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NCT ID: NCT01285011 Completed - Hammer Toe Clinical Trials

Short Term Follow-up of Patient Implanted With the Proximal Interphalangeal Implant

Start date: April 2009
Phase: N/A
Study type: Observational

Hammertoe and ClawToe are ones of the most common foot deformities. The second toe is the most frequently affected, but the other small toes may also be involved. When nonoperative treatment fails, surgery often is recommended. One surgical option is the arthrodesis of the Proximal Interphalangeal (PIP) joint. This arthrodesis is technically demanding, its needs: - Internal fixation; - Interphalangeal Compression; - Anatomic PIP joint plantar flexion angle. The implant Ipp-On has been developed for this specific arthrodesis. The objective of this study is to evaluate the efficacy and safety of the Proximal Interphalangeal Implant: Ipp-On at short term follow up. The safety of the Ipp-On will be described in terms of rate of device related complications. The efficacy of the Ipp-On will be described in terms of fusion rate at 6 months.

NCT ID: NCT01283438 Active, not recruiting - Clinical trials for Lumbar Disc Herniation

A Prospective, Randomized, Multicenter Study to Demonstrate the Superiority of the Barricaid to Discectomy for Primary Lumbar Disc Herniation

Start date: December 17, 2010
Phase: Phase 4
Study type: Interventional

A randomized study to demonstrate the superiority of the Barricaid® when used in conjunction with limited discectomy, compared to limited discectomy alone, with regard to preventing reherniation and the recurrence of pain or dysfunction.

NCT ID: NCT01282645 Withdrawn - Craniotomy Clinical Trials

Case Series to Evaluate Patient Specific Implants (PSI) in Polyether Ether Ketone (PEEK) Performance After 2 Years

Start date: July 2011
Phase: N/A
Study type: Observational

The primary objective of this retrospective study is to evaluate the percentage of patients with device related adverse events (infection, rejection, dislocation, fracture of the implant) in the first 24 months after implantation.

NCT ID: NCT01282034 Completed - Clinical trials for Knee Osteochondral Lesion

Study for the Treatment of Knee Chondral and Osteochondral Lesions

Start date: January 2011
Phase: Phase 4
Study type: Interventional

INTRODUCTION Marrow stimulation techniques as subchondral drilling or microfractures represent ones of the most frequently used methods for chondral and osteochodral defects repair and considered as standard techniques. MaioRegen® (Fin-Ceramica Faenza S.p.A., Italy) is a bioceramic, multi-layered scaffold, in a single gradient structure, consisting of deantigenated Type I equine collagen and Magnesium enriched-Hydroxyapatite, able to mime the entire osteocartilaginous section. MaioRegen® is able to promote the tissue regeneration in case of severe and large chondral/osteochondral lesions, otherwise difficult to treat, as previously demonstrated in vitro, in vivo and in a clinical study. OBJECTIVES The present study proposes to compare MaioRegen® performances with respect to reference standard surgical techniques (microfractures and subchondral drilling) for the treatment of chondral/osteochondral lesions, in order to consolidate MaioRegen®, as innovative surgical approach. STUDY DESIGN The clinical trial is multicenter, prospective, randomized, controlled, two-arm, single-blind and involves eleven European centres and 150 patients. Eligible subjects will be randomly allocated to one of the two treatment groups: control group, treated with marrow stimulation techniques, and treatment group, treated with MaioRegen® implant. Patient defect will be evaluated pre-operatively and each patient enrolled must meet all the entry criteria for the trial. Before enrolment, each subject should declare his voluntary participation to the study by informed consent signature. Arthroscopic control will be carried out immediately before the randomization and thus surgical treatment, to confirm the characteristics of the lesion to be treated and finalizing the recruitment. For each patient 6, 12 and 24 months post-operative follow-up visits will be carried out and during each follow-up visit the Case Report Form (CRF) will be filled in the specific section. Within the CRF, at each follow-up section, commonly used and specific scores will be assigned for the established end-points (IKDC, KOOS, Tegner Score, VAS, MRI Mocart Scoring System). Patients selected will be randomized to undergo one of two study groups, as prescribed by the randomization list.

NCT ID: NCT01281527 Completed - Schizophrenia Clinical Trials

Paliperidone Palmitate Flexible Dosing in Schizophrenia

PALMFlexS
Start date: November 2010
Phase: Phase 3
Study type: Interventional

This study explores the tolerability, safety and efficacy (i.e. how well the drug works) of flexibly dosed paliperidone palmitate in the treatment of schizophrenia in patients previously unsuccessfully treated with other oral or long-acting injectable (LAI) (i.e. with a long duration of action) antipsychotics.

NCT ID: NCT01281254 Terminated - Ovarian Cancer Clinical Trials

AMG 386 (Trebananib) in Ovarian Cancer (TRINOVA-2)

Start date: April 18, 2011
Phase: Phase 3
Study type: Interventional

To determine if AMG 386 plus pegylated liposomal doxorubicin (PLD) is superior to placebo plus PLD as measured by progression-free survival (PFS) The hypothesis for this study is that AMG 386 plus PLD will prolong PFS compared to placebo plus PLD in women with recurrent partially platinum sensitive or resistant epithelial ovarian, primary peritoneal or fallopian tube cancer.

NCT ID: NCT01281085 Completed - Shoulder Pain Clinical Trials

Validation of a Score for Shoulder Function Evaluation Based on Movement Analysis

Start date: October 2010
Phase: N/A
Study type: Observational

Questionnaires are frequently used to evaluate shoulder function in various diseases or after surgery. However, measurement of shoulder function is presently a controversial issue. Shoulder movement analysis based on embedded sensors could be a promising alternative to questionnaires. Some studies already demonstrated the relevance of this approach. It has also been demonstrated that a simple testing procedure including only two arm movements produces comparable results to more complicated testing procedures. However, more studies are needed to extensively establish if this simplified testing procedure provides a trustworthy evaluation of patient shoulder function and its evolution. This study is a preliminary study which aims to develop a precise testing procedure which will be used in a future study aiming to evaluate measurement properties of a simple shoulder function test based on movement sensors.

NCT ID: NCT01280370 Completed - Clinical trials for Incisional Hernia Repair

Prospective Evaluation of Laparoscopic and Open Incisional Hernia Repair: a Multicenter Cohort Study

IHR_SALTC
Start date: September 2010
Phase:
Study type: Observational

Nowadays incisional hernia are primarily repaired using prosthetic meshes. In Switzerland such meshes are mainly implanted via open or laparoscopic approach. The differential impact of these two types of surgical technique on recurrence rate will be investigated with this study. With this multicenter cohort study the outcomes of laparoscopic and open incisional hernia repair will be investigated prospectively. Hernia recurrence is the main outcome measure. Hypothesis: Laparoscopic incisional hernia repair is associated with a lower recurrence rate compared to open incisional hernia repair.

NCT ID: NCT01280175 Completed - Healthy Volunteers Clinical Trials

Foster With or Without Charcoal Block or Aerochamber Plus

Start date: December 2006
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the systemic exposure of BDP, its metabolite beclomethasone 17-monopropionate (B17MP) and formoterol after inhalation of BDP/Formoterol 100/6 µg pMDI combination (CHF1535) using the standard actuator and charcoal block technique or using a Spacer (AeroChamber Plus, Trudell) in comparison with inhalation using the standard actuator

NCT ID: NCT01278732 Completed - Clinical trials for Suspected Arterial Hypertension

Central Blood Pressure Over 24 Hours (ABPM) and Left Ventricular Mass

Start date: January 2011
Phase: N/A
Study type: Observational

The investigators aim to investigate whether central systolic blood pressure, as measured during regular 24 hour ambulatory blood pressure monitoring (ABPM), is a better predictor of left ventricular mass than peripheral systolic blood pressure during ABPM.