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Plate Fixation Versus Intramedullary Nailing of 3 and 4 Part Proximal Humerus Fractures

Primary Purpose

Shoulder Fractures, Humeral Fractures, Proximal

Status

Active

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Multiloc nail

Philos plate

About this trial

This is an interventional treatment trial for Shoulder Fractures focused on measuring Multiloc, Philos, Locking plate, Straight nail, Randomized controlled trial, 3 and 4 part fractures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients > 18 years
Severe displacement, defined as malposition of at least 45⁰ of angular deviation in valgus or 30⁰ in varus in true frontal projection, regardless of whether the fracture is impacted or not. Fractures with more than 50% displacement of the head against the surgical neck
The greater or lesser tubercles must be fractured in a 3 or 4-part fracture. The degree of displacement is not critical for inclusion.

Exclusion Criteria:

Exclusion criteria:

Fracture more than 3 weeks' old
Caput humeri just a thin shell or split
Ipsilateral damage that will influence the recovery and scoring systems
Incapability to protect osteosynthesis, i.e. use of crutches because of injury to lower extremity.
Pathological fracture
Neurovascular injury
Open fracture
Noncompliance
Congenital anomaly
Ongoing infectious process around the incision site for plate osteosynthesis
Systemic disease that may influence healing processes or scoring systems (RA/MS)
Fracture dislocation
Substance abuse
Inability to read and understand Norwegian
Patients not residing in our catchment area
Patients with too small humerus diameter to use a nail
Patient not able to commit and understand written consent

Sites / Locations

Akershus University hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Philos plate

Multiloc nail

Arm Description

Intervention is surgery with Philos plate

Intervention is surgery with Multiloc nail

Outcomes

Primary Outcome Measures

The Disabilities of the Arm, Shoulder and Hand (DASH) Score (questionnaire) Disability of the arm, shoulder and arm score (DASH score)

Quick Dash (questionnaire) the first 6 weeks after surgery, then DASH score (questionnaire for patients to fill out) in follow ups

Secondary Outcome Measures

Constant score (questionnaire)

A questionnaire for the doctor or the physiotherapist to fill out, including registration of: Pain, Power, Range of motion and ADL (x/100, where 100 is best score)

Radiological complications

Plate cutout, Nail migration, screw cutout, Reduction of Head shaft angle (HSA)/ Varus subsidence,

Complications

Infection, Avascular necrosis, thrombosis, nerve compression or damage, Pseudoarthrosis

Health economy

Registration of visits to doctor, physiotherapist, sick leave, re-operations

Full Information

NCT ID

NCT02944058

First Posted

October 17, 2016

Last Updated

August 14, 2023

Sponsor

University Hospital, Akershus

1. Study Identification

Unique Protocol Identification Number

NCT02944058

Brief Title

Plate Fixation Versus Intramedullary Nailing of 3 and 4 Part Proximal Humerus Fractures

Official Title

Plate Fixation Versus Intramedullary Nailing of 3 and 4 Part Proximal Humerus Fractures. A RCT

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 2016 (Actual)

Primary Completion Date

October 24, 2023 (Anticipated)

Study Completion Date

October 25, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital, Akershus

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of the project is to compare the management of 3 and 4 part proximal humerus fractures (PHF) with an angular stable plate (Philos) with that of an intramedullary nail (Multiloc) in light of complications, radiological, economical, functional and clinical outcome.

Detailed Description

Randomized controlled trial (RCT) from Akershus University Hospital in Norway. Randomization between two implants. The investigators will use deltopectoral or deltoid split as surgical access. All patients will have calcar screws and cuff sutures. When lack of bone for example after decompressing valgus compressed fractures, a bone-substitute might be used in the surgeons preference. Follow up in outpatient clinic at 6, 12, 52 and 104 weeks, but also a 5 year follow up is planned. Postoperative radiographs of both shoulders and CT of operated shoulder will be taken.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Shoulder Fractures, Humeral Fractures, Proximal

Keywords

Multiloc, Philos, Locking plate, Straight nail, Randomized controlled trial, 3 and 4 part fractures

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

79 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Philos plate

Arm Type

Active Comparator

Arm Description

Intervention is surgery with Philos plate

Arm Title

Multiloc nail

Arm Type

Active Comparator

Arm Description

Intervention is surgery with Multiloc nail

Intervention Type

Procedure

Intervention Name(s)

Multiloc nail

Intervention Description

Intervention is surgery with Multiloc nail

Intervention Type

Procedure

Intervention Name(s)

Philos plate

Intervention Description

Intervention is surgery with Philos plate

Primary Outcome Measure Information:

Title

The Disabilities of the Arm, Shoulder and Hand (DASH) Score (questionnaire) Disability of the arm, shoulder and arm score (DASH score)

Description

Quick Dash (questionnaire) the first 6 weeks after surgery, then DASH score (questionnaire for patients to fill out) in follow ups

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Constant score (questionnaire)

Description

A questionnaire for the doctor or the physiotherapist to fill out, including registration of: Pain, Power, Range of motion and ADL (x/100, where 100 is best score)

Time Frame

5years

Title

Radiological complications

Description

Plate cutout, Nail migration, screw cutout, Reduction of Head shaft angle (HSA)/ Varus subsidence,

Time Frame

5 years

Title

Complications

Description

Infection, Avascular necrosis, thrombosis, nerve compression or damage, Pseudoarthrosis

Time Frame

5 years

Title

Health economy

Description

Registration of visits to doctor, physiotherapist, sick leave, re-operations

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients > 18 years Severe displacement, defined as malposition of at least 45⁰ of angular deviation in valgus or 30⁰ in varus in true frontal projection, regardless of whether the fracture is impacted or not. Fractures with more than 50% displacement of the head against the surgical neck The greater or lesser tubercles must be fractured in a 3 or 4-part fracture. The degree of displacement is not critical for inclusion. Exclusion Criteria: Exclusion criteria: Fracture more than 3 weeks' old Caput humeri just a thin shell or split Ipsilateral damage that will influence the recovery and scoring systems Incapability to protect osteosynthesis, i.e. use of crutches because of injury to lower extremity. Pathological fracture Neurovascular injury Open fracture Noncompliance Congenital anomaly Ongoing infectious process around the incision site for plate osteosynthesis Systemic disease that may influence healing processes or scoring systems (RA/MS) Fracture dislocation Substance abuse Inability to read and understand Norwegian Patients not residing in our catchment area Patients with too small humerus diameter to use a nail Patient not able to commit and understand written consent

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Asbjorn AAroen, PhD MD

Organizational Affiliation

Akershus University Hospital, orthopedic unit

Official's Role

Study Director

Facility Information:

Facility Name

Akershus University hospital

City

Lørenskog

ZIP/Postal Code

1478

Country

Norway

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

De-identified individual participant data for all primary and secondary outcome measures will be made available within 6 months of study completion

Citations:

PubMed Identifier

35727196

Citation

Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.

Results Reference

derived

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Plate Fixation Versus Intramedullary Nailing of 3 and 4 Part Proximal Humerus Fractures

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