Proximal Humeral FractureDeltaConNCT03531463
The Nordic DeltaCon Trial for Displaced Proximal Humeral Fractures in Elderly
A study testing Operative treatment with Reversed Total Shoulder Prosthesis in people with Proximal Humeral Fracture, run by Oslo University Hospital at 3 sites in 3 countries.
Trial summary
The Nordic DeltaCon Trial is a prospective, single-blinded, randomized, controlled, multi-center and multi-national trial comparing reverse prosthesis and non-operative treatment in displaced proximal humerus fractures, in the elderly patients aged 65 to 85 years with displaced OTA/AO group B2 or C2 fractures… Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Proximal Humeral Fracture
- What is being tested?
- Operative treatment with Reversed Total Shoulder Prosthesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Oct 2018to 10 Dec 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Low energy AO/OTA group 11-B1.1, 11-B1.2 and 11-C1.1, 11-C3.1. Both B and C type includes subgroups: Displaced [2], Impacted [3] or Non impacted [4] from the universal modifiers list.
Who cannot join
- Radiographic Mal-inclination Less than; varus 30°or valgus 45° Less than 50% contact between head fragment and meta-/diaphysis Head split fractures with more than 10% of the articular surface in the main head fragment.
- Head split fractures (group 11-C3.2 and 11-C3.3) with more than 10% of the articular surface in the main head fragment.
- Dislocation or fracture-dislocation of the gleno-humeral joint Pathological fracture
- General
- Refuse to participate
- Age under 65 years of age, or over 85 years of age
Show all 12Show fewer
- Serious poly-trauma or additional surgery
- Non-independent, drug/alcohol abuse or institutionalized (low co-operation)
- Contra-indications for surgery
- Does not understand written and spoken guidance in local languages
- Previous fracture with symptomatic sequelae in either shoulder
- Patients living outside the hospital's catchment area
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Nordic DeltaCon Trial: Non-operative Treatment Versus Reversed Total Shoulder Prosthesis in Patients Sixty Five Years of Age and Older With Displaced 3- and 4 Parts Proximal Humeral Fractures - a Prospective, Randomized Controlled Trial
The Nordic DeltaCon Trial is a prospective, single-blinded, randomized, controlled, multi-center and multi-national trial comparing reverse prosthesis and non-operative treatment in displaced proximal humerus fractures, in the elderly patients aged 65 to 85 years with displaced OTA/AO group B2 or C2 fractures (According to the new 2018 revision: AO/OTA (Orthopaedic Trauma Association) group 11-B1.1, 11-B1.2 and 11-C1.1, 11-C3.1. )
Read the detailed description
Single-blinded, multi-center, multi-national (Finland, Sweden, Denmark, Norway) Primary outcome in this study is QuickDASH (The short form of Disabilities of the arm, shoulder and hand) score measured at two years.
Secondary outcomes are QuickDASH at/after one, two (short term) and five years (medium term), general visual analog scale (VAS) for pain, Oxford shoulder score (OSS), Constant-score (CS), number of re-operations and complications. Quality of life is assessed with 15-D. Cost-effectiveness analysis will be performed after completion of the trial.
In addition to 2 years main outcome (short term) follow-up will continue to 5 years (medium term) and 10 years (long term). The power calculation is based on 2 years.
- Conditions
- Proximal Humeral Fracture
- Being tested
- Operative treatment with Reversed Total Shoulder Prosthesis
- Keywords
- Displaced, Non-Operative treatment, Reversed Total Shoulder Prosthesis
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operative treatment with Reversed Total Shoulder ProsthesisProcedure or surgery
The standardized approach is the delto-pectoral to minimize any damage of the deltoid muscle. A cemented monoblock humeral stem will be implanted. Braided polyester suture-cerclages engaging the insertion of the subscapular and infraspinatus tendons enforced by a bonegraft or a "horseshoe-graft" from the humeral head will be used
| Study group | Role | What they receive |
|---|---|---|
| Operative treatment | Active comparator | Operative treatment of the displaced proximal humeral fracture with a reversed total shoulder prothesis (Delta prosthesis) using a stadardized deltopectoral approach, bone block grafting and thread cerclages of the tubercles.
Rehabilitation with standardized physiotherapy guideline and self exercise protocol Receives: Procedure: Operative treatment with Reversed Total Shoulder Prosthesis |
| Non-Operative treatment | No intervention | Rehabilitation with standardized physiotherapy guideline and self exercise protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quick-DASH
The short form of Disabilities of the arm, shoulder and hand
Measured: From enrollment to 5 years follow-up. Scale 1-4 points (Total point x answers given) x25. Lowest point best
Secondary outcomes (6)
Oxford Shoulder Score
Shoulder specific patient self-assesment
Measured: From enrollment to 5 years follow-up. Scale 0 - 48, lowest score best.
15 D Quality of Life
15 Questions 5 levels Generic Score (Harri Sintonen)
Measured: From enrollemtn to 5 years follow-up. 15 questions, 5 levels, scale 0.000 - 1.000. Highest number best.
Constant score (CS)
Functional outcome for the shoulder
Measured: From enrollment to 5 years follow-up. Scale 0- 100 points. Highest best if only actual shoulder is scored..
VAS pain
General visual analog scale (VAS) for pain
Measured: From enrollement to 5 eyars follow-up. Scale 0-15 points, best equal zero points
Radiographic + Computer Tomography scan (CT)
Plain radiographs 2 plane (true front + scapula Y view) and CT of injured shoulder
Measured: From enrollemnt to 5 years follow-up for plain radiographs. CT at enrollement and at 2 years.
Patient involvement
The aim of the interviews will be to move towards patient-centered medicine by taking into account the goals, preferences and values of patients
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start1 Oct 2018
- Primary completion10 Dec 2023
- Study completion10 Dec 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 Proximal Humeral FractureStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Randomized controlled single-blinded trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University Hospital
- Responsible party
- Principal investigator, Tore Fjalestad, Oslo University Hospital
- Investigators
- Ville Mattila, Professor, Study chair, Professor in orthopedics and traumatology, Tampere University Chief of musculoskeletal department, Tampere University Hospital Visiting professor, Karolinska Institute, Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531463
- Sponsor's protocol ID
- 2018/476-D
- Acronym
- DeltaCon
- Status last verified
- Dec 2025
- First submitted
- 27 Apr 2018
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Launonen AP, Fjalestad T, Laitinen MK, Lahdeoja T, Ekholm C, Wagle T, Mattila VM; NITEP-group. Nordic Innovative Trials to Evaluate osteoPorotic Fractures (NITEP) Collaboration: The Nordic DeltaCon Trial protocol-non-operative treatment versus reversed total shoulder arthroplasty in patients 65 years of age and older with a displaced proximal humerus fracture: a prospective, randomised controlled trial. BMJ Open. 2019 Jan 29;9(1):e024916. doi: 10.1136/bmjopen-2018-024916.
PubMed 30700485
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nordic DeltaCon Trial: Non-operative Treatment Versus Reversed Total Shoulder Prosthesis in Patients Sixty Five Years of Age and Older With Displaced 3- and 4 Parts Proximal Humeral Fractures - a Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03531463
- Acronym / sponsor ID
- DeltaCon / 2018/476-D
- Conditions
- Proximal Humeral Fracture
- Keywords
- Displaced, Non-Operative treatment, Reversed Total Shoulder Prosthesis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Tampere University Hospital
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 10 Dec 2023 (actual)
- Study completion
- 10 Dec 2028 (estimated)
- First posted
- 21 May 2018 (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 Nordic DeltaCon Trial is a prospective, single-blinded, randomized, controlled, multi-center and multi-national trial comparing reverse prosthesis and non-operative treatment in displaced proximal humerus fractures, in the elderly patients aged 65 to 85 years with displaced OTA/AO group B2 or C2 fractures (According to the new 2018 revision: AO/OTA (Orthopaedic Trauma Association) group 11-B1.1, 11-B1.2 and 11-C1.1, 11-C3.1. )
Detailed description
Single-blinded, multi-center, multi-national (Finland, Sweden, Denmark, Norway) Primary outcome in this study is QuickDASH (The short form of Disabilities of the arm, shoulder and hand) score measured at two years.
Secondary outcomes are QuickDASH at/after one, two (short term) and five years (medium term), general visual analog scale (VAS) for pain, Oxford shoulder score (OSS), Constant-score (CS), number of re-operations and complications. Quality of life is assessed with 15-D. Cost-effectiveness analysis will be performed after completion of the trial.
In addition to 2 years main outcome (short term) follow-up will continue to 5 years (medium term) and 10 years (long term). The power calculation is based on 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled single-blinded trial
| Arm | Type | Receives |
|---|---|---|
| Operative treatment | Active comparator | Procedure: Operative treatment with Reversed Total Shoulder ProsthesisOperative treatment of the displaced proximal humeral fracture with a reversed total shoulder prothesis (Delta prosthesis) using a stadardized deltopectoral approach, bone block grafting and thread cerclages of the tubercles. Rehabilitation with standardized physiotherapy guideline and self exercise protocol |
| Non-Operative treatment | No intervention | –Rehabilitation with standardized physiotherapy guideline and self exercise protocol |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Low energy AO/OTA group 11-B1.1, 11-B1.2 and 11-C1.1, 11-C3.1. Both B and C type includes subgroups: Displaced [2], Impacted [3] or Non impacted [4] from the universal modifiers list.
Key exclusion criteria (12 listed)
- Radiographic Mal-inclination Less than; varus 30°or valgus 45° Less than 50% contact between head fragment and meta-/diaphysis Head split fractures with more than 10% of the articular surface in the main head fragment.
- Head split fractures (group 11-C3.2 and 11-C3.3) with more than 10% of the articular surface in the main head fragment.
- Dislocation or fracture-dislocation of the gleno-humeral joint Pathological fracture
- General
- Refuse to participate
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 |
|---|---|---|
| Operative treatment with Reversed Total Shoulder ProsthesisThe standardized approach is the delto-pectoral to minimize any damage of the deltoid muscle. A cemented monoblock humeral stem will be implanted. Braided polyester suture-cerclages engaging the insertion of the subscapular and infraspinatus tendons enforced by a bonegraft or a "horseshoe-graft" from the humeral head will be used | Procedure or surgery | Operative treatment |
Primary outcome
Quick-DASH
Time frame: From enrollment to 5 years follow-up. Scale 1-4 points (Total point x answers given) x25. Lowest point best
The short form of Disabilities of the arm, shoulder and hand
6 secondary outcomes
Oxford Shoulder Score
Time frame: From enrollment to 5 years follow-up. Scale 0 - 48, lowest score best.
15 D Quality of Life
Time frame: From enrollemtn to 5 years follow-up. 15 questions, 5 levels, scale 0.000 - 1.000. Highest number best.
Constant score (CS)
Time frame: From enrollment to 5 years follow-up. Scale 0- 100 points. Highest best if only actual shoulder is scored..
VAS pain
Time frame: From enrollement to 5 eyars follow-up. Scale 0-15 points, best equal zero points
Radiographic + Computer Tomography scan (CT)
Time frame: From enrollemnt to 5 years follow-up for plain radiographs. CT at enrollement and at 2 years.
Patient involvement
Time frame: 2 years
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 Jan 2026.
- Background: PubMed 30700485Launonen AP, Fjalestad T, Laitinen MK, Lahdeoja T, Ekholm C, Wagle T, Mattila VM; NITEP-group. Nordic Innovative Trials to Evaluate osteoPorotic Fractures (NITEP) Collaboration: The Nordic DeltaCon Trial protocol-non-operative treatment versus reversed total shoulder arthroplasty in patients 65 years of age and older with a displaced proximal humerus fracture: a prospective, randomised controlled trial. BMJ Open. 2019 Jan 29;9(1):e024916. doi: 10.1136/bmjopen-2018-024916.
- Trial website for patients, their relatives and health workersLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Ville Mattila, Professor study chair
Professor in orthopedics and traumatology, Tampere University Chief of musculoskeletal department, Tampere University Hospital Visiting professor, Karolinska Institute, Stockholm
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Operative treatment with Reversed Total Shoulder Prosthesis in people with Proximal Humeral Fracture, run by Oslo University Hospital at 3 sites in 3 countries.
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 1 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark, Finland, Norway. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quick-DASH (time frame: From enrollment to 5 years follow-up. Scale 1-4 points (Total point x answers given) x25. Lowest point best). 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 NCT03531463, 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 Jan 2026.