Odontoid FractureNCT06961578
SCORE Study: Comparing Surgery and Rigid Collar Treatment for Odontoid Fractures in Adults Over 70
A study testing C1-2 instrumentation and External immobilization with rigid cervical collar in people with Odontoid Fracture and Elderly, run by Technical University of Munich at 16 sites in Germany.
Trial summary
The goal of this clinical trial is to compare two treatment options-surgery or rigid collar bracing-for unstable neck fractures (odontoid fractures) in adults aged 70 years and older. These fractures are common in older adults and can significantly impact mobility, independence, and quality of life. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Odontoid Fracture, Elderly
- What is being tested?
- C1-2 instrumentation and External immobilization with rigid cervical collar
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- 16 sitesGermany
- Study dates
- 13 Aug 2025to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- At least 70 years old
- Acute unstable OFs (types II, III as classified by Anderson and d'Alonzo, and atypical)
- Less than two weeks post injury
- Written informed consent
Who cannot join
- Previous treatment for odontoid fracture
- Concomitant fractures of the subaxial cervical spine necessitating surgery
- Significant comorbidity resulting in inoperability of the patient: i.e. ASA score > 4
- Neurological compromise due to displaced fracture
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
Germany16 sites, 16 recruiting
- Not yet recruiting
Department of Neurosurgery, RWTH Aachen University
Aachen
Christian Blume, Dr., +49241 80-88476, cblume@ukaachen.de
- Recruiting
Charité University Hospital Berlin
Berlin, State of Berlin, 10117
Peter Vajkoczy, Prof. Dr., +49 30 450 660 409, peter.vajkoczy@charite.de
- Not yet recruiting
Department of Neurosurgery and Spine Center, HELIOS Hospital Berlin Buch
Berlin
Yu-Mi Ryang, Prof. Dr., +493094 01-54300, yumi.ryang@helios-gesundheit.de
- Not yet recruiting
Department of Orthopaedic and Traumatology, University of Cologne
Cologne
Peer Eysel, Prof. Dr., +49 221 478-4601, peer.eysel@uk-koeln.de
- Not yet recruiting
Department of Orthopedics, Medical University at Dresden
Dresden
Alexander Carl Disch, Prof. Dr., +49351 458-3840, alexander.disch@uniklinikum-dresden.de
- Not yet recruiting
Department of Neurosurgery and Spine Surgery, University Hospital Essen
Essen
Oliver Gembruch, Dr., +49 (0)201 723 1210, neurosurgery@uk-essen.de
- Not yet recruiting
Center for Spinal Surgery and Neurotraumatology, Berufsgenossenschaftliche Unfallklinik
Frankfurt am Main, Hesse, 60389
Frank Kandziora, Prof. Dr., +4969 475-2018, ws@bgu-frankfurt.de
- Not yet recruiting
Department of Neurosurgery, University Medical Center Göttingen
Göttingen
Veit Rohde, Prof. Dr., +49551 39-61777, veit.rohde@med.uni-goettingen.de
- Not yet recruiting
Department of Trauma and Reconstructive Surgery, BG Klinikum Bergmannstrost Halle
Halle
Bernhard Ulrich, Dr. med., +49345 132 - 66 32, uc-leitendeaerzte@bergmannstrost.de
- Not yet recruiting
Department of Neurosurgery, University Hospital Heidelberg
Heidelberg
Sandro Krieg, Prof. Dr., +496221 56-6300, neurochirurgie@med.uni-heidelberg.de
- Recruiting
Department of Neurosurgery, University Hospital of Lausitz
Lausitz
Ehab Shiban, Prof. Dr., +49 355 46 3111, neurochirurgie@mul-ct.de
- Not yet recruiting
Department of Orthopaedics, Trauma Surgery and Plastic Surgery, University of Leipzig
Leipzig
Nicolas von der Höh, Dr., +49341 - 97 23103, nicolas.vonderhoeh@medizin.uni-leipzig.de
- Not yet recruiting
Spine Surgery, Orthopedic Hospital Markgröningen GmbH
Markgröningen
Marc Dreimann, Dr., +497145-91-53241, gabriela.schroeder@rkh-gesundheit.de
- Not yet recruiting
LMU University Hospital
Munich, Bavaria, 81377
Florian Ringel, Prof. Dr., +49 89 4400-72591, florian.ringel@med.uni-muenchen.de
- Not yet recruiting
BG Trauma Centre, Eberhard Karls University of Tuebingen
Tübingen
Andreas Badke, Dr., +497071 606-1046, ABadke@bgu-tuebingen.de
- Not yet recruiting
Spine Center, St. Josefs-Hospital Wiesbaden
Wiesbaden
Philipp Hartung, Dr., +49611 177 3701, phartung@joho.de
About this study
Official title: Surgical Versus Conservative Treatment of Odontoid Fractures in the Elderly: A Randomised Controlled Clinical Study (SCORE)
The goal of this clinical trial is to compare two treatment options-surgery or rigid collar bracing-for unstable neck fractures (odontoid fractures) in adults aged 70 years and older. These fractures are common in older adults and can significantly impact mobility, independence, and quality of life. There is currently no clear evidence to determine which treatment is better for this population. The main questions it aims to answer are:
- Does surgery or conservative collar treatment lead to better improvement in daily living, measured by the Barthel Index, after 12 weeks?
- What are the differences in pain, disability, and quality of life between the two treatments?
Read more
The study team will compare patients who receive surgical stabilization with those who are treated with a rigid cervical collar to see which approach supports better functional outcomes and healing.
Participants will:
- be randomly assigned to either surgery (posterior C1-C2 screw-rod fixation) or conservative collar treatment
- attend study visits at 12 weeks and 6 months
- complete questionnaires on daily functioning, pain, and quality of life
- undergo CT scans and other medical assessments
- record collar use (for conservative group) in a diary
- be monitored for any complications or changes in treatment (including crossover to surgery if needed)
The study aims to include 322 participants to provide evidence on which treatment helps older adults recover better from odontoid fractures with fewer complications and improved quality of life.
Read the detailed description
The SCORE study is a multicenter, randomized, controlled, open-label, parallel-group non-inferiority trial designed to provide evidence on whether conservative treatment is non-inferior to surgical stabilization regarding recovery of daily functioning.
Study Objectives A) Primary Objective: To compare the effectiveness of surgical versus conservative treatment for unstable OFs in patients aged 70 or older in terms of recovery in activities of daily living, measured by the change in Barthel Index (BI) from baseline to 12 weeks.
- Secondary Objectives: To compare the effects of treatment on:
- Quality of life (EQ-5D)
- Neck pain (Visual Analog Scale)
- Neck-specific disability (Neck Disability Index)
- Radiographic fracture healing
- Treatment compliance
- Rate of crossover from conservative to surgical treatment
- Incidence of adverse and serious adverse events
This is a prospective, two-arm, multicenter, randomized controlled non-inferiority trial with parallel-group design. Patients will be randomized 1:1 to receive either surgical stabilization (posterior C1-C2 screw-rod fixation) or conservative treatment with a rigid cervical collar. Randomization will be stratified by center using permuted blocks via the secure online platform randomizer.at. Participants are followed up at 12 weeks and 6 months post-injury. An additional visit ~2 weeks after surgery is conducted for those undergoing surgical treatment. Patients in the conservative arm may cross over to surgery up to week 12, based on clinical indication or patient preference.
Intervention Descriptions A) Surgical Group: Posterior stabilization using a screw-rod system without additional external bracing. The surgery lasts ~100 minutes and requires ~6 days of hospital stay. This approach is tailored for geriatric patients and excludes anterior fixation due to biomechanical concerns in the elderly.
- Conservative Group: External immobilization using a rigid cervical collar for 12 weeks. Compliance is monitored via patient diaries, acknowledging real-world challenges in consistent brace use. Lack of adherence is considered reflective of routine clinical practice.
Statistical Analyses The primary analysis will assess non-inferiority of conservative treatment versus surgery using a mixed model for repeated measures (MMRM) of the BI at 12 weeks. Covariates include treatment, time, interaction terms, baseline BI, age, and CCI; study center is treated as a random effect (excluded if convergence fails). Non-inferiority is defined by a margin of 5 BI points, which is more conservative than the minimal clinically important difference (MCID) of 9.8 and closer to the smallest detectable change (SDC) of 3.0, based on prior studies. The study has 90% power to detect non-inferiority (one-sided α = 0.025). A total of 137 patients per arm (274 total) are needed, inflated to 322 to account for 15% attrition.
Secondary analyses will use similar mixed models for continuous variables and generalized estimating equations for binary outcomes. Sensitivity analyses include "as-treated" models accounting for crossover. No adjustment for multiple comparisons will be made.
Randomization Procedure Randomization is conducted after informed consent via randomizer.at. Lists are stratified by center and use permuted blocks. Access is password-protected and managed by study personnel.
An independent Data and Safety Monitoring Board (DSMB) will oversee the study. All adverse events and serious adverse events are recorded at each visit and coded per MedDRA prior to analysis.
- Conditions
- Odontoid Fracture, Elderly
- Being tested
- C1-2 instrumentation, External immobilization with rigid cervical collar
- Keywords
- Odontoid fracture, C2 fracture, atlantoaxial instability, atlantoaxial fusion, Barthel Index, functional outcome
- Medical subject headings
- Atlanto-Axial Fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C1-2 instrumentationProcedure or surgery
Also called Spondylodesis, fusion
Surgical fracture stabilization with a posterior screw-rod system from C1-2 from a posterior approach.
The routine surgery commonly lasts approximately 100 minutes and requires a hospital stay of about 6 days. An additional external bracing in the postoperative setting is not required.
External immobilization with rigid cervical collarOther
External immobilization with a rigid cervical collar for 12 weeks. Compliance is monitored through patient diaries, recognizing the real-world challenges of consistent brace use. Lack of adherence is considered to reflect routine clinical practice. A typical drawback of the conservative intervention in daily practice is the absolute reliance on patient compliance to wear the collar continuously for at least 12 weeks, which poses a significant challenge to this treatment strategy.
| Study group | Role | What they receive |
|---|---|---|
| Conservative Group | Experimental | conservative group subjected to external collar bracing Receives: Other: External immobilization with rigid cervical collar |
| Surgical Group | Experimental | surgical group undergoing C1-2 instrumentation Receives: Procedure: C1-2 instrumentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barthel Index
Change in Barthel Index (BI) between baseline and 12 weeks thereafter
Measured: Baseline to 12 weeks
Secondary outcomes (9)
Change in quality of life assessed by the EuroQol 5 Dimensions (EQ-5D)
Change in quality of life assessed by the EQ-5D between baseline, 12 weeks and 6 months. Minimum score 0, Maximum score 100, higher scores denote higher perceived quality of life.
Measured: Baseline to 12 weeks and to 6 months.
Duration of surgery
Duration of surgery for the surgery/intervention group.
Measured: Baseline value (time of surgery)
Duration of time per day the cervical collar is worn (patient/proxy protocol)
Duration of time per day the cervical collar is worn (patient/proxy protocol)
Measured: Baseline to 12 weeks
Neck-Disability-Index (NDI)
Patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation.
Measured: Baseline, 12 weeks and 6 months after surgery/intervention
Charlson Comorbidity Index (CCI)
Charlson Comorbidity Index predicts the ten-year mortality for a patient who may have a range of comorbid conditions.
Measured: Baseline value
Union rate of fracture
Union rate of fracture assessed by CT scan after 12 weeks
Measured: 12 weeks after surgery/intervention
Readmission to hospital
Readmission to hospital from baseline to 12 weeks to 6 months.
Measured: Baseline to 12 weeks to 6 months
Cross-over rate
Cross-over rate from conservative to surgical arm
Measured: Baseline to 12 weeks
Change in Visual Analogue Scale Pain (VAS)
Change in VAS between baseline, postoperative/at discharge (5 - 14 days post surgery), 12 weeks and 6 months after surgery/intervention
Measured: baseline, immediately after surgery/intervention, 12 weeks after surgery/intervention and 6 months after surgery/intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start13 Aug 2025
- Primary completion12 Dec 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Odontoid FractureStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, prospective, multi-center, open-label, randomized, controlled non-inferiority clinical study in a parallel group design
- Masking
- None (open label)
- Enrolment
- 322 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- St. Josefs-Hospital Wiesbaden GmbH, Medical University of Cologne, BG Trauma Center Tuebingen, RWTH Aachen University, University Hospital Heidelberg, University Hospital, Essen, BG Klinikum Bergmannstrost, Halle, Germany, Helios Klinikum Berlin-Buch, German Federal Ministry of Education and Research, Charite University, Berlin, Germany
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961578
- Sponsor's protocol ID
- 2024-630-S-NP
- Other IDs
- 01KG2405
- Status last verified
- May 2025
- First submitted
- 20 Apr 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wagner A, Albrecht C, Dittmer S, Egert-Schwender S, Kehl V, Stichling R, Klatt G, Ettinger B, Hecht N, Vajkoczy P, Wengert A, Kandziora F, von der Hoh NH, Heyde CE, Hartung P, Richter M, Lenz M, Eysel P, Badke A, Blume C, Clusmann H, Walter J, Krieg S, Evangelou P, Shiban E, Dreimann M, Gembruch O, Sure U, Bettag C, Rohde V, Disch A, Bekele B, Ryang YM, Kramer A, Ringel F, Wach J, Guresir E, Meyer B, Wostrack M. Surgical versus conservative treatment of odontoid fractures in the elderly: A randomized controlled clinical study (SCORE). PLoS One. 2025 Dec 23;20(12):e0337999. doi: 10.1371/journal.pone.0337999. eCollection 2025.
PubMed 41433244
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Versus Conservative Treatment of Odontoid Fractures in the Elderly: A Randomised Controlled Clinical Study (SCORE)
- ClinicalTrials.gov ID
- NCT06961578
- Acronym / sponsor ID
- 2024-630-S-NP
- Conditions
- Odontoid Fracture, Elderly
- Keywords
- Odontoid fracture, C2 fracture, atlantoaxial instability, atlantoaxial fusion, Barthel Index, functional outcome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 322 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- St. Josefs-Hospital Wiesbaden GmbH, Medical University of Cologne, BG Trauma Center Tuebingen, RWTH Aachen University, University Hospital Heidelberg, University Hospital, Essen, BG Klinikum Bergmannstrost, Halle, Germany, Helios Klinikum Berlin-Buch, German Federal Ministry of Education and Research, Charite University, Berlin, Germany
- Study start
- 13 Aug 2025 (actual)
- Primary completion
- 12 Dec 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare two treatment options-surgery or rigid collar bracing-for unstable neck fractures (odontoid fractures) in adults aged 70 years and older. These fractures are common in older adults and can significantly impact mobility, independence, and quality of life. There is currently no clear evidence to determine which treatment is better for this population. The main questions it aims to answer are:
- Does surgery or conservative collar treatment lead to better improvement in daily living, measured by the Barthel Index, after 12 weeks?
- What are the differences in pain, disability, and quality of life between the two treatments?
The study team will compare patients who receive surgical stabilization with those who are treated with a rigid cervical collar to see which approach supports better functional outcomes and healing.
Participants will:
- be randomly assigned to either surgery (posterior C1-C2 screw-rod fixation) or conservative collar treatment
- attend study visits at 12 weeks and 6 months
- complete questionnaires on daily functioning, pain, and quality of life
- undergo CT scans and other medical assessments
- record collar use (for conservative group) in a diary
- be monitored for any complications or changes in treatment (including crossover to surgery if needed)
The study aims to include 322 participants to provide evidence on which treatment helps older adults recover better from odontoid fractures with fewer complications and improved quality of life.
Detailed description
The SCORE study is a multicenter, randomized, controlled, open-label, parallel-group non-inferiority trial designed to provide evidence on whether conservative treatment is non-inferior to surgical stabilization regarding recovery of daily functioning.
Study Objectives A) Primary Objective: To compare the effectiveness of surgical versus conservative treatment for unstable OFs in patients aged 70 or older in terms of recovery in activities of daily living, measured by the change in Barthel Index (BI) from baseline to 12 weeks.
- Secondary Objectives: To compare the effects of treatment on:
- Quality of life (EQ-5D)
- Neck pain (Visual Analog Scale)
- Neck-specific disability (Neck Disability Index)
- Radiographic fracture healing
- Treatment compliance
- Rate of crossover from conservative to surgical treatment
- Incidence of adverse and serious adverse events
This is a prospective, two-arm, multicenter, randomized controlled non-inferiority trial with parallel-group design. Patients will be randomized 1:1 to receive either surgical stabilization (posterior C1-C2 screw-rod fixation) or conservative treatment with a rigid cervical collar. Randomization will be stratified by center using permuted blocks via the secure online platform randomizer.at. Participants are followed up at 12 weeks and 6 months post-injury. An additional visit ~2 weeks after surgery is conducted for those undergoing surgical treatment. Patients in the conservative arm may cross over to surgery up to week 12, based on clinical indication or patient preference.
Intervention Descriptions A) Surgical Group: Posterior stabilization using a screw-rod system without additional external bracing. The surgery lasts ~100 minutes and requires ~6 days of hospital stay. This approach is tailored for geriatric patients and excludes anterior fixation due to biomechanical concerns in the elderly.
- Conservative Group: External immobilization using a rigid cervical collar for 12 weeks. Compliance is monitored via patient diaries, acknowledging real-world challenges in consistent brace use. Lack of adherence is considered reflective of routine clinical practice.
Statistical Analyses The primary analysis will assess non-inferiority of conservative treatment versus surgery using a mixed model for repeated measures (MMRM) of the BI at 12 weeks. Covariates include treatment, time, interaction terms, baseline BI, age, and CCI; study center is treated as a random effect (excluded if convergence fails). Non-inferiority is defined by a margin of 5 BI points, which is more conservative than the minimal clinically important difference (MCID) of 9.8 and closer to the smallest detectable change (SDC) of 3.0, based on prior studies. The study has 90% power to detect non-inferiority (one-sided α = 0.025). A total of 137 patients per arm (274 total) are needed, inflated to 322 to account for 15% attrition.
Secondary analyses will use similar mixed models for continuous variables and generalized estimating equations for binary outcomes. Sensitivity analyses include "as-treated" models accounting for crossover. No adjustment for multiple comparisons will be made.
Randomization Procedure Randomization is conducted after informed consent via randomizer.at. Lists are stratified by center and use permuted blocks. Access is password-protected and managed by study personnel.
An independent Data and Safety Monitoring Board (DSMB) will oversee the study. All adverse events and serious adverse events are recorded at each visit and coded per MedDRA prior to analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm, prospective, multi-center, open-label, randomized, controlled non-inferiority clinical study in a parallel group design
| Arm | Type | Receives |
|---|---|---|
| Conservative Group | Experimental | Other: External immobilization with rigid cervical collarconservative group subjected to external collar bracing |
| Surgical Group | Experimental | Procedure: C1-2 instrumentationsurgical group undergoing C1-2 instrumentation |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- At least 70 years old
- Acute unstable OFs (types II, III as classified by Anderson and d'Alonzo, and atypical)
- Less than two weeks post injury
- Written informed consent
Key exclusion criteria (4 listed)
- Previous treatment for odontoid fracture
- Concomitant fractures of the subaxial cervical spine necessitating surgery
- Significant comorbidity resulting in inoperability of the patient: i.e. ASA score > 4
- Neurological compromise due to displaced fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C1-2 instrumentationAlso: Spondylodesis, fusionSurgical fracture stabilization with a posterior screw-rod system from C1-2 from a posterior approach. The routine surgery commonly lasts approximately 100 minutes and requires a hospital stay of about 6 days. An additional external bracing in the postoperative setting is not required. | Procedure or surgery | Surgical Group |
| External immobilization with rigid cervical collarExternal immobilization with a rigid cervical collar for 12 weeks. Compliance is monitored through patient diaries, recognizing the real-world challenges of consistent brace use. Lack of adherence is considered to reflect routine clinical practice. A typical drawback of the conservative intervention in daily practice is the absolute reliance on patient compliance to wear the collar continuously for at least 12 weeks, which poses a significant challenge to this treatment strategy. | Other | Conservative Group |
Primary outcome
Barthel Index
Time frame: Baseline to 12 weeks
Change in Barthel Index (BI) between baseline and 12 weeks thereafter
9 secondary outcomes
Change in quality of life assessed by the EuroQol 5 Dimensions (EQ-5D)
Time frame: Baseline to 12 weeks and to 6 months.
Duration of surgery
Time frame: Baseline value (time of surgery)
Duration of time per day the cervical collar is worn (patient/proxy protocol)
Time frame: Baseline to 12 weeks
Neck-Disability-Index (NDI)
Time frame: Baseline, 12 weeks and 6 months after surgery/intervention
Charlson Comorbidity Index (CCI)
Time frame: Baseline value
Union rate of fracture
Time frame: 12 weeks after surgery/intervention
Readmission to hospital
Time frame: Baseline to 12 weeks to 6 months
Cross-over rate
Time frame: Baseline to 12 weeks
Change in Visual Analogue Scale Pain (VAS)
Time frame: baseline, immediately after surgery/intervention, 12 weeks after surgery/intervention and 6 months after surgery/intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Derived from this study: PubMed 41433244Wagner A, Albrecht C, Dittmer S, Egert-Schwender S, Kehl V, Stichling R, Klatt G, Ettinger B, Hecht N, Vajkoczy P, Wengert A, Kandziora F, von der Hoh NH, Heyde CE, Hartung P, Richter M, Lenz M, Eysel P, Badke A, Blume C, Clusmann H, Walter J, Krieg S, Evangelou P, Shiban E, Dreimann M, Gembruch O, Sure U, Bettag C, Rohde V, Disch A, Bekele B, Ryang YM, Kramer A, Ringel F, Wach J, Guresir E, Meyer B, Wostrack M. Surgical versus conservative treatment of odontoid fractures in the elderly: A randomized controlled clinical study (SCORE). PLoS One. 2025 Dec 23;20(12):e0337999. doi: 10.1371/journal.pone.0337999. eCollection 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C1-2 instrumentation and External immobilization with rigid cervical collar in people with Odontoid Fracture and Elderly, run by Technical University of Munich at 16 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Wostrack, Prof. Dr. (+498941405386, Maria.wostrack@tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barthel Index (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06961578, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.