This study focuses on the evaluation of Bonalive in bone defect healing and osteomyelitis treatment and it aims to investigate the bone healing capacity of BonAlive bioactive glass in patients who underwent debridement surgery in osteomyelitis…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
- Bone disorders (excl congenital and fractures)
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
First objective of this study is assessment of bone healing capacity of
Bonalive bioactive glass by High Resolution peripheral Quantitative Computed
Tomography (HRpQCT). Several bone parameters will be calculated during
longitudinal follow up (see section 5.1).
Secondary outcome
Second objective of this study is the evaluation of bone strength based upon
micro-finite element analysis (µFEA), calculated after HR-pQCT imaging. Bone
strength will be evaluated using longitudinal µFEA outcomes of patients during
follow up.
Third objective of this study is to assess the improvement of patient related
outcomes assessed at 6, 52 and 104 weeks after surgery. This is an addition to
the patient satisfaction obtained in standard follow-up algorithm of chronic
osteomyelitis treatment.
Fourth objective of this study is to evaluate the infection eradication success
of osteomyelitic bone defects reconstructed with BonAlive bioactive glass. This
is an important outcome because the presence of an infection may influence the
results of the HRpQCT scans, which makes these results no longer reliable.
Absence of infection will be based upon clinical data, X-ray analysis and
infection rates assessed in blood sample analysis, which belong to the standard
follow-up algorithm of chronic osteomyelitis treatment.
Background summary
Osteomyelitis is the inflammatory process of bone combined with bone
destruction generally caused by bacteria. These bony infections can be
localized solely in bone, but they can also involve environmental tissues such
as the bone marrow, periosteum and soft tissues. Osteomyelitis is commonly
caused by a local spread of contiguous infections i.e. trauma or joint
replacement, secondary to vascular insufficiency in patients with diabetes or
due to a less common haematogenous spread of bacteria. Pathogenic
micro-organisms causing these osteomyelitic infections are usually the
Staphylococcus aureus bacteria, which can lead to acute or chronic
osteomyelitis. Acute osteomyelitis usually develops and reduces in several days
or weeks and can become chronic osteomyelitis, which is a long-lasting
infection that can last for several months to even years.
Treatment of acute osteomyelitis with adequate systemic single-agent
antibiotics is usually sufficient, where the treatment algorithm of chronic
osteomyelitis generally consists of surgical debridement of the affected tissue
and administration of local and systemic antibiotics. Debridement surgery and
local antibiotic therapy are necessary because patients with chronic
osteomyelitis have infected dead bone combined with poor local vascularisation,
which lead to eradication difficulties when treated with solely systemic
antibiotics (6). Regarding the local administration of anti-bacterial bone
graft substitutes, such as antibiotic-loaded calcium sulphates or bioactive
glasses, major developments are seen in the last few years.
A promising biomaterial used in the application of local eradication of
infection is BonAlive bioactive glass (9, 10), Thereby BonAlive bioactive glass
has excellent bone filling capacities for bone defects existing after
debridement surgery. BonAlive is a S53P4 bioactive glass consisting of 53%
SiO2, 4% P2O5, 23% Na2O and 20% CaO produced by BonAlive Biomaterials Ltd in
Finland. Due to this composition BonAlive is biodegradable, stimulates bone
formation and has antibacterial effects that should lead to eradication of
infection and bone healing when combined with debridement surgery in the
treatment of chronic osteomyelitis.
Despite the fact that several studies stated good bone healing over several
years after implantation of BonAlive bioactive glass, these conclusions were
only established using the conventional radiology techniques. These studies
assessed degradation of BonAlive based on a subjective estimation of the
visibility of BonAlive particles on plain radiographic images. Imaging
techniques such as plain radiographic imaging and computed tomography (CT) are
not suitable for a reliable measurement of bony fusion of the implanted
biomaterials because a lack of objective parameters related to bone growth or
biomaterial degradation. To establish this bony fusion, high-resolution imaging
should be advantageous, which can be performed using the High Resolution
peripheral Quantitative Computed Tomography (HR-pQCT) imaging. HR-pQCT is an
imaging technique based on the possibility of providing 3-dimensional images
using computed tomography of the peripheral bone structures. Due to this high
resolution we can assess bone density and bone architecture like trabecular and
cortical bone structures up to a resolution of 82 µm. Thereby, using HR-pQCT
enables the possibility to calculate some biomedical properties of bones, such
as bone strength, using micro-finite element analysis (µFEA). The advantages of
imaging with HR-pQCT compared to conventional imaging techniques can enable the
possibility to analyse bone healing and the progression of bone healing in time
in patients treated with BonAlive.
Study objective
This study focuses on the evaluation of Bonalive in bone defect healing and
osteomyelitis treatment and it aims to investigate the bone healing capacity of
BonAlive bioactive glass in patients who underwent debridement surgery in
osteomyelitis treatment. This bone healing will be assessed using (HRpQCT) at
2, 6,12, 26, 52 and 104 weeks postoperative. In order to investigate the bone
healing capacity specific parameters will be analysed. Furthermore in order to
assess the longitudinal evolution of bone density trabecular bone and cortical
bone density will be compared over time based on HRpQCT images which will also
be used to assess the bone architecture over time the bone volume density, the
number of trabeculae and trabecular thickness will be analyzed. Osteomyelitis
treatment ie eradication of infection will be measured by comparing the
infection parameters( CRP and ESR) in blood samples pre-operatively and during
follow.Thereby we will also evaluate outcomes as pain, patient satisfaction and
quality of life using te evaluation of different questionnaires during follow
up.
Study design
Prospective longitudinal outcome study.
In this prospective longitudinal observational outcome study the clinical
application of BonAlive bioactive glass for attaining bone healing, in patients
with osteomyelitic bone defects due to debridement surgery, will be assessed.
We will include patients who underwent debridement surgery combined with
BonAlive implantation in a previous experimental study in order to assess the
longitudinal results of the bone healing capacities until a maximum of
24-months after surgery. Assessment of bone healing capacities will be studied
using HR-pQCT imaging techniques, where high-resolution imaging enables us to
evaluate the micro-architecture and strength of bone several times during
follow-up. All patients will undergo six HR-pQCT scans at 2, 12, 26, 52 and 104
weeks after surgery. Eradication of infection will be assessed by taking
bloodsamples for analysis of the infectious parameters CRP and ESR previous to
surgery and at 2, 6, 52 and 104 weeks after surgery leucocytes count direct
postoperative and after 6-52-104 weeks. Clinical outcomes about pain, function
and satisfaction will be assessed by using VAS-scores, SF-36 questionnaires and
EQ-5D questionnaires at 6, 52 and 104 weeks post-operative and will be compared
to pre-operative questionnaires. During this study we aim to include at least
20 patients.
Intervention
not applicable
Study burden and risks
After surgery the patient must return six times for outpatient monitoring. This
is 2x more than the average patient in the regular treatment control would
visit the hospital. During these checks, the patient receives several studies,
such as blood tests, x-rays and HRpQCT scans. Also, he / she will occasionally
have to fill out questionnaires. The burden and duration of these studies
varies for the single patient. The duration of these various studies is: HRpQCT
Scart 30 minutes, questionnaires (prior to be sent to the patient) to fill 15
minutes, consult orthopedic surgeon 15 minutes, X-rays 15 minutes, blood
samples 15 minutes. The visits to the hospital take a minimum of 45 minutes and
a maximum of 75 minutes.Thereby it will take some time to travel to the
hospital. Participation in this study provides an (relatively small) additional
burden for the patient, but simultaneously the patient is monitored better.
All patients participating in this study are at risk for risks associated with
the operation. These patients will undergo a surgical debridement and bone
reconstruction with BonAlive bioactive glass in combination with adjuvant
treatment with antibiotics to treat osteomyelitis. The potential risks for
these osteomyelitis treatment include: bleeding (with possibly a blood
transfusion as a result), post-operative wound problems, post-operative pain,
fractures of the bone lesions, neurological damage, persistent wound leak and
persistent or recurrent infection. However, the potential benefits from
osteomyelitis surgery are bigger (in general) than the risks of surgery and
monitoring.
P.Debeyelaan 25
Maastricht 6229 HX
NL
P.Debeyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
Patients eligible for inclusion in this study are scheduled to undergo osteomyelitis debridement surgery combined with implantation of BonAlive bioactive glass at MUMC+. ;Inclusion criteria:
Subjects meeting all of the following criteria will be included in the study.;1. Patients with chronic (>12 weeks) osteomyelitis located in the distal tibia, distal fibula, ankle or foot. Or located in de distal radius, distal ulna, wrist or hand.
2. Patients who are scheduled to undergo osteomyelitis debridement surgery combined with implantation of BonAlive bioactive glass at MUMC+.
3. Patients that have normal contralateral bone, which will be used as an internal control.
4. Patients who accepted and signed the ethics committee approved informed consent before the first HR-pQCT scan.
5. Male and non-pregnant female patients between 18-70 years of age.
6. Patients who are physically and mentally able and willing to comply with the regulations of this study.
7. Patient can read and understand the Dutch language.
Exclusion criteria
Subjects meeting any of the following criteria will be excluded from the study.;1. Patients who are unwilling to cooperate with the study protocol and follow-up schedule.
2. Patients with chronic osteomyelitis associated with fracture in need of osteosynthesis surgery
3. Patients who, as judged by the surgeon, are mentally incompetent or are likely to be non-compliant with the prescribed post-operative routine and follow-up evaluation schedule.
4. Obese patients where obesity is severe enough to affect subject*s ability to perform activities of daily living (body mass index, kg/m2 > 40)
5. Patients with malignancy - active malignancy within last 1 year
6. Patients known with a diagnosed systemic disease that would affect the subject*s welfare or overall outcome of the study (severe osteoporosis requiring medication, Paget*s disease, renal osteodystrophy, hypercalcaemia) or is immunologically suppressed, or receiving steroids in excess of physiologic dose.
7. Patients with systemic or metabolic disorders leading to progressive bone deterioration.
8. Has received drugs that may interfere with bone metabolism within two weeks prior to the planned surgery date (e.g., steroids or methotrexate) excluding routine perioperative, non-steroidal anti-inflammatory drugs.
9. Patients with a known sensitivity to, specific antibiotics or radiation.
10. Patients under age of 18 and above age of 70
11. Females who wish to become pregnant before, during or after (up to two years) the course of their treatment.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL56189.068.16 |