ClinicalTrials.gg
RecruitingNCT07886112RC REPROUpdated Oct 21, 2026

Evaluation of the Statistical Validity of Cervical Spine Measurements-Including Range of Motion, Strength, and Functional Test Results-for Return to Sport in Patients Who Have Undergone Surgery for Cervical Stenosis and/or Herniation.

An interventional study of Questionnaires and Physical tests in Cervical Stenosis and Cervical Spine, sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche. Recruiting at 1 site in France. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 4 years 2 months after the study started (first participant enrolled Jul 2022, registered Oct 2026).
  • Started Jul 2022; still recruiting 4 years 3 months later.
Updated Oct 21, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 40 Years
Sex
All
01

Study summary

Cervical stenosis is characterized by a narrowing of the spinal canal that exerts pressure on adjacent sensitive areas, potentially causing significant neck pain and cervicobrachial neuralgia accompanied by functional limitations-conditions that are particularly disabling for athletes. Among the athletic population, anterior cervical discectomy with fusion is the gold-standard surgical treatment. Currently, there is no consensus regarding the timing for a safe return to sports following surgical treatment for cervical stenosis. While various clinical tests are used to assess mobility or pain, no single test specifically evaluates the level of functional recovery.

02

Conditions studied

  • Cervical Stenosis
  • Cervical Spine
03

In context

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche is the lead sponsor of 204 studies on the registry; 97 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient group

Patients meeting all the following criteria will be included:

  • Male or female aged 18 to 40 years
  • Injury requiring surgery sustained during a sports activity
  • Participation in sports activity at least once a week
  • Cervical spine arthrodesis, cervical disc replacement, and/or foraminotomy
  • Surgery performed by surgeons at the Centre Orthopédique Santy (Lyon)
  • Inclusion based on the surgeon's decision during the 45-day post-operative visit

Control group

Participants meeting all the following criteria will be included:

  • Male or female aged 18 to 40 years
  • Participation in sports activity at least once a week
  • No history of cervical pathology
  • No history of surgery involving the shoulder girdle
  • No neck pain in the month prior to the test

In both groups o Patient having signed an informed consent form Subject affiliated with or a beneficiary of a social security scheme

Exclusion criteria

Exclusion Criteria:

Patient group

Patients meeting any of the following criteria will be excluded:

o Medical contraindication

Control group

Participants meeting any of the following criteria will be excluded:

  • Reported history of spinal or upper-limb injury within the last 12 months
  • Reported history of upper-limb surgery

In all cases, the following will be excluded:

  • Protected individuals: adults under guardianship, curatorship, or other legal protection; individuals deprived of liberty by judicial or administrative decision
  • Pregnant, breastfeeding, or recently delivered women
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Patients

    Cervical spine arthrodesis or cervical disc replacement and/or foraminotomy. All patients performed functionnal tests and one in two participants will be randomly selected to complete a second administration 45 days later-that is, at the 90-day mark.

    Other: Questionnaires · Other: Physical tests

  • Active comparator
    Healthy volunteers

    They performed functionnal tests followed by a second session a week later.

    Other: Questionnaires · Other: Physical tests

Interventions

  • OtherQuestionnaires

    Questionnaire Neck Disability Index (NDI) Questionnaire Neck Return to Sport after Injury (N-RSI)

  • OtherPhysical tests

    * Flexion and Extension Range of Motion * Clockwise and Counter-clockwise Rotations * Maximum isometric forces * Cervical spine flexor strength endurance * One-arm medicine ball throw * Closed Kinetic Chain Upper Extremity Stability Test modified

06

What researchers measure

Primary outcomes

  1. Questionnaire Neck Return to Sport after Injury score

    The questionnaire consists of three subscales assessing emotions, confidence in performance ability, and perceived risk of re-injury, comprising a total of 12 items rated from 0 to 10. The outcome measure (N-RSI) is derived by summing the scores of the 12 items, scaling the result to a maximum of 100, and expressing it as a percentage.

    Time frame: 45 days

07

Study locations

1 of 1 sites recruiting
  • Hôpital Privé Jean Mermoz
    Lyon, 69008, France
    Recruiting
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 21, 2026
Show all 1 update
  1. Oct 21, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07886112
Responsible party
Sponsor
First posted
Oct 21, 2026
Start date
Jul 19, 2022
Primary completion
Nov 20, 2026 (estimated)
Completion
Dec 20, 2026 (estimated)
Last update
Oct 21, 2026

Study contacts

Jean-François Oudet
Contact
jf.oudet@ecten.eu
0033683346567
Marie-Hélène Barba
Contact
mh.barba@ecten.eu

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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