Accuracy Evaluation of Shoulder Replacement Surgery

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Balgrist University Hospital
Sponsor:
Information provided by (Responsible Party):
Lazaros Vlachopoulos, MD, Balgrist University Hospital
ClinicalTrials.gov Identifier:
NCT02052206
First received: January 30, 2014
Last updated: January 31, 2014
Last verified: January 2014
  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: 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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Assessment of the clinical outcome

  • Subjective shoulder value [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Constant score [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: March 2014
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2016 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02052206

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

Locations
Switzerland
University Hospital Balgrist Not yet 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

No publications provided

Responsible Party: Lazaros Vlachopoulos, MD, MD, Balgrist University Hospital
ClinicalTrials.gov Identifier: NCT02052206     History of Changes
Other Study ID Numbers: BalgristUH_CARD_03
Study First Received: January 30, 2014
Last Updated: January 31, 2014
Health Authority: Switzerland: Ethikkommission

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

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

ClinicalTrials.gov processed this record on September 18, 2014