Targon PH+ Follow-Up

• ClinicalTrials.gov Identifier: NCT02836366
• Recruitment Status: Completed
• First Posted: July 19, 2016
• Last Update Posted: June 7, 2019
• Sponsor: Aesculap AG
• Information provided by (Responsible Party): Aesculap AG

Study Description

Brief Summary:

With this study results of the Targon® PH+ nail, developed for the treatment of humeral head fractures, will be investigated clinically, radiological evaluation is optional. The primary objective of this study is to examine the effect of a plating treatment on the speed of recovery of functional capacity in adult patients. Secondary aims are to examine the level of pain, patient satisfaction, shoulder function, quality of life, radiological evaluation and complications.

Targon PH+ is CE certified. The study is a non-interventional cohort study sponsored by Aesculap

Condition or disease
Shoulder Fractures

Study Design

• Study Type: Observational
• Actual Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prospective Cohort Study of Proximal Humeral Fractures Treated With Targon® PH+
• Actual Study Start Date: March 2016
• Actual Primary Completion Date: April 2019
• Actual Study Completion Date: April 2019

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Functional Capacity [ Time Frame: 24 months ]
   The DASH score (Disabilities of the Arm, Shoulder, and Hand) will be used to determine the recovery of functional capacity. It provides a summary of the responses on a scale of 0 (no disability) to 100 (severe disability)

Secondary Outcome Measures :

1. Level of pain [ Time Frame: 3, 12 and 24 months ]
   10-point Visual Analogue Scale (VAS) from no pain (0) to most extreme pain imaginable (10)
2. Patient satisfaction [ Time Frame: 24 months ]
   4 point scale: very satisfied, satisfied, unsatisfied, very unsatisfied
3. Shoulder Function [ Time Frame: 12 months, 24 months ]
   Shoulder function outcome is measured with the Constant-Murley score, this score system combines shoulder function tests (65 points) with a subjective evaluation of the patients (35 points) including activities of daily living, level of work
4. Radiological outcome (only if it could be raised in clinical standard) [ Time Frame: 24 months ]
   The X-rays are examined regarding adverse events as screw perforation, screw breakage, cut-out, re-dislocation of the fracture
5. Adverse Events [ Time Frame: 24 months ]
   Rate of Adverse Events, for example secondary interventions (revisions) that occur within the follow-up period

Eligibility Criteria

• Ages Eligible for Study: 60 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

adult patients

Criteria

Inclusion Criteria: - patients with a three- or four-fragment-fracture of the proximal humerus, with dislocation on X-ray

• older than 60 years of age
• written and signed patient consent

Exclusion Criteria: - Fractures more than 14 days old

• multiple comorbidity
• multitrauma (Injury Severity Score > 15)
• prev. surgery on the injured shoulder
• severely deranged function caused by a previous disease head-split proximal humerus fracture
• combined humerus head and shaft fractures
• pseudarthroses
• crushed head cap of the humerus head (AO 11 C3 fractures)
• isolated avulsion fracture of a tuberosity
• unwillingness or inability to follow protocol instructions and study requirements (follow-up visits)
• no signed informed consent
• treatment not in line with Instructions for Use (IfU)

Contacts and Locations

Locations

Germany

Klinikum Nürnberg Süd

Nürnberg, Bayern, Germany, 90471

Sponsors and Collaborators

Aesculap AG

Investigators

• Principal Investigator: Hermann Josef Bail, Prof. Dr.; Klinikum Nürnberg Süd

More Information

• Responsible Party: Aesculap AG
• ClinicalTrials.gov Identifier: NCT02836366
• Other Study ID Numbers: AAG-O-H-1536
• First Posted: July 19, 2016
• Last Update Posted: June 7, 2019
• Last Verified: June 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Aesculap AG:

Proximal humerus; Fracture; Nailing

Additional relevant MeSH terms:

Fractures, Bone; Shoulder Fractures; Wounds and Injuries; Shoulder Injuries