Polyaxial Locking Plates in Treating Distal Humeral Fractures
Primary Purpose
Distal Humerus Fracture
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Medartis
Synthes
Sponsored by
About this trial
This is an interventional treatment trial for Distal Humerus Fracture focused on measuring locking plate, anatomical preshaped, polyaxial, outcome
Eligibility Criteria
Inclusion Criteria:
- The inclusion criteria involve all patients from the age of 18 to 95 years who suffered from a distal humeral fracture (AO 13-A1 - AO 13-C3) that had to undergo operative treatment
Exclusion Criteria:
- The exclusion criteria involve all under-aged patients (< 18 years), pregnant patients and patients with a mental disorder as well as patients under comprehensive legal support. In addition, pathological fractures had been excluded from the study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Medartis
Synthes
Arm Description
Surgery using the Medartis Implant
Surgery using the Synthes implant
Outcomes
Primary Outcome Measures
Mayo Elbow Performance Score (MEPS)
clinical and functional outcome
Secondary Outcome Measures
Full Information
NCT ID
NCT03272490
First Posted
August 31, 2017
Last Updated
September 1, 2017
Sponsor
Technical University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT03272490
Brief Title
Polyaxial Locking Plates in Treating Distal Humeral Fractures
Official Title
Polyaxial Locking Plates in Treating Distal Humeral Fractures: a Comparative Randomized Trial for Clinical Outcome
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
February 5, 2014 (Actual)
Primary Completion Date
June 6, 2017 (Actual)
Study Completion Date
July 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Technical University of Munich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
20 patients with distal humeral fractures (AO 13-A1 - AO 13-C3) were included in the current study since 2014. After completing the randomization plan, patients were distributed into two groups for different variable angle locking plates (DePuy Synthes VA-LCP vs. Medartis Aptus Elbow). Clinical and radiological follow-ups were conducted 6 weeks, 12 weeks, 6 months and 12 months after the operation.
Detailed Description
Before study initiation the approval of the local ethics committee of (Trial Number 253/14) was obtained. The clinical trial included 20 patients with fractures of the distal humerus recruited from a level-one university trauma centre. Patient recruitment was conducted between 03/2014 and 12/2015. Fractures of the distal humerus, as defined by the AO classification system (AO 13-A1 - AO 13-C3), were included in this study as they were identified by the treating surgeon being applicable for locking plate treatment and after written informed consent of the patients was obtained. All patients were randomized following a randomization plan (Randlist, DatInf GmbH, Tübingen, Germany) for either being treated with the DePuy Synthes VA-LCP 2.7/3.5 mm (DePuy Synthes, Umkirch, Germany) or with the Medartis Aptus Elbow system 2.0/3.8 mm (Medartis, Basel, Switzerland). Both systems include anatomically preshaped, polyaxial angular stable locking plates in various sizes. Angle stable screw positioning with the freedom of +/- 15° off-axis screw placement gives the surgeon a large variety in both systems.
The inclusion criteria involve all patients from the age of 18 to 95 years who suffered from a distal humeral fracture (AO 13-A1 - AO 13-C3) that had to undergo operative treatment. The exclusion criteria involve all under-aged patients (< 18 years), pregnant patients and patients with a mental disorder as well as patients under comprehensive legal support. In addition, pathological fractures had been excluded from the study.
Surgical technique
All patients were operated by experienced upper extremity surgeons. The mean interval between injury and operation was 2.4 days (range 0-12 days). General anaesthesia was used in all cases and a single dose of 1.5 mg cephalosporin was given preoperatively for prophylaxis. Patients were positioned in prone position with the injured arm on a radiolucent, small padded arm holder. Under tourniquet control, the posterior approach (Bryan-Morrey) to the distal humerus was performed in all cases. Additional olecranon osteotomy was performed in 7 cases (3x DePuy Synthes vs. 4x Medartis Aptus Elbow) presenting with AO type 13 C2 and AO type 13 C3 fractures. Postoperatively, physiotherapy was initiated using the same rehabilitation protocol for both groups. Passive and active assisted ROM was permitted immediately without limitations, while weight bearing was restricted for 6 weeks.
Follow-up evaluation
All patients were initially followed-up 6 weeks after operation. Additional follow-ups were performed 3, 6 and 12 months postoperatively. The follow-up examinations were carried out by an independent investigator not involved in patient´s initial surgical treatment (MC). After the assessment of pain using the visual analogue scale (VAS) was documented, ROM and collateral ligament stability were documented on standardized scoring sheets. For subjective evaluation, patients rated their satisfaction for elbow use on a scale of 1 to 6 (1-highly satisfied; 2-satisfied; 3-moderate; 4-sufficient; 5-unsatisfied; 6-very unsatisfied). Moreover, sensomotoric disturbances and postoperative complications were recorded. For functional upper extremity and elbow scoring the shortened Disabilities of the Arm, Shoulder and Hand Score (QuickDASH) and the Mayo Elbow Performance Score (MEPS) were comprised. Postoperative x-rays were evaluated with special respect to bony healing, secondary loss of reduction and heterotopic ossifications.
Statistics
Statistical analyses were performed using the statistical software SigmaStat (version 3.5; Systat Software, San Jose, CA, USA). The scores at certain time points were compared with an independent t test after a normality check had been passed and equal variances had been detected. Normal distributed data with unequal variances would have been compared with Welch's t test. Arbitrarily data was tested with Mann-Whitney U test. The significance level was set at p= 0.05.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Humerus Fracture
Keywords
locking plate, anatomical preshaped, polyaxial, outcome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Medartis
Arm Type
Active Comparator
Arm Description
Surgery using the Medartis Implant
Arm Title
Synthes
Arm Type
Active Comparator
Arm Description
Surgery using the Synthes implant
Intervention Type
Procedure
Intervention Name(s)
Medartis
Intervention Description
Surgery using the medartis implant
Intervention Type
Procedure
Intervention Name(s)
Synthes
Intervention Description
Surgery using the Synthes implant
Primary Outcome Measure Information:
Title
Mayo Elbow Performance Score (MEPS)
Description
clinical and functional outcome
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The inclusion criteria involve all patients from the age of 18 to 95 years who suffered from a distal humeral fracture (AO 13-A1 - AO 13-C3) that had to undergo operative treatment
Exclusion Criteria:
The exclusion criteria involve all under-aged patients (< 18 years), pregnant patients and patients with a mental disorder as well as patients under comprehensive legal support. In addition, pathological fractures had been excluded from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Bibethaler, Prof.
Organizational Affiliation
Department of Trauma Surgery Klinikum rechts der Isar Technical University of Munich, Germany Ismaninger Strasse 22 81675 Munich, Germany
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29282027
Citation
Cronlein M, Lucke M, Beirer M, Pforringer D, Kirchhoff C, Biberthaler P, Braun KF, Siebenlist S. Polyaxial locking plates in treating distal humeral fractures: a comparative randomized trial for clinical outcome. BMC Musculoskelet Disord. 2017 Dec 28;18(1):547. doi: 10.1186/s12891-017-1910-9.
Results Reference
derived
Learn more about this trial
Polyaxial Locking Plates in Treating Distal Humeral Fractures
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