The Histological Effect of Various Microfracture Techniques on Human Chondral & Sub-chondral Tissue - an Ex-Vivo Study

January 8, 2017 updated by: Meir Medical Center

The subchondral bone, formed by the subchondral bone plate and the subarticular spongiosa, plays a key role in supporting the articular cartilage. Marrow stimulation techniques such as subchondral drilling are clinically important treatment options for symptomatic small cartilage defects. However, The heat generated from the metal-bone interface during drilling due to the friction can cause thermal osteonecrosis. , recent clinical evidence suggests that they may induce alterations in the subchondral bone plate such as intralesional osteophytes, which persist and may play a role in the degeneration of the repair tissue.

Little is known about whether they induce deleterious changes in the Human Chondral & Subchondral bone.

The aim of this study was to compare the condral & Sub-chondral Histoligical damage induced by different drilling techniques.

To the best of our knowledge this is the first time to inspect it, In- Situ, on Human tissue.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Chronic articular cartilage defects do not heal spontaneously. However, acute traumatic osteochondral lesions or surgically inflicted lesions extending into subchondral bone, spongialization, abrasion or microfracture by drilling causing the release of pluripotent mesenchymal stem cells from the bone marrow, may heal with repair tissue consisting of fibrous tissue, fibrocartilage or hyaline-like cartilage. There for Marrow stimulation techniques as subchondral drilling or microfractures represent ones of the most frequently used methods for chondral and osteochodral defects repair and considered as standard techniques. [10-12]

It's well know and logical to understand that the high temperature around the drilling hole can lead to thermal injury. [1] Temperatures over 47 C degrees for one minutes are associated thermal osteonecrosis [2,3]. The presence of this necrotic bone may delay healing and predispose to infection.[1] Many studies evaluate the thermal necrosis of the drill into the bone [3-6]. In case of osteochondral lesion, drilling of the injury area is the most common practice in orthopedics surgeries for knee, hip, talus and others. In one study that evaluate the difference between drilling and microfractures and the impact in the cartilage healing revealed distinct differences between microfracture and drilling for acute subchondral bone structure and osteocyte necrosis {4] other study evaluate the healing difference between drilling and burring in rabbits knee, showing degenerative changes in both technique and histology longer lived repair the cartilage with 2 mm drilling[5] The main objective of this study is to evaluate for first time in humans, best to our knowledge, the difference between drilling with KWires compared to drill in terms of thermal osteonecrosis and histo-pathological damage.

Methodes:

The specimens will be achieved from 2 groups of patients. The first group correspond to traumatic subcapital fractures with previous non hip pain complains No osteoarthritis changes in the x-ray. The second group the specimens achieve from hip arthroplasty surgery due to osteoarthritic changes.

The femoral head will be obtain during surgery. Drill will be performed in 3 contiguous areas. First Area by Nailing, Second by KW drilling and 3rd area drilled by regular drill obtaining a triangle with the three drilled epicenters. All will be tested with 2 different diameters - 3.5 mm & 1.75mm. All 3 methods will be checked with and without cooling - by laviation with saline during the drilling/nailing. Temperature measurements using Thermocouples having 1 mm wire diameter will be used for temperature measurement.

Parameters as Drilling speed, Drilling depth and Orientation to line of sress- trabeculae- would be uniform.

Histological aspect:

The specimen will be fixed with adequate amount of buffered 4% formalin for 24 to 48 hours with subsequent gentle decalcification in ethylenediaminetetraacetic acid. Then, the specimen will be cut with a strong knife/ or scalpel into parallel slices 3 to 5 mm thick and washed in running water for 12 hours. And after this, the sections from abnormal areas, including articular surface will be submitted for paraffin embedding.

The histological slides will be stained by hematoxilin-eosin (H&E), PAS, Masson trichrome, and Alcian blue. The lesions (degeneration, hemorrhage, necrosis and others) will be measured by micrometer in the microscope.

Study Type

Observational

Enrollment (Anticipated)

40

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 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

all Adults who went through partial or complete replacement of the hip in our institute

Description

Inclusion Criteria:

  • adults over 18 who agreed to participate in the study and signed an informed consent form.
  • Patients who went through partial or complete arthroplasty of the hip due to traumatic or degenerative changes - respectively.

Exclusion Criteria:

  • The refusal of the patient to use sampling for any reason, including the desire for burying the organ / tissue
  • rheumatic - autoimmune diseases that may affect the hip joint (eg: psoriasis, rheumatoid arthritis, stc')
  • Any chonic medications usage that might affect bone and cartilage (eg: Bifosfantim, Alendronate, Risedronate, Ibandronate)
  • Any suspected pathology of bone: malignancies, infections, Avascular Necrosis etc'

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Osteoarthritis hip joint
specimen of head of femur will be used- after total hip arthroplasty (due to Degenerative Osteoarthritis hip joint )
Procedure: microfracture techniques
Drill will be performed in 3 contiguous areas. First Area by Nailing, Second by KW drilling and 3rd area drilled by regular drill obtaining a triangle with the three drilled epicenters.
Non-Osteoarthritis hip joint
specimen of head of femur will be used- after Hip Hemiarthroplasty -Partial replacment (due to traumatic fracture)
Procedure: microfracture techniques
Drill will be performed in 3 contiguous areas. First Area by Nailing, Second by KW drilling and 3rd area drilled by regular drill obtaining a triangle with the three drilled epicenters.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
histological damage
Time Frame: withing 48 Hours after specimen fixation
microscopically assesing the histological damage to Human chondral & Subchondral tissue in 3 common microfractures techniques ( morphological description)
withing 48 Hours after specimen fixation

Collaborators and Investigators

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

Sponsor

Meir Medical Center

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

December 1, 2016

Primary Completion (ANTICIPATED)

June 1, 2017

Study Completion (ANTICIPATED)

July 1, 2017

Study Registration Dates

First Submitted

November 16, 2016

First Submitted That Met QC Criteria

January 8, 2017

First Posted (ESTIMATE)

January 10, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

January 10, 2017

Last Update Submitted That Met QC Criteria

January 8, 2017

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0167-16-MMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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