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Accuracy Evaluation of Shoulder Replacement Surgery

This study is currently recruiting participants.
Verified July 2017 by Lazaros Vlachopoulos, MD, Balgrist University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02052206
First Posted: February 3, 2014
Last Update Posted: July 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Lazaros Vlachopoulos, MD, Balgrist University Hospital
  Purpose
The purpose of this study is to evaluate the accuracy of shoulder replacement surgery in realization a computer assisted 3D planning compared to conventional 2D planning.

Condition Intervention
Osteoarthritis of the Shoulder Complexe Proximal Humeral Fractures Procedure: Shoulder replacement surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Accuracy Evaluation of Shoulder Replacement Surgery With Computer-assisted 3D Planning

Resource links provided by NLM:


Further study details as provided by Lazaros Vlachopoulos, MD, Balgrist University Hospital:

Primary Outcome Measures:
  • Quantitative analysis of the discrepancy (difference of translation in mm and rotation in degrees) in the realized position of the components compared to the preoperative planning [ Time Frame: 6 weeks ]
    The deviation of the realized position of the artificial joint components will be quantified by overlay of the preoperative planning and a 3D model of the postoperative position of the shoulder replacement acquired from CT scans.


Secondary Outcome Measures:
  • Clinical outcome [ Time Frame: 1 year ]
    Assessment of the clinical outcome

  • Subjective shoulder value [ Time Frame: 1 year ]
  • Constant score [ Time Frame: 1 year ]

Estimated Enrollment: 80
Study Start Date: March 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Computer-assisted 3D planning
Realization of the shoulder replacement according to the computer-assisted 3D preoperative plan
Procedure: Shoulder replacement surgery
Active Comparator: Conventional 2D planning
Realization of the shoulder replacement according to the 2D preoperative plan
Procedure: Shoulder replacement surgery

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • osteoarthritis or complexe proximal humeral fracture and indication for shoulder arthroplasty
  • patients > 18years

Exclusion Criteria:

  • contraindication for computertomography
  • pregnancy
  • previous fracture or shoulder replacement of the contralateral side in case of a complexe proximal humeral fracture
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02052206


Contacts
Contact: Lazaros Vlachopoulos, MD 0041 44 386 5747 lvlachopoulos@card.balgrist.ch

Locations
Switzerland
University Hospital Balgrist Recruiting
Zurich, Switzerland
Principal Investigator: Christian Gerber, Prof.         
Principal Investigator: Dominik Meyer, Prof.         
Principal Investigator: Lazaros Vlachopoulos, MD         
Sponsors and Collaborators
Balgrist University Hospital
Investigators
Study Chair: Lazaros Vlachopoulos, MD Balgrist University Hospital
  More Information

Responsible Party: Lazaros Vlachopoulos, MD, MD, Balgrist University Hospital
ClinicalTrials.gov Identifier: NCT02052206     History of Changes
Other Study ID Numbers: BalgristUH_CARD_03
First Submitted: January 30, 2014
First Posted: February 3, 2014
Last Update Posted: July 13, 2017
Last Verified: July 2017

Keywords provided by Lazaros Vlachopoulos, MD, Balgrist University Hospital:
osteoarthritis
complexe proximal humeral fracture
shoulder
shoulder replacement
accuracy
computer-assisted
3D

Additional relevant MeSH terms:
Shoulder Fractures
Shoulder Injuries
Osteoarthritis
Humeral Fractures
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Arm Injuries
Wounds and Injuries
Fractures, Bone