Orthopedic DisorderNCT05746091
Arthroscopic Partial Trapezictomy With Hematoma Distraction in Basal Thumb Arthritis
A study testing wrist arthroscopy in people with Orthopedic Disorder, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The basal joint, also referred to as the carpometacarpal (CMC) joint, of the thumb is one of the joints most commonly affected by arthritis. CMC joint arthritis can lead to decreased grip and pinch strength and impairment of activities of daily living Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Orthopedic Disorder
- What is being tested?
- wrist arthroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Dec 2023to 5 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: adult patient > 20years.
- Gender: Males \& Females.
- Symptomtic patient.
- Failed conservative treatment of 6 months duration
- Eaton stage II, III and IV of base thumb arthritis
Who cannot join
- Patient presenting with flexor carpi radialis rupture
- Previous Zancolli arthroplasty
- Associated comorbidity as: RA,DM with joint destruction
- Infection
- Poor Skin Condition
- Active Pateint With High Joint Demand
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arthroscopic Partial Trapeziectomy With Hematoma Distraction in Basal Thumb Arthritis
The basal joint, also referred to as the carpometacarpal (CMC) joint, of the thumb is one of the joints most commonly affected by arthritis. CMC joint arthritis can lead to decreased grip and pinch strength and impairment of activities of daily living
Read the detailed description
The thumb CMC joint has been reported as the most painful joint when compared to other hand joints affected by OA. It is therefore no surprise that this is a common chief complaint of patients and has a significant effect on work and life satisfaction Patients often present with complaints of pain localized to the base of the thumb that is exacerbated when performing tasks such as opening a jar, turning a car key, and turning door Knob, this pain may be reproduced by resisted pinch and grip .
On physical examination, patients will have point tenderness at the thumb basal joint with swelling and crepitus when the basal joint is compressed - a positive grind test and a positive "hump" sign from dorsal CMC dislocation subluxation .
- Conditions
- Orthopedic Disorder
- Being tested
- wrist arthroscopy
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wrist arthroscopyProcedure or surgery
Arthroscopic Partial Trapeziectomy with Hematoma Distraction in Basal Thumb Arthritis
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic partial Trapezictomy With Hematoma Distraction | Experimental | Not described Receives: Procedure: wrist arthroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
DASH score
score for pinch grip
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start30 Dec 2023
- Primary completion1 Oct 2024 (estimated)
- Study completion5 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abbas Mahmoud, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746091
- Sponsor's protocol ID
- APTBA
- Status last verified
- Jan 2024
- First submitted
- 17 Feb 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Partial Trapeziectomy With Hematoma Distraction in Basal Thumb Arthritis
- ClinicalTrials.gov ID
- NCT05746091
- Acronym / sponsor ID
- APTBA
- Conditions
- Orthopedic Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 30 Dec 2023 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 5 Dec 2024 (estimated)
- First posted
- 27 Feb 2023 (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 basal joint, also referred to as the carpometacarpal (CMC) joint, of the thumb is one of the joints most commonly affected by arthritis. CMC joint arthritis can lead to decreased grip and pinch strength and impairment of activities of daily living
Detailed description
The thumb CMC joint has been reported as the most painful joint when compared to other hand joints affected by OA. It is therefore no surprise that this is a common chief complaint of patients and has a significant effect on work and life satisfaction Patients often present with complaints of pain localized to the base of the thumb that is exacerbated when performing tasks such as opening a jar, turning a car key, and turning door Knob, this pain may be reproduced by resisted pinch and grip .
On physical examination, patients will have point tenderness at the thumb basal joint with swelling and crepitus when the basal joint is compressed - a positive grind test and a positive "hump" sign from dorsal CMC dislocation subluxation .
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic partial Trapezictomy With Hematoma Distraction | Experimental | Procedure: wrist arthroscopy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: adult patient > 20years.
- Gender: Males \& Females.
- Symptomtic patient.
- Failed conservative treatment of 6 months duration
- Eaton stage II, III and IV of base thumb arthritis
Key exclusion criteria (6 listed)
- Patient presenting with flexor carpi radialis rupture
- Previous Zancolli arthroplasty
- Associated comorbidity as: RA,DM with joint destruction
- Infection
- Poor Skin Condition
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 |
|---|---|---|
| wrist arthroscopyArthroscopic Partial Trapeziectomy with Hematoma Distraction in Basal Thumb Arthritis | Procedure or surgery | Arthroscopic partial Trapezictomy With Hematoma Distraction |
Primary outcome
DASH score
Time frame: 1 year
score for pinch grip
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
Related trials for Orthopedic Disorder
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wrist arthroscopy in people with Orthopedic Disorder, run by Al-Azhar University at 1 site in Egypt.
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 5 inclusion and 6 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 17 Jan 2024. 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 Egypt. 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 Maysara Mohammed, MD (0201063119673, maysarabayoumy.216@Azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DASH score (time frame: 1 year). 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 17 Jan 2024.