2018 Aug 15;26(16):562-571. doi: 10.5435/JAAOS-D-17-00374.
- 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 16701128Mahoney JD, Meals RA. Trapeziectomy. Hand Clin. 2006 May;22(2):165-9. doi: 10.1016/j.hcl.2006.02.003.
- Background: PubMed 27418894Naram A, Lyons K, Rothkopf DM, Calkins ER, Breen T, Jones M, Shufflebarger JV. Increased Complications in Trapeziectomy With Ligament Reconstruction and Tendon Interposition Compared With Trapeziectomy Alone. Hand (N Y). 2016 Mar;11(1):78-82. doi: 10.1177/1558944715617215. Epub 2016 Jan 14.
- Background: PubMed 31876776Sivakumar BS, Graham DJ. APL Lasso Suspensionplasty for Trapeziectomy. Tech Hand Up Extrem Surg. 2020 Sep;24(3):108-113. doi: 10.1097/BTH.0000000000000276.
- Background: PubMed 29595674Wang T, Zhao G, Rui YJ, Mi JY. Outcomes of modified trapeziectomy with ligament reconstruction tendon interposition for the treatment of advanced thumb carpometacarpal arthritis: Two-year follow-up. Medicine (Baltimore). 2018 Mar;97(13):e0235. doi: 10.1097/MD.0000000000010235.
- Background: PubMed 28481387Robles-Molina MJ, Lopez-Caba F, Gomez-Sanchez RC, Cardenas-Grande E, Pajares-Lopez M, Hernandez-Cortes P. Trapeziectomy With Ligament Reconstruction and Tendon Interposition Versus a Trapeziometacarpal Prosthesis for the Treatment of Thumb Basal Joint Osteoarthritis. Orthopedics. 2017 Jul 1;40(4):e681-e686. doi: 10.3928/01477447-20170503-03. Epub 2017 May 8.
- Background: PubMed 30107277Degeorge B, Dagneaux L, Andrin J, Lazerges C, Coulet B, Chammas M. Do trapeziometacarpal prosthesis provide better metacarpophalangeal stability than trapeziectomy and ligamentoplasty? Orthop Traumatol Surg Res. 2018 Nov;104(7):1095-1100. doi: 10.1016/j.otsr.2018.07.008. Epub 2018 Aug 11.
- Background: PubMed 32162998Lane JCE, Rodrigues JN, Furniss D, Burn E, Poulter R, Gardiner MD. Basal thumb osteoarthritis surgery improves health state utility irrespective of technique: a study of UK Hand Registry data. J Hand Surg Eur Vol. 2020 Jun;45(5):436-442. doi: 10.1177/1753193420909753. Epub 2020 Mar 12.
- Background: PubMed 32349588Parker S, Riley N, Dean B; Oxford Upper Limb Collaborative. Management of osteoarthritis at the base of the thumb. Bone Joint J. 2020 May;102-B(5):600-605. doi: 10.1302/0301-620X.102B5.BJJ-2019-1464.R2.
- Individual participant dataSharing planned: Undecided. It is still undecided because number of researchers included in the study is unknown
Related trials for Carpometacarpal Osteoarthritis
Recruiting
Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy
Thumb Osteoarthritis, Thumb Carpometacarpal Joint Osteoarthritis
RecruitingPhase 2
Thumb Base Osteoarthritis: Ultrasound-guided Platelet-rich Plasma Versus Placebo Injection
Thumb Osteoarthritis
RecruitingObservational study
ICF-Based Biopsychosocial Assessment With AI-Assisted Profile Prediction: Trapeziometacarpal Osteoarthritis Model
Trapeziometacarpal Osteoarthritis, Thumb Osteoarthritis
RecruitingPhase 4
Ketorolac in Upper Extremity Tendinopathy and Arthropathy
Osteoarthritis, Tendinopathy
RecruitingObservational study
Study on Basal Joint Arthritis Prospective
Osteoarthrosis of the Carpometacarpal Joint of the Thumb
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.
Piotr Stępiński, MD principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trapeziectomy with suspensionplasty and Joint alloplasty in people with Carpometacarpal Osteoarthritis and Rhizarthrosis, run by Medical University of Warsaw at 1 site in Poland.
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 4 inclusion and 8 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 6 Jan 2021. 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 Poland. 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?
Contact Piotr Stępiński, MD (607 190 402 ext. +48, piotr.stepinski01@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in patients reported outcomes - DASH (Disabilities of Arm, Shoulder and Hand) (time frame: at baseline, 6 weeks and 6 months postoperatively). 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 NCT04588961, which also lists 19 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 6 Jan 2021.