Partial or Total Hip ArthroplastyNCT03016299
The Histological Effect of Various Microfracture Techniques on Human Chondral & Sub-chondral Tissue - an Ex-Vivo Study
An observational study of Partial or Total Hip Arthroplasty and Ex-vivo Preparat of Femoral Head, run by Meir Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Partial or Total Hip Arthroplasty, Ex-vivo Preparat of Femoral Head
- What is being tested?
- microfracture techniques
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all Adults who went through partial or complete replacement of the hip in our institute
Who may be able to join
- 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.
Who cannot join
- 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'
About this study
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.
Read more
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.
Read the 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.
- Being tested
- microfracture techniques
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microfracture techniquesProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Osteoarthritis hip joint | specimen of head of femur will be used- after total hip arthroplasty (due to Degenerative Osteoarthritis hip joint ) Receives: Procedure: microfracture techniques | |
| Non-Osteoarthritis hip joint | specimen of head of femur will be used- after Hip Hemiarthroplasty -Partial replacment (due to traumatic fracture) Receives: Procedure: microfracture techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
histological damage
microscopically assesing the histological damage to Human chondral \& Subchondral tissue in 3 common microfractures techniques ( morphological description)
Measured: withing 48 Hours after specimen fixation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionJun 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Partial or Total Hip ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03016299
- Sponsor's protocol ID
- 0167-16-MMC
- Status last verified
- Nov 2016
- First submitted
- 16 Nov 2016
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 27175466Augustin 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.
PubMed 22290154Chen 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. Epub 2011 Feb 24.
PubMed 21671261Chen 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.
PubMed 19402150Eriksson 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. doi: 10.1016/0022-3913(83)90174-9. No abstract available.
PubMed 6576145Hayashi 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. Epub 2009 Feb 13.
PubMed 19214692Menche 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. doi: 10.1016/s0749-8063(96)90059-6.
PubMed 8783821Mohlhenrich SC, Abouridouane M, Heussen N, Holzle 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. Epub 2016 Jun 11.
PubMed 27297835Orth P, Goebel L, Wolfram U, Ong MF, Graber 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. Epub 2012 Jan 5.
PubMed 22223716Singh 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;62:355-365. doi: 10.1016/j.jmbbm.2016.05.015. Epub 2016 May 16.
PubMed 27254280
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Histological Effect of Various Microfracture Techniques on Human Chondral & Sub-chondral Tissue - an Ex-Vivo Study
- ClinicalTrials.gov ID
- NCT03016299
- Acronym / sponsor ID
- 0167-16-MMC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 10 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteoarthritis hip joint | – | Procedure: microfracture techniquesspecimen of head of femur will be used- after total hip arthroplasty (due to Degenerative Osteoarthritis hip joint ) |
| Non-Osteoarthritis hip joint | – | Procedure: microfracture techniquesspecimen of head of femur will be used- after Hip Hemiarthroplasty -Partial replacment (due to traumatic fracture) |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all Adults who went through partial or complete replacement of the hip in our institute
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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'
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| microfracture techniquesDrill 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. | Procedure or surgery | Non-Osteoarthritis hip joint, Osteoarthritis hip joint |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
- Background: PubMed 27175466Alam 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.
- Background: PubMed 22290154Augustin 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.
- Background: PubMed 21671261Chen 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. Epub 2011 Feb 24.
- Background: PubMed 19402150Chen 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.
- Background: PubMed 6576145Eriksson 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. doi: 10.1016/0022-3913(83)90174-9. No abstract available.
- Background: PubMed 19214692Hayashi 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. Epub 2009 Feb 13.
- Background: PubMed 8783821Menche 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. doi: 10.1016/s0749-8063(96)90059-6.
- Background: PubMed 27297835Mohlhenrich SC, Abouridouane M, Heussen N, Holzle 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. Epub 2016 Jun 11.
- Background: PubMed 22223716Orth P, Goebel L, Wolfram U, Ong MF, Graber 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. Epub 2012 Jan 5.
- Background: PubMed 27254280Singh 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;62:355-365. doi: 10.1016/j.jmbbm.2016.05.015. Epub 2016 May 16.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Partial or Total Hip Arthroplasty and Ex-vivo Preparat of Femoral Head, run by Meir Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
histological damage (time frame: withing 48 Hours after specimen fixation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03016299, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2017; AzTrials last refreshed its copy on 1 Nov 2026.