search
Back to results

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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kienbock Disease focused on measuring arthroscopy, radiographic(plain X ray)

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    September 7, 2017
    Last Updated
    September 19, 2017
    Sponsor
    Assiut University
    search

    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