Clinical trials: Reconstructive Surgery
Anterior Cruciate Ligament Reconstruction
Effectiveness of Kneehab in Strengthening Quadriceps in Rehabilitation Post Anterior Cruciate Ligament (ACL) Reconstruction
Prospective, controlled, randomized, single blind study in patients undergoing rehabilitation following anterior cruciate ligament reconstruction. 96 patients were randomly assigned to one of three groups.
- Trial name
- NMES (NCT00738010)
- Testing
- Kneehab, Poli-Stim, Control
- Where
- Germany
- Volunteers
- 131 people
- Sponsor
- Bio-Medical Research, Ltd.
Digital Nerve Injury, Nerve Injury
Evaluating Therapeutic Electrical Stimulation to Improve Nerve Healing After Surgical Repair of Digital Nerve Injuries
The goal of this clinical study is to evaluate if a period of electrical stimulation delivered during the surgical repair procedure can speed up nerve healing.
- Conditions
- Digital Nerve Injury, Nerve Injury, Nerve Reconstruction, Nerve Trauma
- Trial name
- FASTR-TEN (NCT06867185)
- Testing
- Brief Electrical Stimulation Therapy, Digital Nerve Repair
- Where
- 5 sites in United States
- Volunteers
- 60 people
- Sponsor
- Checkpoint Surgical Inc.
Anterior Cruciate Ligament Rupture
Safety and Efficacy of the Knee-T-nol Anterior Cruciate Ligament (ACL) Prosthesis
The study is designed to evaluate the safety and efficacy of implanting the Tavor ACL prosthesis in patients with a ruptured ACL by improvement of healing kinetics as well as major adverse treatment events (AEs).
- Trial name
- NCT01450332
- Testing
- Knee-T-Nol
- Where
- Israel
- Volunteers
- 20 people
- Sponsor
- Tavor Ltd.
Breast Augmentation, Breast Reconstruction
Safety and Effectiveness of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants
Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary augmentation, primary reconstruction, or revision of existing breast implants.
- Conditions
- Breast Augmentation, Breast Reconstruction, Revision of Augmentation or Reconstruction
- Trial name
- NCT00689871
- Testing
- Natrelle(TM) Silicone-Filled Breast Implants
- Where
- United States
- Volunteers
- 715 people, healthy volunteers welcome
- Sponsor
- Allergan Medical
Upper Limb Weakness Due to Central Neurologic Injury, Upper Limb Weakness Due to Peripheral Neurologic Injury
mGain - sEMG-based Gamified Therapy for Improved Upper Limb Rehabilitation
The purpose of this Phase I study is to conduct a pilot clinical trial using a mobile app-connected, wire-free surface electromyography (sEMG) system, called mGain, that provides biofeedback-based therapy in individuals with…
- Conditions
- Upper Limb Weakness Due to Central Neurologic Injury, Upper Limb Weakness Due to Peripheral Neurologic Injury, Upper Limb Weakness Due to Nerve Reconstruction, Upper Limb Weakness Due to Tendon Transfer Surgery
- Trial name
- NCT06023316
- Testing
- mGain system
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Orthocare Innovations, LLC
Lateral Ankle Instability
Study of Artelon FLEXBAND® for Patients Undergoing Soft Tissue Reconstruction of the Anterior Talofibular Ligament (ATFL) to Treat Lateral Ankle Instability
The goal of this clinical trial is to analzye return to pre-injury activity level on study participants with lateral ankle instability undergoing a modified Bröstrom reconstruction procedure for repair of the ATFL.
- Trial name
- NCT06638138
- Testing
- Flexband
- Where
- 8 sites in United States
- Volunteers
- 58 people
- Sponsor
- Stryker Trauma and Extremities
Posterior Fossa Hemorrhage, Lung Cancer
Pilot Study of Model Based Iterative Reconstruction Using 64-Slice
This study is being performed to confirm that the new technique, Model-Based Iterative Reconstruction (MBIR) with reduced radiation dose can deliver equivalent image quality for CT scans compared to current techniques (Filtered…
- Conditions
- Posterior Fossa Hemorrhage, Lung Cancer, Flank Pain, Urolithiasis
- Trial name
- MBIR (NCT01431378)
- Where
- 3 sites in United States
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- GE Healthcare
Hip Labral Tear
Study of RNS60 on Pain and Function After Hip Labral Repair
The purpose of this study is to see if use of RNS60 during hip labral repair surgery decreases pain and improves functional capacity post-operation.
- Trial name
- NCT02005523
- Testing
- RNS60, Saline
- Where
- United States
- Sponsor
- Revalesio Corporation
Intracranial Aneurysm
The Registry to Study Safety and Performance of the CORDIS Vascular Reconstruction Device and Delivery System
The objective of the registry is to evaluate the real world safety and performance of the CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System (VRD) to facilitate endovascular coil embolization of intracranial…
- Trial name
- SUNRISE (NCT00486226)
- Testing
- Vascular Reconstruction Device
- Where
- Belgium
- Volunteers
- 105 people
- Sponsor
- Codman & Shurtleff
Breast Reconstruction
Clinical and Economic Outcomes With the Use of SERI® Surgical Scaffold in Direct-to-implant Breast Reconstruction
The objective of this study is to prospectively observe clinical and economic outcomes with the use of SERI® in direct-to-implant breast reconstruction.
- Trial name
- NCT02033590
- Testing
- Biodegradable (purified) surgical silk scaffold
- Sponsor
- Sofregen Medical, Inc.
Breast Cancer, Hereditary Breast/Ovarian Cancer (brca1, brca2)
Outcomes After Perforator Flap Reconstruction for Breast Reconstruction and/or Lymphedema Treatment
The goal of this prospective, observational study is to investigate the clinical, psychosocial, and patient satisfaction outcomes of patients who undergo perforator flap reconstruction for breast reconstruction and/or…
- Conditions
- Breast Cancer, Hereditary Breast/Ovarian Cancer (brca1, brca2), Acquired Lymphedema, Congenital Lymphedema
- Trial name
- NCT01273909
- Testing
- Perforator Flap Breast Reconstruction, Vascularized Lymph Node Transfer
- Where
- 3 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- The National Institute of Lymphology
Hallux Valgus Repairs, Medial or Lateral Instability Repairs/Reconstructions
A Study of the Safety and Performance of the MINITAC◊ Titanium 2.0 Suture Anchor
This is a retrospective study evaluating the safety and performance of the MINITAC Suture anchors for extremities repair. Data will be used to support Notified Body (BSI) requirements for extremities repair indications.
- Conditions
- Hallux Valgus Repairs, Medial or Lateral Instability Repairs/Reconstructions, Achilles Tendon Repairs/Reconstructions, Midfoot Reconstructions
- Trial name
- MINITAC (NCT04186481)
- Testing
- MINITAC Ti 2.0 suture anchor
- Where
- Australia
- Volunteers
- 32 people
- Sponsor
- Smith & Nephew, Inc.
ACL Rupture
Clinical Performance and Safety of ENDOPACK® DT4-EBMCA in ACL Reconstruction 24 Months Post-surgery
Anterior cruciate ligament (ACL) injuries are among the most common sports-related knee traumas. The DT4-EBMCA device, based on a quadrupled semitendinosus autograft technique, aims to provide effective and minimally invasive…
- Trial name
- DT4-EBMCA (NCT06990100)
- Testing
- ACL surgery
- Where
- France
- Volunteers
- 36 people
- Sponsor
- SACIMEX
ACL Tears
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
This research study will evaluate mid-term clinical safety and performance outcomes of the BioBrace® Reinforced Implant when used to augment a tissue graft during anterior cruciate ligament (ACL) reconstruction.
- Trial name
- NCT06948591
- Testing
- Anterior cruciate ligament reconstruction with BioBrace® augmentation, Arthroscopic anterior cruciate ligament reconstruction
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- CONMED Corporation
Breast Reconstruction, Revision Breast Reconstruction
A Study of the Safety and Effectiveness of the Mentor Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction
The study will evaluate the long-term safety and effectiveness with the Mentor MemoryGel® Larger Size Ultra High Profile (UHP-L) Breast Implants.
- Trial name
- Athena (NCT02724371)
- Testing
- Mentor Larger Size MemoryGel Ultra High Profile Breast Implant
- Where
- 30 sites in United States
- Volunteers
- 400 people
- Sponsor
- Mentor Worldwide, LLC
Thoracoabdominal Aortic Aneurysm, Pararenal Aortic Aneurysm
Guo's Visceral Arteries Reconstruction: First in Man Study
A First in man study to evaluate the safety and efficacy of thoracoabdominal aortic stent system for thoracoabdominal aortic aneurysms and pararenal abdominal aortic aneurysm.
- Trial name
- NCT04731636
- Testing
- Thoracoabdominal aortic stent system
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Breast Cancer
Post-op Outcomes of Enhanced Energy Delivery Dissection for Mastectomy With Immediate Breast Reconstruction
Principal Investigator: Sheldon Feldman, MD Co-Principal Investigator: Mohamad Sebai, MD Department of Surgery, Montefiore Medical Center - Einstein College of Medicine Title Pilot Study: Post-operative outcomes of enhanced…
- Trial name
- NCT03627442
- Testing
- Mastectomy with PhotonBlade, Mastectomy with Bovie
- Volunteers
- 15 people
- Sponsor
- Invuity, Inc.
Multiligament Knee Injuries
OrthoPureXT Multiligament PMCF Study
To monitor residual risks in the post-market phase and to ensure continued clinical evaluation of the device safety and performance to ensure that no new or unexpected risks arise when used during multi-ligament knee…
- Trial name
- NCT05655156
- Testing
- OrthoPure XT
- Where
- United Kingdom
- Volunteers
- 28 people
- Sponsor
- Tissue Regenix Ltd
Full-thickness Skin Defects, Degloving Injuries
RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction
A prospective randomized within-subject controlled study to compare the clinical performance of conventional autografting with and without the RECELL system on acute non-burn full-thickness skin defects.
- Conditions
- Full-thickness Skin Defects, Degloving Injuries, Crush Injuries, Laceration of Skin
- Trial name
- NCT04091672
- Testing
- Control Intervention (Conventional Autograft), Investigational Intervention (RECELL + more widely meshed autograft)
- Where
- 18 sites in United States
- Volunteers
- 65 people
- Sponsor
- Avita Medical
Seroma, Necrosis
Retrospective Analysis of Veritas in Breast Reconstruction
Retrospective data collection of the use of Veritas in breast reconstruction surgery
- Conditions
- Seroma, Necrosis, Infection
- Trial name
- RAVE (NCT01454713)
- Where
- 3 sites in United States
- Volunteers
- 54 people
- Sponsor
- Baxter Healthcare Corporation