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

Ex-vivo Preparat of Femoral Head Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03016299
• Other study ID #: 0167-16-MMC
• Status: Not yet recruiting
• Phase: N/A
• First received: November 16, 2016
• Last updated: January 8, 2017
• Start date: December 2016
• Est. completion date: July 2017

Study information

• Verified date: November 2016
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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 Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Ex-vivo Preparat of Femoral Head
• Partial or Total Hip Arthroplasty

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

References & Publications (10)

Alam K. Exploring thermal anisotropy of cortical bone using temperature measurements in drilling. Biomed Mater Eng. 2016 May 12;27(1):39-48. doi: 10.3233/BME-161566. — View Citation

Augustin G, Davila S, Udilljak T, Staroveski T, Brezak D, Babic S. Temperature changes during cortical bone drilling with a newly designed step drill and an internally cooled drill. Int Orthop. 2012 Jul;36(7):1449-56. doi: 10.1007/s00264-012-1491-z. — View Citation

Chen H, Hoemann CD, Sun J, Chevrier A, McKee MD, Shive MS, Hurtig M, Buschmann MD. Depth of subchondral perforation influences the outcome of bone marrow stimulation cartilage repair. J Orthop Res. 2011 Aug;29(8):1178-84. doi: 10.1002/jor.21386. — View Citation

Chen H, Sun J, Hoemann CD, Lascau-Coman V, Ouyang W, McKee MD, Shive MS, Buschmann MD. Drilling and microfracture lead to different bone structure and necrosis during bone-marrow stimulation for cartilage repair. J Orthop Res. 2009 Nov;27(11):1432-8. doi: 10.1002/jor.20905. — View Citation

Eriksson AR, Albrektsson T. Temperature threshold levels for heat-induced bone tissue injury: a vital-microscopic study in the rabbit. J Prosthet Dent. 1983 Jul;50(1):101-7. — View Citation

Hayashi K, Kumai T, Higashiyama I, Shinohara Y, Matsuda T, Takakura Y. Repair process after fibrocartilaginous enthesis drilling: histological study in a rabbit model. J Orthop Sci. 2009 Jan;14(1):76-84. doi: 10.1007/s00776-008-1284-9. — View Citation

Menche DS, Frenkel SR, Blair B, Watnik NF, Toolan BC, Yaghoubian RS, Pitman MI. A comparison of abrasion burr arthroplasty and subchondral drilling in the treatment of full-thickness cartilage lesions in the rabbit. Arthroscopy. 1996 Jun;12(3):280-6. — View Citation

Möhlhenrich SC, Abouridouane M, Heussen N, Hölzle F, Klocke F, Modabber A. Thermal evaluation by infrared measurement of implant site preparation between single and gradual drilling in artificial bone blocks of different densities. Int J Oral Maxillofac Surg. 2016 Nov;45(11):1478-1484. doi: 10.1016/j.ijom.2016.05.020. — View Citation

Orth P, Goebel L, Wolfram U, Ong MF, Gräber S, Kohn D, Cucchiarini M, Ignatius A, Pape D, Madry H. Effect of subchondral drilling on the microarchitecture of subchondral bone: analysis in a large animal model at 6 months. Am J Sports Med. 2012 Apr;40(4):828-36. doi: 10.1177/0363546511430376. — View Citation

Singh G, Jain V, Gupta D, Ghai A. Optimization of process parameters for drilled hole quality characteristics during cortical bone drilling using Taguchi method. J Mech Behav Biomed Mater. 2016 Sep;62:355-65. doi: 10.1016/j.jmbbm.2016.05.015. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	histological damage	microscopically assesing the histological damage to Human chondral & Subchondral tissue in 3 common microfractures techniques ( morphological description)	withing 48 Hours after specimen fixation	No