Kienbock Disease Radiographic Guided Treatment Versus Arthroscopic Guided Treatment

September 19, 2017 updated by: Youssef Abdelmalak, Assiut University
To Compare Between Radiological Guided Treatment And Arthroscopic Guided Treatment Of KIENBOCK Disease

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: radiographic guided treatment
radiographic guided treatment of kienbock disease using plain x ray for determine treatment plan
Device: radiographic
using plain x ray to determind the treatment plan
Other: arthroscopic guided treatment
arthroscopic guided treatment of kienbock disease using wrist arthroscopy for determine treatment plan (Wrist arthroscopy)
Device: arthroscopy
using wrist arthroscopy to determind the treatment plan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2017

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

February 1, 2019

Study Registration Dates

First Submitted

September 7, 2017

First Submitted That Met QC Criteria

September 19, 2017

First Posted (Actual)

September 25, 2017

Study Record Updates

Last Update Posted (Actual)

September 25, 2017

Last Update Submitted That Met QC Criteria

September 19, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • kienbock disease

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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