Follow-up Study After Bankart Repair Using MG-1

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Shoulder Dislocation Joint Diseases Joint Dislocations Musculoskeletal Diseases Shoulder Injuries Wounds and Injuries

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Funabashi Orthopaedic Hospital

Funabashi, Chiba, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Bone Hole Condition

Time frame: 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

Time frame: 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 outcomes

Clinical Function Evaluation

Time frame: 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)

Sponsors and collaborators

Lead sponsor

Johnson & Johnson K.K. Medical Company

Industry

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2015
First posted: Aug 28, 2014
Registry last updated: Apr 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed