Kienbock DiseaseNCT03291015
Kienbock Disease Radiographic Guided Treatment Versus Arthroscopic Guided Treatment
A study testing radiographic and arthroscopy in people with Kienbock Disease, run by Assiut University.
Trial summary
To Compare Between Radiological Guided Treatment And Arthroscopic Guided Treatment Of KIENBOCK Disease Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Kienbock Disease
- What is being tested?
- radiographic and arthroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2017to 1 Feb 2019
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult persons with average age of 20-60 years.
- Persons coming to outpatient clinic and trauma unit complaining Of Chronic Wrist pain
- Plain x-ray films Antero-posterior View And lateral views of the Wrist
Who cannot join
- Persons < 20 years or > 60 years.
- Traumatic WristWithFracture
- Previous Wrist surgery.
- Patient With Condraindication To plain X-Ray
Trial locations and contacts
No sites are listed yet.
About this study
To Compare Between Radiological Guided Treatment And Arthroscopic Guided Treatment Of KIENBOCK Disease
Read the detailed description
Kienbock'sdisease is defined as avascular necrosis of the lunate bone, which may ultimately progress to lunate sclerosis, collapse, and wrist instability. Incidence is highest in males 20-40 years of age, although it may occur in any age group. Kienbock's disease is uncommon in skeletally immature patients. The cause of Kienbock's disease is likely multi factorial, but potential risk factors have been identified including variant lunate arterial supply and ulnar negative variance. In fewer than 20% of patients, the dorsal blood supply is absent and the lunate is supplied by the palmar radiocarpal arch only; this may represent a risk factor for Kienbock's disease .
Negative ulnar variance may also predispose to Kienbock's disease due to abnormal force loading on the lunate.
Kienbock's disease may be staged according to radiologic appearance using Lichtman classification Stage I is defined as normal radiographic appearance of the lunate with marrow edema present on MRI.
In Stage II disease, there is sclerosis of the lunate, with or without a fracture line, but without lunate collapse.
Stage III, defined as presence of lunate articular surface collapse, may be divided further into three subcategories.
In Stage IIIA, there is no scaphoid rotation; in Stage IIIB, there is fixed scaphoid rotatory subluxation, and in Stage IIIC, a coronal fracture of the lunate is present in addition to scaphoid rotation. Stage III C in 2010 as an addition to the classification scheme.
Stage IV disease is present when secondary radiocarpal or midcarpal osteoarthritis is present in addition to Stage III findings.
An alternate classification of Kienbock's disease, the Bain and Begg
The assessment and management of Kienböck Disease (KD) has always been conundrum. The Lichtman classification has traditionally been used to guide treatment based on imaging. Arthroscopy provides a direct visualization of the articular surface,allows probing of the surfaces, and enables minimally invasive techniques to be performed. The Lichtman-Bain classification is a new classification that takes into account the osseous, vascular, and cartilage aspects of the lunate and the secondary effects on the wrist. It identifies the important prognostic factors including age, the status of the lunate, and the status of the wrist.
With arthroscopy, the articular surfaces of the lunate can be assessed to better understand the status of the lunate. The lunate can be defined as intact, compromised,or not reconstructable. If the lunate is intact then lunate decompression (forage) and arthroscopic assisted bone grafting can be performed. If the lunate facet and capitate are functional, then proximal carpectomy can be performed.
Assessment of the wrist includes assessment of the adjacent articular surfaces of the central column articulations (radiocarpal and midcarpal articulations). Instability of the proximal carpal row can also be assessed. The radioscaphoid articulation is often preserved except in late KD, which allows the scaphocapitate fusion to be a good surgical option. This can now be performed as an arthroscopic procedure. Once the radioscaphoid articulation is degenerate, a salvage procedure is required Wrist arthroscopy is a commonly used procedure that has undergone many modifications and improvements since it was first described. The advent of new portals (both dorsal and volar) means that the wrist joint can be viewed from virtually any perspective ("box concept"). Indications for wrist arthroscopy have continued to expand and include diagnostic and reparative procedures and, more recently, reconstructive, soft-tissue, and bony procedures. Arthroscopic grading of Kienböck's disease better describes articular damage compared with plain radiographs and can help guide surgical treatment options This grading system assists in classifying the severity of the disease and better directs the surgeon toward the reconstructive surgical options grade 0 disorder could be treated with an extra-articular procedure, such as a joint-leveling procedure or revascularization of the lunate. Patients with grade 1or 2a can be treated with a radio-scapho-lunate fusion Patients with grade 1 or 2b can be treated with aproximal-row carpectomy, whereas those with grade 3or 4 require salvage procedures (such as wrist arthrodesis or arthoplasty) Menth-Chiari et al.15 reported on the use of arthroscopic debridement for Kienböck's disease. They reportedexcellent pain relief and improved range of motion in all grades of patients with up to 2 years of follow-up.
- Conditions
- Kienbock Disease
- Being tested
- radiographic, arthroscopy
- Keywords
- arthroscopy, radiographic(plain X ray)
- Medical subject headings
- Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiographicDevice
using plain x ray to determind the treatment plan
arthroscopyDevice
using wrist arthroscopy to determind the treatment plan
| Study group | Role | What they receive |
|---|---|---|
| radiographic guided treatment | Other | radiographic guided treatment of kienbock disease using plain x ray for determine treatment plan Receives: Device: radiographic |
| arthroscopic guided treatment | Other | arthroscopic guided treatment of kienbock disease using wrist arthroscopy for determine treatment plan (Wrist arthroscopy) Receives: Device: arthroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison Between Radiological Guided Treatment(15Patient) And Arthroscopic Guided Treatment(Other 15Patient) Of KIENBOCK Disease
it is found tht 70% ofkienbock disease patient treated by radiographic guided treatment plan is not satisfied sothat we will analyse the persentage of satisfied patient treated by arthroscopic guided treatment plan versus radiographic guided treatment plan
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start1 Oct 2017 (estimated)
- Primary completion1 Dec 2018 (estimated)
- Study completion1 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Kienbock DiseaseStudies 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, Youssef Abdelmalak, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03291015
- Sponsor's protocol ID
- kienbock disease
- Status last verified
- Sep 2017
- First submitted
- 7 Sep 2017
- Last updated
- 25 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nealey EM, Petscavage-Thomas JM, Chew FS, Allan CH, Ha AS. Radiologic Guide to Surgical Treatment of Kienbock's Disease. Curr Probl Diagn Radiol. 2018 Mar-Apr;47(2):103-109. doi: 10.1067/j.cpradiol.2017.04.012. Epub 2017 Apr 25.
PubMed 28619441Lichtman DM, Lesley NE, Simmons SP. The classification and treatment of Kienbock's disease: the state of the art and a look at the future. J Hand Surg Eur Vol. 2010 Sep;35(7):549-54. doi: 10.1177/1753193410374690. Epub 2010 Jul 9.
PubMed 20621943Stahl S, Stahl AS, Meisner C, Hentschel PJH, Valina S, Luz O, Schaller HE, Lotter O. Critical analysis of causality between negative ulnar variance and Kienbock disease. Plast Reconstr Surg. 2013 Oct;132(4):899-909. doi: 10.1097/PRS.0b013e31829f4a2c.
PubMed 24076682Roth JH, Poehling GG, Whipple TL. Arthroscopic surgery of the wrist. Instr Course Lect. 1988;37:183-94.
PubMed 3418121Bain GI, Munt J, Turner PC. New advances in wrist arthroscopy. Arthroscopy. 2008 Mar;24(3):355-67. doi: 10.1016/j.arthro.2007.11.002. Epub 2008 Jan 29.
PubMed 18308189Bain GI, Begg M. Arthroscopic assessment and classification of Kienbock's disease. Tech Hand Up Extrem Surg. 2006 Mar;10(1):8-13. doi: 10.1097/00130911-200603000-00003.
PubMed 16628114Bain GI, MacLean SB, Tse WL, Ho PC, Lichtman DM. Kienbock Disease and Arthroscopy: Assessment, Classification, and Treatment. J Wrist Surg. 2016 Nov;5(4):255-260. doi: 10.1055/s-0036-1584546. Epub 2016 Jun 20.
PubMed 27777814Bain GI, Durrant A. An articular-based approach to Kienbock avascular necrosis of the lunate. Tech Hand Up Extrem Surg. 2011 Mar;15(1):41-7. doi: 10.1097/BTH.0b013e31820e82e8.
PubMed 21358525
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kienbock Disease Radiographic Guided Treatment Versus Arthroscopic Guided Treatment
- ClinicalTrials.gov ID
- NCT03291015
- Acronym / sponsor ID
- kienbock disease
- Conditions
- Kienbock Disease
- Keywords
- arthroscopy, radiographic(plain X ray)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (estimated)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 1 Feb 2019 (estimated)
- First posted
- 25 Sep 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.
To Compare Between Radiological Guided Treatment And Arthroscopic Guided Treatment Of KIENBOCK Disease
Detailed description
Kienbock'sdisease is defined as avascular necrosis of the lunate bone, which may ultimately progress to lunate sclerosis, collapse, and wrist instability. Incidence is highest in males 20-40 years of age, although it may occur in any age group. Kienbock's disease is uncommon in skeletally immature patients. The cause of Kienbock's disease is likely multi factorial, but potential risk factors have been identified including variant lunate arterial supply and ulnar negative variance. In fewer than 20% of patients, the dorsal blood supply is absent and the lunate is supplied by the palmar radiocarpal arch only; this may represent a risk factor for Kienbock's disease .
Negative ulnar variance may also predispose to Kienbock's disease due to abnormal force loading on the lunate.
Kienbock's disease may be staged according to radiologic appearance using Lichtman classification Stage I is defined as normal radiographic appearance of the lunate with marrow edema present on MRI.
In Stage II disease, there is sclerosis of the lunate, with or without a fracture line, but without lunate collapse.
Stage III, defined as presence of lunate articular surface collapse, may be divided further into three subcategories.
In Stage IIIA, there is no scaphoid rotation; in Stage IIIB, there is fixed scaphoid rotatory subluxation, and in Stage IIIC, a coronal fracture of the lunate is present in addition to scaphoid rotation. Stage III C in 2010 as an addition to the classification scheme.
Stage IV disease is present when secondary radiocarpal or midcarpal osteoarthritis is present in addition to Stage III findings.
An alternate classification of Kienbock's disease, the Bain and Begg
The assessment and management of Kienböck Disease (KD) has always been conundrum. The Lichtman classification has traditionally been used to guide treatment based on imaging. Arthroscopy provides a direct visualization of the articular surface,allows probing of the surfaces, and enables minimally invasive techniques to be performed. The Lichtman-Bain classification is a new classification that takes into account the osseous, vascular, and cartilage aspects of the lunate and the secondary effects on the wrist. It identifies the important prognostic factors including age, the status of the lunate, and the status of the wrist.
With arthroscopy, the articular surfaces of the lunate can be assessed to better understand the status of the lunate. The lunate can be defined as intact, compromised,or not reconstructable. If the lunate is intact then lunate decompression (forage) and arthroscopic assisted bone grafting can be performed. If the lunate facet and capitate are functional, then proximal carpectomy can be performed.
Assessment of the wrist includes assessment of the adjacent articular surfaces of the central column articulations (radiocarpal and midcarpal articulations). Instability of the proximal carpal row can also be assessed. The radioscaphoid articulation is often preserved except in late KD, which allows the scaphocapitate fusion to be a good surgical option. This can now be performed as an arthroscopic procedure. Once the radioscaphoid articulation is degenerate, a salvage procedure is required Wrist arthroscopy is a commonly used procedure that has undergone many modifications and improvements since it was first described. The advent of new portals (both dorsal and volar) means that the wrist joint can be viewed from virtually any perspective ("box concept"). Indications for wrist arthroscopy have continued to expand and include diagnostic and reparative procedures and, more recently, reconstructive, soft-tissue, and bony procedures. Arthroscopic grading of Kienböck's disease better describes articular damage compared with plain radiographs and can help guide surgical treatment options This grading system assists in classifying the severity of the disease and better directs the surgeon toward the reconstructive surgical options grade 0 disorder could be treated with an extra-articular procedure, such as a joint-leveling procedure or revascularization of the lunate. Patients with grade 1or 2a can be treated with a radio-scapho-lunate fusion Patients with grade 1 or 2b can be treated with aproximal-row carpectomy, whereas those with grade 3or 4 require salvage procedures (such as wrist arthrodesis or arthoplasty) Menth-Chiari et al.15 reported on the use of arthroscopic debridement for Kienböck's disease. They reportedexcellent pain relief and improved range of motion in all grades of patients with up to 2 years of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| radiographic guided treatment | Other | Device: radiographicradiographic guided treatment of kienbock disease using plain x ray for determine treatment plan |
| arthroscopic guided treatment | Other | Device: arthroscopyarthroscopic guided treatment of kienbock disease using wrist arthroscopy for determine treatment plan (Wrist arthroscopy) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult persons with average age of 20-60 years.
- Persons coming to outpatient clinic and trauma unit complaining Of Chronic Wrist pain
- Plain x-ray films Antero-posterior View And lateral views of the Wrist
Key exclusion criteria (4 listed)
- Persons < 20 years or > 60 years.
- Traumatic WristWithFracture
- Previous Wrist surgery.
- Patient With Condraindication To plain X-Ray
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 |
|---|---|---|
| radiographicusing plain x ray to determind the treatment plan | Device | radiographic guided treatment |
| arthroscopyusing wrist arthroscopy to determind the treatment plan | Device | arthroscopic guided treatment |
Primary outcome
Comparison Between Radiological Guided Treatment(15Patient) And Arthroscopic Guided Treatment(Other 15Patient) Of KIENBOCK Disease
Time frame: baseline
it is found tht 70% ofkienbock disease patient treated by radiographic guided treatment plan is not satisfied sothat we will analyse the persentage of satisfied patient treated by arthroscopic guided treatment plan versus radiographic guided treatment plan
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Background: PubMed 28619441Nealey EM, Petscavage-Thomas JM, Chew FS, Allan CH, Ha AS. Radiologic Guide to Surgical Treatment of Kienbock's Disease. Curr Probl Diagn Radiol. 2018 Mar-Apr;47(2):103-109. doi: 10.1067/j.cpradiol.2017.04.012. Epub 2017 Apr 25.
- Background: PubMed 20621943Lichtman DM, Lesley NE, Simmons SP. The classification and treatment of Kienbock's disease: the state of the art and a look at the future. J Hand Surg Eur Vol. 2010 Sep;35(7):549-54. doi: 10.1177/1753193410374690. Epub 2010 Jul 9.
- Background: PubMed 24076682Stahl S, Stahl AS, Meisner C, Hentschel PJH, Valina S, Luz O, Schaller HE, Lotter O. Critical analysis of causality between negative ulnar variance and Kienbock disease. Plast Reconstr Surg. 2013 Oct;132(4):899-909. doi: 10.1097/PRS.0b013e31829f4a2c.
- Background: PubMed 3418121Roth JH, Poehling GG, Whipple TL. Arthroscopic surgery of the wrist. Instr Course Lect. 1988;37:183-94.
- Background: PubMed 18308189Bain GI, Munt J, Turner PC. New advances in wrist arthroscopy. Arthroscopy. 2008 Mar;24(3):355-67. doi: 10.1016/j.arthro.2007.11.002. Epub 2008 Jan 29.
- Background: PubMed 16628114Bain GI, Begg M. Arthroscopic assessment and classification of Kienbock's disease. Tech Hand Up Extrem Surg. 2006 Mar;10(1):8-13. doi: 10.1097/00130911-200603000-00003.
- Background: PubMed 27777814Bain GI, MacLean SB, Tse WL, Ho PC, Lichtman DM. Kienbock Disease and Arthroscopy: Assessment, Classification, and Treatment. J Wrist Surg. 2016 Nov;5(4):255-260. doi: 10.1055/s-0036-1584546. Epub 2016 Jun 20.
- Background: PubMed 21358525Bain GI, Durrant A. An articular-based approach to Kienbock avascular necrosis of the lunate. Tech Hand Up Extrem Surg. 2011 Mar;15(1):41-7. doi: 10.1097/BTH.0b013e31820e82e8.
Related trials for Kienbock Disease
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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 radiographic and arthroscopy in people with Kienbock Disease, 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 3 inclusion and 4 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 25 Sep 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 youssef zaki, resident (01222364028, youssefmalak33@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison Between Radiological Guided Treatment(15Patient) And Arthroscopic Guided Treatment(Other 15Patient) Of KIENBOCK Disease (time frame: baseline). 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 NCT03291015, which also lists 8 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 25 Sep 2017.