Pegs for Osteofixation of Proximal Humeral Fractures

• Sponsor: Oslo University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04622852
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Actual Duration (Months): 49
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

Patients treated operative for Proximal humeral fractures with angular stable device (Philos plate or ALPS-PHP)

Condition or Disease	Intervention/Treatment	Phase
Implant Complication; Proximal Humeral Fracture; Avascular Necrosis of Humerus	Device: Open reduction internal fixation (ORIF) with an angular stable plate

Detailed Description

From a cohort of patients treated for displaced Proximal humeral fractures (PHF) in the period July 2017 - August 2019 patients with the 11-B2 and 11-C2 PHF according to AO/OTA 2007 fracture classification were selected according to age and gender to be compared with patients operated with a Philos plate within the same fracture group, age and gender to be matched for adverse events:

1. Radiographic evidence of penetration of pegs (ALPS-PHP) or screws (Philos) into the glenohumeral joint (primary outcome) and

2. Avascular head necrosis / sinking / need of re-surgery

3. Clinical PROMS

Study Design

• Study Type: Observational
• Actual Enrollment: 38 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Are Pegs Better Than Screw for Osteofixation of Proximal Humeral Fractures?
• Actual Study Start Date: Jul 1, 2017
• Actual Primary Completion Date: Sep 1, 2020
• Actual Study Completion Date: Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Group A: ALPS-PHP device Patients operated with angular stable plate for displaced PHF with an ALPS plate	Device: Open reduction internal fixation (ORIF) with an angular stable plate; Operative treatment of proximal humeral fracture
Group B: Philos device Patients operated with angular stable plate for displaced PHF with a Philos plate	Device: Open reduction internal fixation (ORIF) with an angular stable plate; Operative treatment of proximal humeral fracture

Outcome Measures

Primary Outcome Measures

1. Peg penetration into glenohumeral joint [12 months]

   Radiographic or CT verified peg penetration

2. Screw penetration into glenohumeral joint [12 months]

   Radiographic or CT verified screw penetration

Secondary Outcome Measures

1. Humeral head deformation [12 months]

   Avascular head necrosis or Sinking

2. Shoulder function [12 months]

   Constant-Murley score

3. Self reported shoulder function [12 months]

   Oxford scoulder score

4. Quality of life [12 months]

   Generic 15D score

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criterion:

• Acute proximal humeral fracture

• AO/OTA type 11-B2 or 11C2

Exclusion Criteria:

• Not eligible to surgical treatment

• Non-compliant

• Former shoulder fracture or symptomatic shoulder illness

• Drug abuser

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oslo University Hospital	Oslo		Norway

Sponsors and Collaborators

• Oslo University Hospital

Investigators

• Principal Investigator: Tore Fjalestad, MD, PhD., Oslo University Hospital, Ortophaedic Dept.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tore Fjalestad, MD. PhD. Senior Consultant Ortophaedic Surgeon, Oslo University Hospital
• ClinicalTrials.gov Identifier: NCT04622852
• Other Study ID Numbers: 2017/681
• First Posted: Nov 10, 2020
• Last Update Posted: Sep 14, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Tore Fjalestad, MD. PhD. Senior Consultant Ortophaedic Surgeon, Oslo University Hospital: Humeral head; Screw penetration; Peg penetration; Avascular necrosis
• Additional relevant MeSH terms: Necrosis; Fractures, Bone; Humeral Fractures; Shoulder Fractures

Study Results

No Results Posted as of Sep 14, 2021