Treatment Trials

14 Clinical Trials for Various Conditions

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RECRUITING
A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee
Description

The objective of this study is to compare the efficacy and safety of MACI® vs arthroscopic microfracture in the treatment of patients aged 10 to 17 years with symptomatic articular chondral or osteochondral defects of the knee.

COMPLETED
Post-Operative Rehabilitation of Knee Osteochondral Defect: A Case Series
Description

A case-series review was performed on five collegiate athletes with osteochondral lesions of the knee at California State University, Northridge (CSUN). All subjects received surgical intervention to treat the defect. The surgeries performed were either an Osteoarticular Transfer System (OATS) procedure and/or a Microfracturing procedure. Subjects were treated post-operatively by the CSUN team physical therapist and/or athletic trainers at CSUN. This paper seeks to provide information about osteochondral defects of the knee, the surgical interventions, and a protocol for post-operative treatment and rehabilitation of such injuries.

WITHDRAWN
Long Term Outcomes of Osteochondral Allografts for Osteochondral Defects of the Knee
Description

The purpose of this study is to evaluate the functional and clinical outcomes of patients receiving femoral condyle osteochondral allografts, to evaluate potential predisposing factors to failure of such grafts, and to compare the overall outcomes of the grafts to the current standard of care for smaller lesions, microfracture. Our hypothesis is that patients treated with these allografts will demonstrate significant functional improvement as measured by validated outcome scoring measures and their function will be at least equal to that of microfracture outcomes.

TERMINATED
Evaluation of a Composite Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Knee Osteochondral Defects
Description

The objective of this study is to determine how effective a plug made out of human bone (called "CR-Plug") will be in the treatment of smaller, focal defects (like the injury the patient has to their knee).

Conditions
RECRUITING
Evaluating Cryopreserved Osteochondral Allograft Cores for the Treatment of Osteochondral Lesions in the Knee
Description

The primary objective of this study is to obtain evidence of the effectiveness of Cryopreserved Osteochondral Allograft Core in the treatment of osteochondral lesions on the femoral condyle.

COMPLETED
Agili-C™ Implant Performance Evaluation
Description

The current study compares the efficacy and safety of the Agili-C implant to Surgical Standard of Care treatment in patients suffering from joint surface lesions of the knee. The patient population is heterogeneous, involving different kinds of joint surface lesions: focal cartilage lesions, osteochondral defects and mild to moderate osteoarthritis, including multiple defects.

TERMINATED
ReNu™ Marrow Stimulation Augmentation
Description

To evaluate the use of ReNu™ allograft for the augmentation of marrow stimulation for osteochondral lesions

ENROLLING_BY_INVITATION
Clinical Registry Assessment of the Missouri Osteochondral Allograft Preservation System - MOPS
Description

With institutional review board approval and informed consent, patients are prospectively enrolled into a registry to follow outcomes after osteochondral allograft (OCA) and/or meniscal allograft transplantation. Patients are included when 1 year followup data are available, including complications and reoperations, patient reported outcome measures (PROMs), compliance with rehabilitation, revisions, and failures. In addition, MOPS grafts are compared to standard preservation grafts, and unipolar, multisurface, and bipolar cohorts, as well as patient compliance variables, are compared.

RECRUITING
BioPoly® Partial Resurfacing Knee Implant IDE
Description

The goal of this randomized controlled clinical trial is to demonstrate the safety and effectiveness of the BioPoly® Partial Resurfacing Knee Implant for the treatment of cartilage defects of the distal femur in adult patients with knee pain and symptoms who are candidates for surgical intervention of the knee compared to outcomes for the control group. The primary effectiveness endpoint is Month 24 composite clinical success (CCS) defined by: * no secondary surgical intervention (SSI) and * an improvement from baseline in the Knee injury and Osteoarthritis Outcome Score (KOOS) total score (scaled 0 to 100) of at least 10 points. Researchers will compare the CCS for the investigational device group to a control group receiving the standard of care, either microfracture or debridement). Subjects randomized to the investigational group will receive the BioPoly Knee device and those randomized to the control group will receive the current standard of care, either microfracture or debridement.

ENROLLING_BY_INVITATION
Prospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement (PROCLAIM)
Description

This is a Humanitarian Device Exemption (HDE) approved device. The purpose of this study is to evaluate the continued safety and probable benefit of the restor3d Total Talus Replacement device in commercial use.

TERMINATED
Evaluation of the CR Plug (Allograft) for the Treatment of a Cartilage Injury in the Knee.
Description

Determine the ability of the allograft plug for the treatment of a cartilage injury in the knee

Conditions
UNKNOWN
Pivotal Study to Evaluate the Safety and Efficacy of GelrinC for Treatment of Cartilage Defects
Description

Multicenter, open-label, controlled, non-randomized, double arm trial with a prospective treatment arm (GelrinC). This study compares the efficacy and safety of GelrinC to a historical control arm (microfracture) in the treatment of cartilage defects in the knee.

TERMINATED
Chondrofix Osteochondral Allograft Prospective Study
Description

The overall study objective is to evaluate Chondrofix Osteochondral Allograft ("Chondrofix") for the repair of osteochondral lesions in the knee. This includes, but is not limited to primary cartilage lesion repair and revision of failed prior cartilage repair treatments. The study hypothesis is that Chondrofix Allograft will provide pain relief and functional improvement as demonstrated by a comparative analysis of baseline clinical evaluations at 24 months of follow-up.

UNKNOWN
DeNovo NT Ankle LDC Study
Description

The purpose of this post-market clinical study is to collect long-term outcomes for DeNovo NT Graft treatment of articular cartilage lesions in the ankle in a standard clinical setting. Outcomes to be assessed include pain, function, activity levels and healthcare resource use.