Synovial Hypertrophy Hand (Diagnosis)NCT04648527
Arthroscopic Diagnosis and Treatment of Dorsal Wrist Syndrome in Patients With Synovial Hypertrophy
A study testing arthroscopic synovectomy and thermocoagulation in people with Synovial Hypertrophy Hand (Diagnosis), run by Consorci Sanitari Integral at 1 site in Spain.
Trial summary
The objective of the study is to evaluate de results of the arthroscopic diagnose and arthroscopic treatment of the dorsal wrist pain syndrome associated with dorsal synovial hypertrophy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Synovial Hypertrophy Hand (Diagnosis)
- What is being tested?
- arthroscopic synovectomy and thermocoagulation
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2021to Jan 2023
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women
- Age 18-65 years old, both included
- Diagnose of primary dorsal wrist syndrome, defined as:
- 3.1 Radiocarpal dorsal focal pain 3.2 Pain increases in hyperextension of the wrist and in axial load 3.3 X-rays and MRI without significant findings 3.4 Watson test, extension finger test, Kleinman shuck test, distal radio-ulnar ballottement test, fovea sign all of them negatives and absence of tenosynovitis of the extensor tendons.
- Refractory to conservative treatment consisting in at least 3 months of physical therapy.
- Presence of a hypertrophy of the dorsal synovial of the wrist diagnosed through direct visualization in wrist arthroscopy.
- Other diagnoses excluded through wrist arthroscopy
Who cannot join
- Hand or wrist fractures
- Arthritis
- Carpal boss
- Scapho-lunate ligament tears
- Luno-triquetral ligament tears
- Triangular fibrocartilage tears
Show all 11Show fewer
- Bone necrosis
- Systemic arthritis as rheumatoid arthritis, psoriasic arthritis, gouty arthritis, etc.)
- Dorsal or volar ganglions
- Distal radio-ulnar joint injury or instability
- Hand or wrist infections or tumors
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Dos de Maig, Consorci Sanitari Integral
Barcelona, E-08025
Camila Chanes, MD, +34935072700, cami.chanes@gmail.com
About this study
Official title: Prospective Study of Arthroscopic Diagnosis and Treatment of the Isolated Dorsal Wrist Syndrome in Patients With Hypertrophy of the Dorsal Synovial
The objective of the study is to evaluate de results of the arthroscopic diagnose and arthroscopic treatment of the dorsal wrist pain syndrome associated with dorsal synovial hypertrophy.
It is a prospective study of 25 consecutive patients with the diagnosis of dorsal wrist radiographies and MRI) have discarded other concomitant pathologies. After being refractory to the conservative measures consisting in physiotherapy for at least 3 months, a wrist arthroscopy will be performed with diagnostic and treatment objectives. All these procedures will be performed by the same surgical team. Only will be included those patients whose diagnostic arthroscopy show absence of other concomitant lesions as scapho-lunate or luno-triquetral tears, triangular fibrocartilage injuries, chondral injuries, fractures, arthritis or other injuries that will be considered as exclusion criteria. In those cases where a hypertrophy of the dorsal synovial is confirmed, an arthroscopic synovectomy and radiofrequency thermocoagulation of the hypertrophic synovial will be performed. The standard radiocarpal portals for wrist arthroscopy will be performed: 3-4 portal and 6-R portal.
The pain syndrome described as dorsal localized wrist pain, especially reproductible in hyperextension and axial load of the wrist and in whom the complementary tests (plain The following data will be reviewed and analyzed: age, sex, right/left wrist, right/left-handed, anamnesis, physical exam, MRI findings, arthroscopic diagnosis and functional outcome through Mayo score as a main viable and also, VAS(visual analogue scale for pain), DASH score, grip strength measured with jamar dynamometer and articular balance. All these parameters will be registered pre-surgery and post-surgery at 6 weeks, 3 months and 12 months of the follow-up and at the end of follow-up. The minimum follow-up will be at least of 12 months.
- Conditions
- Synovial Hypertrophy Hand (Diagnosis)
- Being tested
- arthroscopic synovectomy and thermocoagulation
- Keywords
- wrist, arthroscopy, synovectomy
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arthroscopic synovectomy and thermocoagulationProcedure or surgery
An diagnostic arthroscopy and an arthroscopic synovectomy and thermocoagulation of the dorsal hypertrophic synovial will be performed
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Mayo wrist score
Assessment of the changes of Mayo score, before the intervention and at 3 months, 6 months and 12 months after the intervention. The Mayo wrist score ranges from 0 to 100 with a score of 0 indicating a worse wrist condition and 100 indicating a better wrist condition.
Measured: Before intervention, 3 months after intervention, 6 months after intervention, 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study startJan 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Synovial Hypertrophy Hand (Diagnosis)Studies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective before-and-after study
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari Integral
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Camila Chanes Puiggrós, MD, Principal investigator, Hospital Dos de Maig, Consorci Sanitari Integral
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648527
- Sponsor's protocol ID
- 20/31
- Status last verified
- Nov 2020
- First submitted
- 18 Nov 2020
- Last updated
- 1 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Arthroscopic Diagnosis and Treatment of the Isolated Dorsal Wrist Syndrome in Patients With Hypertrophy of the Dorsal Synovial
- ClinicalTrials.gov ID
- NCT04648527
- Acronym / sponsor ID
- 20/31
- Conditions
- Synovial Hypertrophy Hand (Diagnosis)
- Keywords
- wrist, arthroscopy, synovectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Consorci Sanitari IntegralUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 1 Dec 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.
The objective of the study is to evaluate de results of the arthroscopic diagnose and arthroscopic treatment of the dorsal wrist pain syndrome associated with dorsal synovial hypertrophy.
It is a prospective study of 25 consecutive patients with the diagnosis of dorsal wrist radiographies and MRI) have discarded other concomitant pathologies. After being refractory to the conservative measures consisting in physiotherapy for at least 3 months, a wrist arthroscopy will be performed with diagnostic and treatment objectives. All these procedures will be performed by the same surgical team. Only will be included those patients whose diagnostic arthroscopy show absence of other concomitant lesions as scapho-lunate or luno-triquetral tears, triangular fibrocartilage injuries, chondral injuries, fractures, arthritis or other injuries that will be considered as exclusion criteria. In those cases where a hypertrophy of the dorsal synovial is confirmed, an arthroscopic synovectomy and radiofrequency thermocoagulation of the hypertrophic synovial will be performed. The standard radiocarpal portals for wrist arthroscopy will be performed: 3-4 portal and 6-R portal.
The pain syndrome described as dorsal localized wrist pain, especially reproductible in hyperextension and axial load of the wrist and in whom the complementary tests (plain The following data will be reviewed and analyzed: age, sex, right/left wrist, right/left-handed, anamnesis, physical exam, MRI findings, arthroscopic diagnosis and functional outcome through Mayo score as a main viable and also, VAS(visual analogue scale for pain), DASH score, grip strength measured with jamar dynamometer and articular balance. All these parameters will be registered pre-surgery and post-surgery at 6 weeks, 3 months and 12 months of the follow-up and at the end of follow-up. The minimum follow-up will be at least of 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Prospective before-and-after study
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men or women
- Age 18-65 years old, both included
- Diagnose of primary dorsal wrist syndrome, defined as:
- 3.1 Radiocarpal dorsal focal pain 3.2 Pain increases in hyperextension of the wrist and in axial load 3.3 X-rays and MRI without significant findings 3.4 Watson test, extension finger test, Kleinman shuck test, distal radio-ulnar ballottement test, fovea sign all of them negatives and absence of tenosynovitis of the extensor tendons.
- Refractory to conservative treatment consisting in at least 3 months of physical therapy.
Key exclusion criteria (11 listed)
- Hand or wrist fractures
- Arthritis
- Carpal boss
- Scapho-lunate ligament tears
- Luno-triquetral ligament tears
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 |
|---|---|---|
| arthroscopic synovectomy and thermocoagulationAn diagnostic arthroscopy and an arthroscopic synovectomy and thermocoagulation of the dorsal hypertrophic synovial will be performed | Procedure or surgery | – |
Primary outcome
Changes in the Mayo wrist score
Time frame: Before intervention, 3 months after intervention, 6 months after intervention, 12 months after intervention
Assessment of the changes of Mayo score, before the intervention and at 3 months, 6 months and 12 months after the intervention. The Mayo wrist score ranges from 0 to 100 with a score of 0 indicating a worse wrist condition and 100 indicating a better wrist condition.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
- Individual participant dataSharing planned: No
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.
Camila Chanes Puiggrós, MD principal investigator
Hospital Dos de Maig, Consorci Sanitari Integral
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing arthroscopic synovectomy and thermocoagulation in people with Synovial Hypertrophy Hand (Diagnosis), run by Consorci Sanitari Integral at 1 site in Spain.
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 7 inclusion and 11 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 1 Dec 2020. 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 Spain. 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 Camila Chanes Puiggrós, MD (+34935072700, cami.chanes@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Mayo wrist score (time frame: Before intervention, 3 months after intervention, 6 months after intervention, 12 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Dec 2020.