Clinical Trials Logo
  1. Home
  2. Knee Deformity
  3. NCT05241691

Retrospective Evaluation of GGPSP's Safety and Clinical Performance for the Treatment of Lower Limbs Deformities.

Joint Diseases Clinical Trial

Official title:
Retrospective Clinical Study for the Evaluation of the Safety and Clinical Performance of the Medical Device "Guided Growth Plate System Plus" (GGPSP) for the Treatment of Bone Deformities of the Lower Limbs in Skeletally Not Mature Children.

Clinical Trial Summary

Orthofix is conducting this retrospective Post-market clinical follow up (PMCF) study to assess the safety and clinical performance of the GGPSP device, which is a new version of the Guided Growth Plate System (GGPS) from which it differs for small modifications compared to the original design. The purpose of the study is to collect clinical evidence from the use of the device in a representative number of pediatric patients who have already been treated with the device in the study and with at least one control visit post removal of plaque.. For this purpose, a retrospective PMCF study was considered to be the most appropriate study design to obtain the necessary information.

Clinical Trial Description

GGPSP (also named 8 Plate Plus) has been developed to redirect long bone growth and is used to correct gradually angular deformity in growing children. The device is indicated for the treatment of specific conditions/pathologies between which: - deformity of the knee (femur and / or tibia) in varum/valgus or flexural extension; - deformity of the ankle in varum/valgus or plantar flexion; - femur and/or tibia length discrepancy. Objectives: The primary objective of the clinical investigation is to assess the safety of the 8 Plate Plus. The secondary objective of the clinical investigation is to assess the clinical benefit of the 8 Plate Plus. The Investigator will include in the study the patients who at the screening visit (Visit 0) will meet all the selection criteria. It is understood that, given the retrospective nature of the study and given that the consent of eligible patients has been collected in advance, the patient should not attend the screening visit or subsequent visits. In addition, during the screening visit (Visit 0) the Investigator will collect demographic data and patient history. Subsequently, the data of interest relating to the surgery for the application of the plate (Visit 1) and the period of treatment will be collected, or related to the 2 follow up visits (Visits 2 and 3) carried out until or at the removal of the plate/ plates (Visit 4). The course of treatment will be monitored as per clinical practice and will then be collected data that correspond to the follow-up visit planned on average 4 months after removal of the plate/plates (visit 5). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05241691
Study type Observational
Source Orthofix s.r.l.
Contact
Status Completed
Phase
Start date November 16, 2021
Completion date January 24, 2022
View Details
See also
  Status Clinical Trial Phase
Withdrawn NCT04976972 - A Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional Instrumentation N/A
Not yet recruiting NCT03726788 - Intra Articular Injection of Botulinum Toxin Versus Corticoids in Gonarthrosis Phase 2
Completed NCT02944448 - A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee Phase 2
Completed NCT02604446 - Depot-opioids for Pre- and Postoperative Pain Relief After Primary Knee Arthroplasty.Tapentadol vs Oxycodone vs Placebo Phase 3
Completed NCT02269254 - Persona Versus NexGen N/A
Completed NCT02256098 - RSA RCT: ATTUNE™ TKA Versus PFC Sigma TKA N/A
Completed NCT00815243 - Telemedicine Consultation in Trauma and Orthopedic N/A
Recruiting NCT05564182 - High Intensity Laser Therapy in the Treatment of Hemiplegic Shoulder Pain N/A
Recruiting NCT06142669 - EVOLUTION® Revision STEMMED CS Post Market Clinical Follow-up Study Protocol
Enrolling by invitation NCT04147559 - Post Market Clinical Follow-Up Study for PROFEMUR® Preserve Classic Femoral Stem
Terminated NCT02591368 - MiniTightRope Suspensionplasty Compared With LRTI for the Treatment of Basilar Thumb Arthritis N/A
Completed NCT01227694 - Adult Stem Cell Therapy for Repairing Articular Cartilage in Gonarthrosis Phase 1/Phase 2
Completed NCT00784277 - A Study to Compare the Frequency of Constipation Symptoms With Tapentadol Immediate Release (IR) Treatment Versus Oxycodone IR Treatment in Patients With End-stage Joint Disease Phase 3
Active, not recruiting NCT05618782 - Clinical Trial to Evaluate the Efficacy and Safety of LEVI-04 in Patients With Osteoarthritis of the Knee Phase 2
Recruiting NCT04029792 - Evaluation of a Combination of Plant Extracts (BSL_EP028) on Joint Mobility Phase 1/Phase 2
Active, not recruiting NCT06404346 - Comparative Effectiveness of HVT and Bowen Technique in Patients of SI Joint Dysfunction With Upslipped Innominates N/A
Terminated NCT04712019 - Evaluating Edema and Range of Motion Using Negative Pressure Therapy vs. Standard Surgical Dressing in Bilateral TKA N/A
Completed NCT05650970 - Radial Nerve Mobilization in Hand Thumb Osteoarthritis Patients N/A
Recruiting NCT06074744 - Subsartorial Nerve Block and Femoral Nerve Block in Total Knee Arthroplasty N/A
Completed NCT02315664 - MONITOR-OA: Using Wearable Activity Trackers to Improve Physical Activity in Knee Osteoarthritis N/A