Follow-up Study After Bankart Repair Using MG-1

Follow-up Study After Arthroscopic Bankart Repair Using MG-1 for Dislocation of Shoulder

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02228226

Enrollment

Registered

2014-08-28

Start date

2014-08-31

Completion date

2015-04-30

Last updated

2015-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Dislocation

Keywords

Arthroscopic Bankart repair, Bone hole, Ossification, Suture anchor, Shoulder dislocation

Brief summary

Long term follow-up of patients those who underwent arthroscopic Bankart repair using MG-1 for dislocation of shoulder to evaluate anchor bone hole condition and ossification.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patient who was enrolled to the clinical trial of MG-1 at Funabashi Orthopaedic Hospital and who don't withdraw the consent * Patient who understand the contents of the study and from whom a written consent can be obtained

Exclusion criteria

* Patient with dementia * Patient who cannot undergo CT examination * Patient who underwent further surgery to ipsilateral shoulder joint after the clinical trial * Patient who is pregnant or lactating * Patient judged to be inappropriate for the study by the (sub)investigator

Design outcomes

Primary

Measure	Time frame	Description
Bone Hole Condition	over 24 months after surgery	To evaluate Bone Hole Condition with score based on CT images. CT images are evaluated and scored by three evaluators who are MDs and independent of this study director. Definitions of the score are described as below. * Type 1: Opened or enlarged * Type 2: Slightly closed (\<50%) * Type 3: Almost closed (\>=50%) * Type 4: Completely closed
Ossification	over 24 months after surgery	To evaluate Ossification with score based on CT images. CT images are evaluated and scored by three evaluators who are MDs and independent of this study director. Definitions of the score are described as below. * Type 1: Little or no ossification * Type 2: Ossification fills some of the anchor site that is discontinuous or with a wide lucent rim * Type 3: Ossification fills most of the anchor site with a thin lucent rim. This area's density is consistent with cancellous bone * Type 4: Ossification fills the anchor site completely with an indistinct border between the anchor site and the adjacent cancellous bone

Secondary

Measure	Time frame	Description
Clinical Function Evaluation	over 24 months after surgery	To evaluate the Japan Shoulder Society Shoulder Instability Score (JSS-SIS) and Rowe Score at 12 weeks after surgery JSS-SIS Score (subscales are summed, higher values represent a better outcome): * Pain (0 to 20) * Function (0 to 20) * Range of Motion (0 to 20) * Evaluation of X-ray findings (0 to 10) * Stability (0 to 30) Rowe Score (subscales are summed, higher values represent a better outcome): * Stability (0 to 50) * Motion (0 to 20) * Function (0 to 30)

Countries

Japan

Outcome results