Patient Reported Recovery of Muscle Strength After Surgery for Cervical Radiculopathy, Impact of Duration and Severity on Recovery.

NCT07825545 | Completed

• 1 other identifier: 03276-2
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

DCR surgery is generally recommended for patients with severe or progressive limb paresis. The incidence of motor weakness reported to be up to 70%, with a varying recovery rate up to 90%, and the prospects of recovery is most likely dependent on paresis severity and duration. Operative treatment could facilitate earlier recovery, but the evidence is weak and based on smaller and heterogeneous DCM/DCR populations. There is also a lack of knowledge concerning timing of surgery, i.e. the influence of paresis duration, surgical delay and preoperative paresis. It is also unclear if there is an association between the underlying DCR pathology (disc herniation, spondylosis or both) and prognosis. The aim of this sub-study is to assess the frequency and severity of limb preoperative paresis in patients operated for DCR, and to improve prognostication of recovery and timing of surgery. To the best of our knowledge, these issues have not been properly investigated previously. New knowledge in this field is highly sought by clinicians and can Inform patients, and physicians in shared decision making, i.e. helping them to choose more wisely between different treatment strategies. New insight in this field would be also be useful in clinical guideline development, for reducing surgical practice variation, for modifying outcome expectations, improve patient selection (clinical guideline development) and clinical outcomes of DCR surgery.

Conditions

Cervical Radicular Pain; Spondylosis, Cervical; Cervical Disc Herniation; Cervical Spine Disc Disease; Muscle Weakness

Outcome Measures

Primary Outcomes (1)

• patient reported improvement of paresis (complete)

  Follow-up strength question (3 and 12 months): "If you had reduced strength (weakness) in your shoulder/arm/hand before the operation-has this changed?" Response options: * Has become completely normal * Has improved * Unchanged * Has worsened Primary endpoint derivation (12 months): * Complete recovery = Yes: "Has become completely normal". * Complete recovery = No: all other responses.

  12 month

Secondary Outcomes (7)

• Neck disability index (NDI)

  12 month

• EuroQol-5D (EQ5D)

  12 month

• Patient and surgeon reported complications

  12 month

• NRS head

  12 month

• NRS neck

  12 month

Interventions

Anterior cervical discetomi and fusion/posterior decompression PROCEDURE

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will include consecutive patients operated for DCR and registered in NORspine form January 2012 through 2022, approximately 12.000 cases. Patients operated for cervical myelopathy will be excluded. Otherwise patients under the age of 16, those operated for fractures, tumours and primary infections, as well as those unable to give informed consent, are not included in the NORspine.

You may qualify if:

• Surgery due to degenerative cervical radiculopathy with a preoperative muscle weakness
• Posterior and anterior approach (ACDF/artificial disc replacement, posterior foramenotomi)

You may not qualify if:

• Myelopathy as surgical indication
• Tumor as surgical indication
• Infection as surgical indication
• Fracture as surgcial indication
• Posterior fusion and laminectomy
• Prior cervical surgery
• Anterior corpectomy

Sponsors & Collaborators

• University Hospital of North Norway: lead

Study Sites (1)

Neurosurgical department, University Hospital of North Norway

Tromsø, 9010, Norway

Location

Related Publications (12)

• Thome C, Kogl N, Grassner L, Vo AK, Kramer JLK, Petr O. Motor Recovery Depends on Timing of Surgery in Patients With Lumbar Disk Herniation. Neurosurgery. 2022 Mar 1;90(3):347-353. doi: 10.1227/NEU.0000000000001825. Epub 2022 Jan 17.

  PMID: 35040807 BACKGROUND

• Gebreyohanes A, Erotocritou M, Choi D. Appraising The Evidence for Conservative versus Surgical Management of Motor Deficits in Degenerative Cervical Radiculopathy. Global Spine J. 2023 Mar;13(2):547-562. doi: 10.1177/21925682221109562. Epub 2022 Jun 16.

  PMID: 35708971 BACKGROUND

• Burneikiene S, Nelson EL, Mason A, Rajpal S, Villavicencio AT. The duration of symptoms and clinical outcomes in patients undergoing anterior cervical discectomy and fusion for degenerative disc disease and radiculopathy. Spine J. 2015 Mar 1;15(3):427-32. doi: 10.1016/j.spinee.2014.09.017. Epub 2014 Sep 28.

  PMID: 25264315 BACKGROUND

• Sebastian AS, Wagner S, Butler JS, Morrissey P, Kaye ID, Kepler CK. Wednesday, September 26, 2018 7:35 AM–9:00 AM ePosters: P101. Favorable prognosis for significant preoperative upper extremity weakness following elective anterior cervical discectomy and fusion. The Spine Journal. 2018;18(8):S187. doi:10.1016/j.spinee.2018.06.639

  BACKGROUND

• Mazmudar A, Hopkins B, Hsu WK, Patel AA. 171. Postoperative recovery of motor strength and patient-reported physical function following anterior cervical discectomy and fusion. The Spine Journal. 2019/09/01/ 2019;19(9, Supplement):S83. doi:https://doi.org/10.1016/j.spinee.2019.05.188

  BACKGROUND

• Kreitz T, Huang R, Beck D, Park AG, Hilibrand A. Prolonged Preoperative Weakness Affects Recovery of Motor Function After Anterior Cervical Diskectomy and Fusion. J Am Acad Orthop Surg. 2018 Jan 15;26(2):67-73. doi: 10.5435/JAAOS-D-16-00606.

  PMID: 29239868 BACKGROUND

• Hamburger C, Festenberg FV, Uhl E. Ventral discectomy with pmma interbody fusion for cervical disc disease: long-term results in 249 patients. Spine (Phila Pa 1976). 2001 Feb 1;26(3):249-55. doi: 10.1097/00007632-200102010-00009.

  PMID: 11224860 BACKGROUND

• Lehmann CL, Buchowski JM, Stoker GE, Riew KD. Neurologic recovery after anterior cervical discectomy and fusion. Global Spine J. 2014 Feb;4(1):41-6. doi: 10.1055/s-0033-1360723. Epub 2013 Nov 15.

  PMID: 24494180 BACKGROUND

• Lee U, Kim CH, Chung CK, Choi Y, Yang SH, Park SB, Hwang SH, Jung JM, Kim KT. The Recovery of Motor Strength after Posterior Percutaneous Endoscopic Cervical Foraminotomy and Discectomy. World Neurosurg. 2018 Jul;115:e532-e538. doi: 10.1016/j.wneu.2018.04.090. Epub 2018 Apr 22.

  PMID: 29689395 BACKGROUND

• Kaiser MG, Haid RW, Shaffrey CI, Fehlings MG. Degenerative Cervical Myelopathy and Radiculopathy: Treatment Approaches and Options. Cham: Springer International Publishing AG; 2019.

  BACKGROUND

• Kristiansen JA, Balteskard L, Slettebo H, Nygaard OP, Lied B, Kolstad F, Solberg TK. The use of surgery for cervical degenerative disease in Norway in the period 2008-2014 : A population-based study of 6511 procedures. Acta Neurochir (Wien). 2016 May;158(5):969-74. doi: 10.1007/s00701-016-2760-1. Epub 2016 Mar 17.

  PMID: 26983821 BACKGROUND

• Radhakrishnan K, Litchy WJ, O'Fallon WM, Kurland LT. Epidemiology of cervical radiculopathy. A population-based study from Rochester, Minnesota, 1976 through 1990. Brain. 1994 Apr;117 ( Pt 2):325-35. doi: 10.1093/brain/117.2.325.

  PMID: 8186959 BACKGROUND

MeSH Terms

Conditions

Spondylosis; Muscle Weakness

Interventions

Gene Fusion

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Recombination, Genetic; Genetic Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant neurosurgeon

Study Record Dates

• First Submitted: September 13, 2026
• First Posted: September 17, 2026
• Study Start: January 1, 2012
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: September 17, 2026

Record last verified: 2026-09

Locations

NO (1)