Observational Prospective PMCF Study to Confirm Performance and Safety of Intelect® Devices in Real World

DJO UK Ltd144 enrolled

Overview

DJO UK Ltd (ENOVIS) is conducting this study to confirm the performance and safety of the Chattanooga Intelect® devices in real world use. This study will record post market clinical data on the use of a number of MDR-CE marked devices that are part of the Chattanooga Intelect® device family to ensure the continued acceptability of the benefit-risk ratio, and to identify possible systematic misuse or off-label use of the devices (Intelect® Mobile 2 Combo, Intelect® Mobile 2 Ultrasound, Intelect® Mobile 2 Electrotherapy (Stim), Intelect® Transport 2 Combo and Intelect® Transport 2 Ultrasound).

This clinical investigation is a post-market, real word, international, multi center, prospective, observational study to confirm the safety and performance of the Chattanooga Intelect® when used in accordance with their approved intended use, to comply with Medical Device Regulation (EU) 2017/745 (MDR) Article 61 and Part B of Annex XI.

Study Type

OBSERVATIONAL

Enrollment

144

Conditions

Musculoskeletal Disorders Skeletal Disorder Muscle Disorder

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with musculoskeletal and skeletal muscle deficit disorders assigned to be treated with any of the Intelect® devices according to the current clinical practice at the selected sites and based on the opinion of the Investigator. 2. Patient male or female with age ≥18 years old. 3. Patient able to provide written informed consent. For France only: To be affiliated to the social security system or to be beneficiary of such system Exclusion Criteria: 1. Patients participating in another clinical study or who have completed a clinical study less than 30 days prior to enrollment. 2. Patients who for any reason e.g. significant co-morbidities or other reasons, are considered by the Investigator unsuitable for study participation.

Locations (4)

Attal Cabinet

Serris, France

COMPLETED

Casertafisio

Caserta, Italy

RECRUITING

Rachis Center

Roma, Italy

RECRUITING

Dr Chad Woods Physiotherapy

Peebles, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

Pain reduction

Pain reduction measured with Visual Analog Scale (VAS) (in a scale 0-100 mm, where 0 is no pain and 100 is the worst possible pain) at end of treatment compared to pre-treatment (baseline) VAS in the TENS/US group

Time frame: from treatment start to treatment end (about 6 weeks)

Secondary Outcomes

Muscle reeducation

Improvement in muscle re-education demonstrated by score on a digital dynamometer at the end of treatment compared to baseline in the NMES group

Time frame: from treatment start to treatment end (about 6 weeks)

Range of motion (ROM) improvement

Maintenance or increasing of the ROM demonstrated by a goniometer the end of treatment compared to baseline in the NMES group

Time frame: from treatment start to treatment end (about 6 weeks)

Clinical status improvement

Improvement in patient clinical status using the Global Clinical Assessment of improvement questionnaire at the end of the treatment in the NMES group

Time frame: end of study (about 12 weeks)

Safety - adverse event rate

Proportion of patient experiencing an adverse event associated with device use

Time frame: through study completion, an average of 15 weeks

Observational Prospective PMCF Study to Confirm Performance and Safety of Intelect® Devices in Real World

Overview

Conditions

Eligibility

Locations (4)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts