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Head-neck Coordination Analysis After Minimally Invasive Surgery in the Dorsal Cervical Spine (MISDCS)

S

Schoen Klinik Hamburg Eilbek

Status

Unknown

Conditions

Multilevel Cervical Spinal Stenosis
Single Brachial Radiculopathy

Treatments

Procedure: Transmuscular approach for foraminotomy
Procedure: Subperiosteal approach for foraminotomy
Procedure: Bilateral approach for Laminoplasty
Procedure: Unilateral approach for laminoplasty

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

To proof patients' benefit of minimally invasive surgery in the dorsal cervical spine an apparatus to examine head-neck-coordination was constructed.

Two different surgical techniques will be compared:

Laminoplasty: open approach vs minimally invasive surgery (MIS)-approach; Foraminotomy: open approach vs MIS-approach. Each patient will be tested before surgery, postoperative as well as 3 and 12 month follow-up.

Hypothesis is that patients after MIS-approaches perform better in their head-neck-coordination as patients with open approaches.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • radicular or myelopathic compression syndrome in the cervical spine

Exclusion criteria

  • neurological diseases with influence on the neuromuscular function
  • previous surgery on the cervical spine

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 4 patient groups

Bilateral approach for laminoplasty
Active Comparator group
Description:
Open approach for laminoplasty
Treatment:
Procedure: Bilateral approach for Laminoplasty
Unilateral approach for laminoplasty
Active Comparator group
Description:
Minimally invasive approach for laminoplasty
Treatment:
Procedure: Unilateral approach for laminoplasty
Subperiosteal approach for foraminotomy
Active Comparator group
Description:
Open approach for foraminotomy
Treatment:
Procedure: Subperiosteal approach for foraminotomy
Transmuscular approach for foraminotomy
Active Comparator group
Description:
Minimally invasive approach for foraminotomy
Treatment:
Procedure: Transmuscular approach for foraminotomy

Trial contacts and locations

1

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Central trial contact

Ralph Kothe, MD; Alexander Gude, MD

Data sourced from clinicaltrials.gov

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