| Eligibility |
Inclusion Criteria:
- Persons of childbearing potential must have a negative pregnancy test prior to
receiving the study drug and will agree to use adequate contraception (hormonal or
barrier method or abstinence) at the time of screening. Females of childbearing
potential are defined as premenopausal and not surgically sterilized, or
post-menopausal for fewer than 2 years. A urine pregnancy test will be performed prior
to the administration of the study drug to confirm negative results. If the urine
pregnancy test is positive, the study drug will not be administered, and the result
will be confirmed by a serum pregnancy test. Urine pregnancy tests will be performed
by qualified personnel using kit. Persons becoming pregnant during the study will
continue to be monitored for the duration of the study or completion of the pregnancy,
whichever is longer. Monitoring will include perinatal and neonatal outcome. Any SAEs
associated with pregnancy will be recorded.
- Chronic (> 3 months), unilaterally symptomatic, ICRS Grade III or IV cartilage lesions
ranging in size from 2 to 6 cm2. Patients with episodes of contralateral hip pain that
is asymptomatic at the time of enrollment will be eligible for inclusion. However,
patients with previous episodes of contralateral hip pain who experience a repeat
episode of contralateral pain similar to their established pattern of pain during the
course of the trial will not be considered as having experienced an adverse event.
- Radiographic hip OA of Tönnis Grade 1 or less, consisting of normal hip radiographs
(Grade 0) or doubtful narrowing of the joint space and possible osteophytic lipping
(Grade 1) as agreed upon by two study co-investigators without underlying structural
hip abnormalities
- Previous 6 week or longer trial of one of the following conservative treatments:
activity modification, weight loss, physical therapy, anti-inflammatory medications,
or injection therapy (e.g. cortisone). An adequate trial will consist of pursuance and
reasonable execution (i.e. > 80% medication or therapy compliance) of medically
reasonable course of non-operative modalities with minimal to no improvements in
symptoms
- If applicable, at least 3 months will have passed since the last target hip
intraarticular injection prior to undergoing the RECLAIM procedure and at least 6
months will have passed between any prior arthroscopic or open hip procedures.
- Able to routinely walk without assistance (e.g. cane, walker)
- Clinically stable target hip.
- No additional surgery planned in the target hip for at least 12 months following the
RECLAIM procedure
- Completed general physical and well-being evaluation with primary care provider within
12 months of enrollment
- Fully understanding of the requirements of the study and willingness to comply with
the treatment plan, including laboratory tests, diagnostic imaging, and follow-up
visits and assessments
- Can provide written informed consent and complete HIPAA documentation after the nature
of the study is fully explained and prior to any study-related procedure
Exclusion Criteria:
- Pregnant or nursing, or planning on becoming pregnant during the study period
- Congenital or acquired malformation of the target hip resulting in significant
deformity or leading to problems with the study treatment or analysis of the results
- Significant structural deformity, including large cam lesion (alpha angle greater than
55 degrees) or moderate dysplasia (defined as lateral center edge angle less than 18
degrees).
- Injections of any kind into the target hip within 3 months prior to study enrollment
- History of intra-articular infection in the target hip
- History of superficial infection in the target hip within 6 months of study
enrollment, or evidence of current superficial infection affecting the target hip
- History of falls requiring medical attention, or gait instability
- Clinically significant abnormal hematology (complete blood count with differential),
blood chemistry, or urinalysis screening laboratory results. Absolute cutoffs for
exclusion include hemoglobin < 11 g / dL, platelets < 110,000 platelets / mL, and an
INR greater than 1.3.
- Body mass index (BMI) > 35 kg/m2
- Tönnis Grade II or greater on X-Ray.
- Taking anticoagulant medications (e.g. warfarin, heparin or clopidogrel) which may
pose a clinically significant contraindication to the surgical RECLAIM procedure
- Taking herbal therapies or supplements within 4 weeks of enrollment or unwilling to
avoid use of herbal therapies or supplements until study completion (includes, but not
limited to chondroitin sulfate, diacerein, n-glucosamine, piascledine, and capsaicin)
- Taking non-steroidal anti-inflammatory medications (e.g. COX-2 inhibitors) without a
stable dosing regimen for at least 4 weeks before baseline evaluation, or anticipating
not remaining on a stable dose until study completion
- On chronic, immunosuppressive transplant therapy or having a chronic,
immunosuppressive state, including use of systemic steroids/corticosteroids
- Current tobacco product use, including nicotine patch or other nicotine products
- Clinically significant rheumatological or inflammatory disease of the hip or
chondrocalcinosis/calcium pyrophosphate disease (CPPD), hemochromatosis, inflammatory
arthritis, arthropathy of the hip associated with juxta-articular Paget's disease of
the femur or pelvis, ochronosis, hemophilic arthropathy, infectious arthritis,
Charcot's hip joint, villonodular synovitis, and synovial chondromatosis
- Ongoing infectious disease, including but not limited to tuberculosis, HIV, hepatitis,
and syphilis
- Clinically significant cardiovascular (e.g. history of myocardial infarction,
congestive heart failure or uncontrolled hypertension), neurologic (e.g. stroke, TIA)
renal, hepatic, orthopedic (e.g. surgery on other weight bearing joints that will
interfere with study, osteoporosis, acute lower body fractures), or endocrine disease
(e.g. diabetes).
- Any clinically significant comorbidity affecting the patient's ability to undergo
surgery
- Vascular or neurological disorder affecting the either lower limb which poses clinical
significance to the safety of the operative RECLAIM procedure.
- History of cancer/malignancy with the exception of adequately treated basal cell or
squamous cell carcinoma of the skin not associated with the target knee
- History of clinically significant blood dyscrasia, including but not limited to
anemia, thrombocytopenia, and monoclonal gammopathy
- Participation in a study of an experimental drug or medical device within 3 months of
study enrollment
- Known allergy to local anesthetics or other components of the study drug. This
includes known allergy or contraindications to products of bovine origin (including
aprotinin) or hypersensitivity to antibiotics, if the latter are used in the
manufacturing process
- Any contraindication to MRI scan according to MRI guidelines, or unwillingness to
undergo MRI procedures
- Any illness or condition which, in the investigators' judgement will interfere with
the patient's ability to comply with the protocol, compromise patient safety, or
interfere with the interpretation of the study results
- History of coagulopathy, including bleeding diathesis and deep venous
thrombosis/pulmonary embolism.
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