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New treatment option for Osteoarthritis, Hip
Official title Early Feasibility Study of Cartilage Defect Repair
ClinicalTrials.gov ID: NCT06823089
What this study is testing
- What it's testing
- Any patient aged 14 or older up to 64 years of age with hip disease, resulting in loss of articular cartilage integrity on the femoral head (e.g., femoroacetabular impingement or other structural deformity), has failed conservative care, and is a candidate for surgical intervention to treat.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 64
You may be able to join if
- At least 14 years of age to no older than 64 years of age people 14-21 years of age must have radiographic evidence of epiphyseal closure in the hip...
- BMI \< 35
- Failed at least 6 weeks of conservative treatment (e.g., anti-inflammatory pain medications, physical therapy, injections)
- Duration of symptoms consistent with intra-articular disease (i.e., groin, lateral and/or posterior hip pain) that have persisted for at least 3...
- Loss of articular cartilage integrity (\~1 - 6 cm\^2 in area) on the femoral head (confirmed by MRI), without an opposing lesion, that can be treated...
You likely can't join if
- Current users of nicotine in any form (e.g., cigarettes, e- cigarettes/vaping, chewing tobacco, nicotine patches, gum, lozenges), or individuals who...
- Type 1 or Type 2 Diabetes
- Systemic steroid use in the 3 months prior to screening
- Coxa plana, coxa magna, or proximal femoral focal deficiency on the femoral head that would result in implant mismatch of the femoral head contour
- Any acute or chronic condition that would limit the ability of the patient to participate in the study (e.g., COPD, congestive heart failure),
- Bleeding disorders
See the full eligibility criteria
Who can join
- At least 14 years of age to no older than 64 years of age people 14-21 years of age must have radiographic evidence of epiphyseal closure in the hip joint
- BMI \< 35
- Failed at least 6 weeks of conservative treatment (e.g., anti-inflammatory pain medications, physical therapy, injections)
- Duration of symptoms consistent with intra-articular disease (i.e., groin, lateral and/or posterior hip pain) that have persisted for at least 3 months)
- Loss of articular cartilage integrity (\~1 - 6 cm\^2 in area) on the femoral head (confirmed by MRI), without an opposing lesion, that can be treated with a single ReNew Hip Implant
- Radiographic assessment with joint space width \> 2 mm (verified by x-ray)
- Meets an acceptable preoperative medical clearance and is free of conditions that would pose excessive operative risk, in the opinion of the investigator
- Given consent to participate in the study
- Able to understand the purpose of the study, his/her role, and is available for follow-up for the duration of the study:
- Subject has signed an IRB (Institutional Review Board) approved Informed Consent Form agreeing to participate in the extension study after the nature, scope, and possible consequences of the study have been explained in...
- Subject is able to fully understand the purpose of the study, his/her role as a participant in the study, and plans to be available through five years post-operative follow-up
What rules you out
- Current users of nicotine in any form (e.g., cigarettes, e- cigarettes/vaping, chewing tobacco, nicotine patches, gum, lozenges), or individuals who have discontinued nicotine use less than 30 days prior to screening.
- Type 1 or Type 2 Diabetes
- Systemic steroid use in the 3 months prior to screening
- Coxa plana, coxa magna, or proximal femoral focal deficiency on the femoral head that would result in implant mismatch of the femoral head contour
- Any acute or chronic condition that would limit the ability of the patient to participate in the study (e.g., COPD, congestive heart failure),
- Bleeding disorders
- Current cancer (with the exception of non-melanoma skin cancer)
- Pregnancy or planning to become pregnant during the study period
- Active infection or sepsis
- History of local hip infection
- Known metastatic or neoplastic disease
- Conditions that may interfere with implant survival or outcomes (e.g., severe dysplasia)
- Life expectancy less than 2 years
- Intra-articular therapy within 3 months of enrollment
- Inadequate bone stock (as determined by SCORE or MORES assessment) to support the device
- Femoral head is:
- outside of the 46 - 56 mm range in either anteroposterior diameter or lateral diameters or
- an aspherical head deformity that results in contour mismatch of 16a
- Moderate to severe renal insufficiency
- Emotional or neurological condition that would preempt ability or willingness to participate in the study
- Above the knee amputation of the contralateral or ipsilateral leg
- Known allergies to the components of the device (polycaprolactone)
- Is a prisoner
The study team makes the final eligibility decision.
Where it's taking place
- St Louis, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St Louis, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.