Clinical Trial: The Latarjet-type Procedure Using the SEM Positioner: Using a Scan to Assess Consolidation

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

Official Title: Treatment of Chronic Anterior Shoulder Instability by a Latarjet-type Bone Block Procedure Using the SEM (Science Et Medecine) Positioning Tool: Using a Scan to Assess Consolidation and Return to Norm

Brief Summary: The main objective of this study is to evaluate, after surgery for chronic anterior shoulder instability using a Latarjet technique with positioning of the bone block via an SEM positioning tool, the value of the contribution of a shoulder scan at 3 months post surgery in the decision to return to activity early as conditioned by the quality of the bone block consolidation.

Detailed Summary:

The secondary objectives of this study are to assess:

A. the position of the block according to a shoulder scan at 3 months post-surgery

B. functional scores (Constant, Walch-Duplay) at 6 weeks, 3 and 6 months post surgery.

C. Complications: osteoarthritis, lysis of the block.

D. pain.

E. date of return to full activity.

F. patient satisfaction concerning care (visual analog scale at 6 months post-surgery).


Sponsor: Centre Hospitalier Universitaire de Nīmes

Current Primary Outcome: Did the patient return to activity at 3 months? yes/no [ Time Frame: Week 6 after inclusion, which = 3 months after surgery ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Constant score [ Time Frame: week -6 ]
  • Constant score [ Time Frame: day 0 (study inclusion) ]
  • Constant score [ Time Frame: week 6 ]
  • Constant score [ Time Frame: week 18 ]
  • Walch-Duplay score [ Time Frame: week -6 ]
  • Walch-Duplay score [ Time Frame: day 0 (study inclusion) ]
  • Walch-Duplay score [ Time Frame: week 6 ]
  • Walch-Duplay score [ Time Frame: week 18 ]
  • Presence/absence of complications [ Time Frame: day 0 (study inclusion) ]
  • Presence/absence of complications [ Time Frame: week 6 ]
  • Presence/absence of complications [ Time Frame: week 18 ]
  • Visual analog scale for pain [ Time Frame: day 0 (study inclusion) ]
  • Visual analog scale for pain [ Time Frame: week 6 ]
  • Visual analog scale for pain [ Time Frame: week 18 ]
  • Date of return to total activity [ Time Frame: week 18 ]
  • Visual analog scale for satisfaction [ Time Frame: week 18 ]


Original Secondary Outcome:

  • Constant score [ Time Frame: week -6 ]
  • Constant score [ Time Frame: day 0 (study inclusion) ]
  • Constant score [ Time Frame: week 6 ]
  • Constant score [ Time Frame: week 18 ]
  • Rowe score [ Time Frame: week -6 ]
  • Rowe score [ Time Frame: day 0 (study inclusion) ]
  • Rowe score [ Time Frame: week 6 ]
  • Rowe score [ Time Frame: week 18 ]
  • ASES score [ Time Frame: week -6 ]
  • ASES score [ Time Frame: day 0 (study inclusion) ]
  • ASES score [ Time Frame: week 6 ]
  • ASES score [ Time Frame: week 18 ]
  • Walch-Duplay score [ Time Frame: week -6 ]
  • Walch-Duplay score [ Time Frame: day 0 (study inclusion) ]
  • Walch-Duplay score [ Time Frame: week 6 ]
  • Walch-Duplay score [ Time Frame: week 18 ]
  • Presence/absence of complications [ Time Frame: day 0 (study inclusion) ]
  • Presence/absence of complications [ Time Frame: week 6 ]
  • Presence/absence of complications [ Time Frame: week 18 ]
  • Visual analog scale for pain [ Time Frame: day 0 (study inclusion) ]
  • Visual analog scale for pain [ Time Frame: week 6 ]
  • Visual analog scale for pain [ Time Frame: week 18 ]
  • Date of return to total activity [ Time Frame: week 18 ]
  • Visual analog scale for satisfaction [ Time Frame: week 18 ]


Information By: Centre Hospitalier Universitaire de Nīmes

Dates:
Date Received: April 15, 2015
Date Started: May 2016
Date Completion: February 2017
Last Updated: May 23, 2016
Last Verified: May 2016