Post Market Clinical Follow up Study With the Cervical Disc Prothesis MOVE®-C

NCT05035693 | Recruiting DMC

• 2 other identifiers: P004DRKS00022971
• Study Type: interventional
• Target: 170
• Locations: 2 countries
• Sites: 7

Brief Summary

Study design: International, prospective, multicentre, non-randomised, observational study according to § 23b MPG. Objectives: Observational study to confirm the safety and performance of the cervical disc prosthesis MOVE®-C.

Conditions

Discopathy; Herniated Cervical Disc; Stenoses, Spinal; Radiculopathy

Keywords

Herniated Disc; Cervical Spine; Discopathy; Radiculopathy

Outcome Measures

Primary Outcomes (2)

• Improvement from baseline on Neck Disability Index (NDI)

  Primary outcome measure 1 and 2 are combined endpoints. Improvement of the NDI of more than 15 points for a change (pre-postoperative) of up to 30 points with a standard deviation of 25 points.

  Baseline and month 24

• Improvement from baseline on Visual Analogue Scales (VAS arm/neck)

  Primary outcome measure 1 and 2 are combined endpoints. Improvement of arm and neck pain scale (VAS arm/neck) of more than 2 points at a change (pre-postoperative) of 2.7 points with a standard deviation of 2.5 points.

  Baseline and month 24

Secondary Outcomes (6)

• Change from baseline in Core Outcome Measure Index (COMI neck)

  Baseline and months 24

• Change from baseline in Short Form 36 Health Survey Questionnaire (SF-36)

  Baseline and moths 24

• Change from baseline in EuroQoL (EQ-5D-5L)

  Baseline and moths 24

• Change from baseline in Japanese Orthopedic Association Score (JOA)

  Baseline and moths 24

• Analyse of the Range of Motion (ROM)

  Baseline and moths 24

Study Arms (1)

PMCF MOVE-C

EXPERIMENTAL

PMCF MOVE®\_C is a single arm observational study with 170 patients.

Device: MOVE®-C

Interventions

MOVE®-C DEVICE

Momo- or bisegmental implantation of MOVE®-C cervical prothesis.

Also known as: cervical disc prothesis

PMCF MOVE-C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of discopathy or disc hernia with radiculopathy or stenosis of the foramen and spinal canal,
• documented individual history of neck and/or upper extremity pain and/or functional/neurological deficit associated with the cervical level to be treated,
• no surgical treatment regarding the planned index surgery within the last six weeks prior implantation,
• unsuccessful conservative medical care regarding the indication within the last six weeks,
• age ≥18 years,
• patient must agree to fully participate in the clinical trial and give informed consent in writing,
• patient is capable to realise the nature, aims and possible consequences of the clinical trial (MPG §20.2.1),
• patient information has been provided and all written consents of the patient are available.

You may not qualify if:

• Known contraindication against the use of cervical intervertebral disc prostheses in accordance with the manufacturer's instructions for use:
• Bone mineral density with T-score ≤ -1.5 as determined by spine DXA if male ≥ 60 years of age or female ≥ 50 years of age,
• active systemic infection or infection at the operative site,
• sustained osteoporotic fracture of the spine, hip or wrist,
• spinal metastases,
• known allergy to titanium or polycarbonate-urethane,
• confirmed pregnancy,
• severe cervical myelopathy,
• patients requiring a treatment that destabilises the spine (e.g. posterior element decompression),
• advanced cervical anatomical deformity at the operative site (e.g. ankylosing spondylitis, scoliosis),
• advanced degenerative changes (e.g. spondylosis) at the index vertebral level,
• patient is kept in an institution under judicial or official orders (MPG §20.3).

Sponsors & Collaborators

• NGMedical GmbH: lead

Study Sites (7)

Wiener Gesundheitsverbund-Klinik Penzing

Vienna, 1180, Austria

RECRUITING

DRK Klinikum Berlin

Berlin, 14050, Germany

RECRUITING

Wirbelsäulenzentrum Fulda Main, Kinzig

Gelnhausen, 63571, Germany

RECRUITING

Medizinisches Versorgungszentrum Steinburg

Itzehoe, 25524, Germany

RECRUITING

Katholisches Klinikum Koblenz - Montabaur

Koblenz, 56073, Germany

RECRUITING

Neurochirurgie am Gasteig

München, 81669, Germany

RECRUITING

Rhein-Maas Klinikum Würselen

Würselen, 52146, Germany

RECRUITING

MeSH Terms

Conditions

Spinal Stenosis; Radiculopathy; Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Olaf Süss, PD Dr. med.

  DRK Kliniken Berlin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saskia Mathieu, M.Sc.

CONTACT

+49687399997118; smathieu@ngmedical.de

Nino Weiland, B.Sc.

CONTACT

+49687399997104; nweiland@ngmedical.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: September 5, 2021
• Study Start: March 11, 2021
• Primary Completion: March 11, 2025
• Study Completion (Estimated): March 11, 2027
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); DE (6)