Longterm Outcome of the Delta III Inverse Prosthesis

Rotator Cuff Tear Arthropathy Clinical Trial

Official title:

The Reverse Delta III Total Shoulder Prosthesis - Longerm Results in 98 Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01873651
• Other study ID #: Delta III
• Status: Withdrawn
• Phase: Phase 4
• First received: June 5, 2013
• Last updated: August 8, 2014
• Start date: October 2013
• Est. completion date: March 2014

Study information

• Verified date: August 2014
• Source: Schulthess Klinik
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to describe the results after > 10 years due to a prosthesis implant.

Description:

The aim of the study is to measure the gain of the benefit in function an painreduction which the patient yields with this type of prosthesis in a longterm (> 10 years )outcome. Additionally the long-term results will be compared with the mid-term results and the literature. Furthermore the complications since the mid-term measurement time point will be determined.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• implantation of a Delta III - prothesis

• timeframe (Oct 1998 - Dec 2002)

• delta-pectoral approach

• written informed consent

Exclusion Criteria:

• Implantation because of a revision

• Complaints, which make it difficult to follow instructions or even prevent

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rotator Cuff Tear Arthropathy

Intervention

Device:
• Implantation of a Delta III Prosthesis
Implantation of a Delta III Prosthesis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Schulthess Klinik

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Constant Murley Score		10 years	No
Secondary	cASES		10 years	No
Secondary	pASES		10 years	No
Secondary	SF-36		10 years	No
Secondary	DASH-Questionannaire		10 years	No
Secondary	SPADI		10 years	No
Secondary	x-ray (Sperling Classification)		10 years	No
Secondary	x-ray (Sirveaux Classification)		10 years	No
Secondary	Description of the glenoid	Description of the situation: e.g.; any dissociation of the gleonid; any migration of the glenoid	10 years	No
Secondary	Description of the stem	Description of the situation: e.g.; - change of the position	10 years	No