Wrist ImpactionNCT03168646
Arthroscopic Wafer and Ulnar Shortening in Ulnar Abutment
A study testing wafer procedure and arthroscopy and ulnar shortening osteotomy in people with Wrist Impaction, run by Assiut University.
Trial summary
there are many management options of ulnocarpal abutment depends on clinical evaluation and imaging of this joint. Arthroscopic treatment is the simplest solution for these conditions. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Wrist Impaction
- What is being tested?
- wafer procedure and arthroscopy and ulnar shortening osteotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2017to Jun 2020
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- obvious ulnar abutment syndrome with ulnar side wrist pain
Who cannot join
- ulnar minus or neutral variance
- central and radial wrist pain
- osteoarthritis of the wrist.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Study Between Arthroscopic Wafer and Ulnar Shortening Osteotomy in Ulnar Abutment Syndrome
there are many management options of ulnocarpal abutment depends on clinical evaluation and imaging of this joint. Arthroscopic treatment is the simplest solution for these conditions.
- Conditions
- Wrist Impaction
- Being tested
- wafer procedure, arthroscopy and ulnar shortening osteotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wafer procedureProcedure or surgery
wrist arthroscopy and debridement of Triangular fibrocartilage and shortening of the head ulna by burr
arthroscopy and ulnar shortening osteotomyProcedure or surgery
wrist arthroscopy,debride debridement of Triangular fibrocartilage and shortening of the ulna by osteotomy and plate
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Active comparator | wafer group procedure using an arthroscope through portal(radial to extensor carpi ulnaris, debridement of triangular fibro-cartilage complex 3-4 mm is shaved from the dome of the ulna by 2.9 bur. Receives: Procedure: wafer procedure |
| group 2 | Active comparator | ulnar shortening group :this is the most logical technique, dorsoulnar incision is made on the distal one-third of the forearm then a 6 hole 3.5 mm Dcp plate is position,osteotomy using oscillating saw in z-shaped manner. Receives: Procedure: arthroscopy and ulnar shortening osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
mayo scoring system
follow up of the pain( nonpain,mild occasional, moderate and sever graded as 1,2,3,4 respectively
Measured: 6 month
mayo scoring system
Range of motion of the wrist compared to the normal side(100 ,75-99,50-74,25-9,0-24%
Measured: 6 month
mayo scoring system
grip strength
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study startJun 2017 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Wrist ImpactionStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abd Elaziz Monsef Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03168646
- Sponsor's protocol ID
- WAFER
- Status last verified
- May 2017
- First submitted
- 16 May 2017
- Last updated
- 31 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stockton DJ, Pelletier ME, Pike JM. Operative treatment of ulnar impaction syndrome: a systematic review. J Hand Surg Eur Vol. 2015 Jun;40(5):470-6. doi: 10.1177/1753193414541749. Epub 2014 Jul 30.
PubMed 25080480Kaufman D, Etcheson J, Yao J. Microfracture for Ulnar Impaction Syndrome: Surgical Technique and Outcomes with Minimum 2-Year Follow-up. J Wrist Surg. 2017 Feb;6(1):60-64. doi: 10.1055/s-0036-1586496. Epub 2016 Aug 5.
PubMed 28119797Colantoni J, Chadderdon C, Gaston RG. Arthroscopic wafer procedure for ulnar impaction syndrome. Arthrosc Tech. 2014 Jan 24;3(1):e123-5. doi: 10.1016/j.eats.2013.09.008. eCollection 2014 Feb.
PubMed 24749031
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Arthroscopic Wafer and Ulnar Shortening Osteotomy in Ulnar Abutment Syndrome
- ClinicalTrials.gov ID
- NCT03168646
- Acronym / sponsor ID
- WAFER
- Conditions
- Wrist Impaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2017 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 30 May 2017 (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.
there are many management options of ulnocarpal abutment depends on clinical evaluation and imaging of this joint. Arthroscopic treatment is the simplest solution for these conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Active comparator | Procedure: wafer procedurewafer group procedure using an arthroscope through portal(radial to extensor carpi ulnaris, debridement of triangular fibro-cartilage complex 3-4 mm is shaved from the dome of the ulna by 2.9 bur. |
| group 2 | Active comparator | Procedure: arthroscopy and ulnar shortening osteotomyulnar shortening group :this is the most logical technique, dorsoulnar incision is made on the distal one-third of the forearm then a 6 hole 3.5 mm Dcp plate is position,osteotomy using oscillating saw in z-shaped manner. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- obvious ulnar abutment syndrome with ulnar side wrist pain
Key exclusion criteria (3 listed)
- ulnar minus or neutral variance
- central and radial wrist pain
- osteoarthritis of the wrist.
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 |
|---|---|---|
| wafer procedurewrist arthroscopy and debridement of Triangular fibrocartilage and shortening of the head ulna by burr | Procedure or surgery | group 1 |
| arthroscopy and ulnar shortening osteotomywrist arthroscopy,debride debridement of Triangular fibrocartilage and shortening of the ulna by osteotomy and plate | Procedure or surgery | group 2 |
Primary outcome
mayo scoring system
Time frame: 6 month
follow up of the pain( nonpain,mild occasional, moderate and sever graded as 1,2,3,4 respectively
mayo scoring system
Time frame: 6 month
Range of motion of the wrist compared to the normal side(100 ,75-99,50-74,25-9,0-24%
mayo scoring system
Time frame: 6 month
grip strength
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Background: PubMed 25080480Stockton DJ, Pelletier ME, Pike JM. Operative treatment of ulnar impaction syndrome: a systematic review. J Hand Surg Eur Vol. 2015 Jun;40(5):470-6. doi: 10.1177/1753193414541749. Epub 2014 Jul 30.
- Background: PubMed 28119797Kaufman D, Etcheson J, Yao J. Microfracture for Ulnar Impaction Syndrome: Surgical Technique and Outcomes with Minimum 2-Year Follow-up. J Wrist Surg. 2017 Feb;6(1):60-64. doi: 10.1055/s-0036-1586496. Epub 2016 Aug 5.
- Background: PubMed 24749031Colantoni J, Chadderdon C, Gaston RG. Arthroscopic wafer procedure for ulnar impaction syndrome. Arthrosc Tech. 2014 Jan 24;3(1):e123-5. doi: 10.1016/j.eats.2013.09.008. eCollection 2014 Feb.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing wafer procedure and arthroscopy and ulnar shortening osteotomy in people with Wrist Impaction, run by Assiut University.
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 1 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 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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 Amr El-Sayed Ali (00201099021770, amrelmicro@YAHOO.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mayo scoring system (time frame: 6 month). The study lists 3 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 NCT03168646, which also lists 3 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 31 May 2017.