Kienbock Disease Radiographic Guided Treatment Versus Arthroscopic Guided Treatment
Primary Purpose
Kienbock Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
radiographic
arthroscopy
Sponsored by
About this trial
This is an interventional treatment trial for Kienbock Disease focused on measuring arthroscopy, radiographic(plain X ray)
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Persons < 20 years or > 60 years.
- Traumatic WristWithFracture
- Previous Wrist surgery.
- Patient With Condraindication To plain X-Ray
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
radiographic guided treatment
arthroscopic guided treatment
Arm Description
radiographic guided treatment of kienbock disease using plain x ray for determine treatment plan
arthroscopic guided treatment of kienbock disease using wrist arthroscopy for determine treatment plan (Wrist arthroscopy)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03291015
First Posted
September 7, 2017
Last Updated
September 19, 2017
Sponsor
Assiut University
1. Study Identification
Unique Protocol Identification Number
NCT03291015
Brief Title
Kienbock Disease Radiographic Guided Treatment Versus Arthroscopic Guided Treatment
Official Title
Kienbock Disease Radiographic Guided Treatment Versus Arthroscopic Guided Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2017 (Anticipated)
Primary Completion Date
December 1, 2018 (Anticipated)
Study Completion Date
February 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kienbock Disease
Keywords
arthroscopy, radiographic(plain X ray)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
radiographic guided treatment
Arm Type
Other
Arm Description
radiographic guided treatment of kienbock disease using plain x ray for determine treatment plan
Arm Title
arthroscopic guided treatment
Arm Type
Other
Arm Description
arthroscopic guided treatment of kienbock disease using wrist arthroscopy for determine treatment plan (Wrist arthroscopy)
Intervention Type
Device
Intervention Name(s)
radiographic
Intervention Description
using plain x ray to determind the treatment plan
Intervention Type
Device
Intervention Name(s)
arthroscopy
Intervention Description
using wrist arthroscopy to determind the treatment plan
Primary Outcome Measure Information:
Title
Comparison Between Radiological Guided Treatment(15Patient) And Arthroscopic Guided Treatment(Other 15Patient) Of KIENBOCK Disease
Description
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
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Persons < 20 years or > 60 years.
Traumatic WristWithFracture
Previous Wrist surgery.
Patient With Condraindication To plain X-Ray
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
youssef zaki, resident
Phone
01222364028
Email
youssefmalak33@yahoo.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
28619441
Citation
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.
Results Reference
background
PubMed Identifier
20621943
Citation
Lichtman 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.
Results Reference
background
PubMed Identifier
24076682
Citation
Stahl 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.
Results Reference
background
PubMed Identifier
3418121
Citation
Roth JH, Poehling GG, Whipple TL. Arthroscopic surgery of the wrist. Instr Course Lect. 1988;37:183-94.
Results Reference
background
PubMed Identifier
18308189
Citation
Bain 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.
Results Reference
background
PubMed Identifier
16628114
Citation
Bain 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.
Results Reference
background
PubMed Identifier
27777814
Citation
Bain 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.
Results Reference
background
PubMed Identifier
21358525
Citation
Bain 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.
Results Reference
background
Learn more about this trial
Kienbock Disease Radiographic Guided Treatment Versus Arthroscopic Guided Treatment
We'll reach out to this number within 24 hrs