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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: University Hospital, Akershus

Current Primary Outcome: The Disabilities of the Arm, Shoulder and Hand (DASH) Score (questionnaire) Disability of the arm, shoulder and arm score (DASH score) [ Time Frame: 5 years ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Constant score (questionnaire) [ Time Frame: 5years ]
    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 [ Time Frame: 5 years ]
    Plate cutout, Nail migration, screw cutout, Reduction of Head shaft angle (HSA)/ Varus subsidence,
  • Complications [ Time Frame: 5 years ]
    Infection, Avascular necrosis, thrombosis, nerve compression or damage, Pseudoarthrosis
  • Health economy [ Time Frame: 5 years ]
    Registration of visits to doctor, physiotherapist, sick leave, re-operations


Original Secondary Outcome: Same as current

Information By: University Hospital, Akershus

Dates:
Date Received: October 17, 2016
Date Started: October 2016
Date Completion: October 2024
Last Updated: October 23, 2016
Last Verified: October 2016