Wounds and Injuries

All Conditions

Musculoskeletal Diseases

Blood and Lymph Conditions

Neoplasms

Nervous System Diseases

Fractures, Bone

Intervertebral Disc Degeneration

Bone Marrow Diseases

Spinal Fractures

Spinal Cord Neoplasms

Spinal Neoplasms

Spinal Cord Diseases

Spinal Diseases

Bone Diseases

Central Nervous System Diseases

Central Nervous System Neoplasms

Nervous System Neoplasms

Bone Neoplasms

Spinal Injuries

Back Injuries

Alll patients which were treated with the Ennovate® Cervical system in accordance with the indications given in the instructions for use

The Ennovate® Cervical Spinal System is a posterior stabilization for the cervical and upper-thoracic spine. The implants are used for the posterior monosegmental and multisegmental stabilization of the occipitocervical junction and of the cervical and upper thoracic spine.

posterior stabilization for the cervical spine

Sarah Mattes

Stefan Maenz, Dr.

Felix Kiepe, Dr.

Klaus Röhl, Dr.

Philip Gierer, Prof. Dr.

Gierer, Prof. Dr.

Multicenter Post market clinical follow-up Study on the Safety and Performance of Ennovate® Cervical - Prospective, pure data collection of all Ennovate Cervical patients in Total Indications

This clinical study is one of the Post market clinical follow-up measures that enables the manufacturer to monitor the clinical safety and performance of the Ennovate® Cervical system. The study enables a quick, but detailed implant documentation, which is of great interest for the current and future users of the internal fixation system targeted in this study. It includes the relevant outcomes to evaluate safety and efficacy of the implant system for various indications in trauma and degenerative disorders.

Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical

Multicenter Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical - a Prospective Study on Total Indications

Pain will be assessed by the patient using the Visual Analogue Scale (VAS) which states "0" at one end representing "no pain" and "100" at the opposite end representing "maximal/worst pain".

In order to analyze the quality of life of the patients, the 5-dimension 5-level score of EuroQol Group (EQ-5D-5L) is used. The score is self-completed by the patient. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

The Japanese Orthopaedic Association (JOA) myelopathy score is a disease-specific and physician oriented system that mainly assesses the neurological status of the patient and enables surgeons to compare the changes in the neurological status of the patient before and after certain treatments. However, the JOA score does not include patients' satisfaction, disability, handicaps, or general health (physical and mental health), which can be affected by cervical myelopathy.

The Neck Disability Index (NDI) is designed to measure neck-specific disability. The questionnaire has 10 items to measure patient-reported disability secondary to neck pain and activities of daily living including personal care, lifting, reading, headaches, concentration, work status, driving, sleeping and recreation and patients rate their status from 0 (best) to 5 (worst imaginable). Individual item responses are summed to a total score, where 0 points indicate no activity limitations and 50 points indicate complete activity limitation.

After cervical stabilization fusion of the treated segment is aspired in most cases. The fusion status can be determined from radiographs (static or dynamic). Bony fusion can be characterized quantitatively by the fusion rate.

Occurrence of complications potentially associated with the implanted devices can never be fully excluded during spinal surgery. In order to monitor potential complication and to identify so far unknown complications Adverse Events and Serious Adverse Events deemed related to the investigational device are recorded.

Raylytic GmbH

Aesculap AG

Diseases and Abnormalities at or Before Birth

Congenital Abnormalities

Hanqiang Ouyang

Yuanyu Hu

Weishi Li

Unplanned re-operation is one of the common negative indicators reflecting the quality and safety of surgery in the medical industry and has become one of the ten goals for the improvement of national medical quality and safety in China since 2022, while about 40% of unplanned re-operations in Peking University Third Hospital in recent years occur in spine patients of the orthopedics department. This project intends to establish a high-quality and sustainable ambispective disease cohort for spine surgery in Peking University Third Hospital based on the unplanned re-operations that occurred in the Orthopedics Department of Peking University Third Hospital from January 2012 to December 2025. The investigators further summarize and analyze clinical causes and risk factors of re-operations, aiming to explore scientific coping strategies and provide reference for continuous improvement of medical service quality.

Unplanned re-operation is one of the common negative indicators reflecting the quality and safety of surgery in the medical industry. Possible reasons for a patient's return to the operating room include problems with surgical technique, anesthesia procedures, or infection control. Reducing the rate of unplanned re-operation has become one of the ten goals for the improvement of national medical quality and safety in China since 2022, and has been paid more and more attention by the National Health Commission and hospital managers.

About 40% of the unplanned re-operations in Peking University Third Hospital in recent years occur in spine patients of the orthopedics department, thus lowering the rate of spine unplanned re-operations is of great significance to improve the overall medical quality and safety. Driven by the common needs and joint force of "nation-hospital-department", this project intends to establish a high-quality and sustainable ambispective disease cohort for spine surgery in Peking University Third Hospital based on unplanned re-operations that occurred in the Orthopedics Department of Peking University Third Hospital from January 2012 to December 2025. The investigators further summarize and analyze clinical causes and risk factors of re-operations, aiming to explore scientific coping strategies and provide reference for continuous improvement of medical service quality. Furthermore, the investigators intend to construct multiple risk prediction models for spine unplanned re-operation and special disease cohorts. This project will form a synergy in the three aspects of "clinical, scientific research, and management", lower the unplanned re-operation rate of orthopedic spinal surgery, improve medical quality and safety management in Peking University Third Hospital, and promote the in-depth exploration and vigorous development of spine discipline in the scientific fields of perioperative safety and risk assessment.

Reasons and Risk Factors for Unplanned Spinal Re-operation

Construction of an Ambispective Cohort for Unplanned Spinal Re-operation

We calculate the unplanned re-operation incidences in total and that of specialized spinal diseases.

We summarize reasons of spine unplanned re-operation in total and that of specialized spinal diseases.

We figure out risk factors of spine unplanned re-operation and that of specialized spinal diseases by comparing conditions between patients underwent unplanned re-operation or not.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical	NCT05296889	Spine Fracture Degenerative Di... Spinal Instabil... Spinal Tumor Degenerative My...	posterior stabi...	18 Years -	Aesculap AG
Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical	NCT05296889	Spine Fracture Degenerative Di... Spinal Instabil... Spinal Tumor Degenerative My...	posterior stabi...	18 Years -	Aesculap AG
Reasons and Risk Factors for Unplanned Spinal Re-operation	NCT05995327	Degeneration Sp... Spine Deformity Spine Tumor Spine Fracture		18 Years - 80 Years	Peking University Third Hospital

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