A first in human study with a safety analysis and an evaluation of early performance in terms of the clinical outcomes after implantation of the 3D-Shelf implant in patients with adult hip dysplasia, to show that the 3D-Shelf procedure is safe, has…
ID
Source
Brief title
Condition
- Congenital and hereditary disorders NEC
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study objectives are an evaluation of the safety, feasibility and
the performance after implantation of the 3D-Shelf implant.
The safety will be evaluated by incidence, nature, and severity of procedure-
and/or device-related adverse events up to 12 months post-surgery, with an
interim analysis 6 months after the first 5 patients have undergone surgery.
The clinical performance will be evaluated by describing the change from
baseline in widely used questionnaires for the evaluation of osteoarthritis
and/or hip surgeries, which cover aspects such as pain, range of motion (ROM),
functioning in activities of daily life (ADL), gait, and quality of life.
Secondary outcome
The placement of the implant will be evaluated based on the accurate
positioning of the implant and the technical feasibility of the surgery.
Difficulties or deviations from the surgical protocol will be described. The
implant positioning will be assessed by comparing the post-operative CT-scan to
the pre-operative CT-scan and the planning of the implant.
To analyse potential predisposing risk factors for an unsuccessful outcome, the
clinical outcomes of the implantation of the 3D-Shelf will be correlated with
possible predisposing factors.
Background summary
Hip dysplasia is a common orthopedic condition, defined as a abnormality in the
shape, size and orientation of the femoral head, acetabulum or both. The most
frequent presentation of hip dysplasia is the maldevelopment of the acetabulum,
resulting in insufficient superior coverage of the femoral head, defined as a
lateral center-edge angle (Wiberg) of less than 20 degrees. Patients suffer
from groin pain, an abnormal gait, decreased strength, and increased rate of
degenerative hip disease.
The possible treatments affecting the shape of the acetabulum once the patient
reaches adolescence, are all surgical. The PAO is regarded as the current gold
standard in treatment of symptomatic adult hip dysplasia. The 3 dimensional
orientation of the acetabulum is changed with the use of 3 osteotomies around
the acetabulum and a refixation in the obtained position. However, the PAO is a
difficult operation and is associated with a large number of major
complications (up to 37%) and the surgery is associated with a long
rehabilitation period.
Hence, a strong unmet need exists for an effective but less invasive solution
that enhances the quality of life of the adult hip dysplasia patients. The
treatment gap can be filled with a 3-dimensional (3D) shelf procedure (as
mentioned by Willemsen et al). This custom made implant (called 3D-Shelf
implant) was developed with the goal to be more predictable in terms of
containment and fit than the old autologous shelf-acetabuloplasty, and less
invasive and easier to perform than the PAO.
Study objective
A first in human study with a safety analysis and an evaluation of early
performance in terms of the clinical outcomes after implantation of the
3D-Shelf implant in patients with adult hip dysplasia, to show that the
3D-Shelf procedure is safe, has lower complication rates and shows no
inferiority in clinical-outcome compared to the current treatment of a
peri-acetabular osteotomy.
Study design
Single centre, prospective, open-label, clinical investigation involving a new
medical implant device, that will be performed at the Anna hospital in Geldrop.
The study aims to assess the clinical outcomes and safety of the first in-human
implantation of the 3D-Shelf implant.
Refer to the study protocol on pages 23-25 for a detailed description of the
methodology.
Intervention
Prior to the surgery the patients will need a CT scan and a MRI scan to design
the patient specific implant. The patients will be admitted to the hospital for
implantation of the 3D-Shelf, and will stay for at least one night after
surgery. For the first 6 weeks after surgery the patients will be limited to
partial loadbearing on the treated hip, using crutches.
Study burden and risks
Replasia BV performed risk analysis in accordance with EN ISO 14971:2019.
Careful definitions of specific eligibility criteria, study procedures and
instructions for use, appropriate selection, qualification and training of the
investigators, and patient follow-up procedures have been designed as to
further contribute to reduce risks as far as possible for the patient and
residual risk acceptance. For this study the residual risks have been
controlled to levels as low as possible.
For the purpose of risk control and mitigation during the conduct of the study
the clinical investigation will be split into 2 phases:
• The Safety phase of the clinical investigation will enrol a small cohort of
subjects within which the initial safety of the 3D-Shelf implant will be
evaluated at an interim analysis at 6 months post surgery by the DSMB. A
maximum of 5 subjects will be treated. A formal review of safety will be
undertaken when all patients reach 12 months post-surgery.
• The Performance phase of the clinical investigation will enrol subjects until
a total of 10 subjects have been treated with the investigational device.
Furthermore, potential risks associated with participation in this
investigation will be minimized and managed in accordance with ISO 14155, and
requirements of the approving Ethics Committee(s).
Interleuvenlaan 64
Heverlee 3001
NL
Interleuvenlaan 64
Heverlee 3001
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
• Hip dysplasia based on AP x-ray with a LCEA of <25°
• Groin pain and/or gait abnormalities, with no other explanatory hip pathology
• Aged at least 18 years and maximal 45 years at time of surgery (indicated age
for PAO(19))
• Willing to comply with the study visit schedule during 12 month follow-up
• Able and willing to provide informed consent
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• Previous acetabular surgery >10yr of age
• Signs of osteoarthritis on x-ray (Tonnis classification >1),
• Body mass index of more than 35
• Large labral tears visible on non-contrast MRI
• Pre-consultation known titanium allergy
• Pre-consultation known medical histories of diseases that per the
investigator possibly affect the outcome: neuromuscular disease affecting the
stability of the hip, diseases affecting bone ingrowth and fixation strength of
the implant like rheumatoid arthritis and metabolic bone diseases, e.g.
osteomalacie, osteoporosis, hyperparathyroidism, hypercalcemia.
• Pre-consultation known pregnant women or women who are planning to become
pregnant during the duration of the study.
• Part of vulnerable population (e.g. Mentally disabled with cognitive
impairment or mental disease)
• Currently participating in another investigational clinical trial.
• Unable to provide informed consent (e.g. insufficient language skills)
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| CCMO | NL80265.000.24 |