Can Secondary Total Elbow Arthroplasty After Failed Internal Fixation or Non-operative Treatment of Distal Humeral Fractures Achieve Equal Results as Primary Arthroplasty?

Elbow Fracture Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03302533
• Other study ID #: 001-2017
• Status: Completed
• Phase: N/A
• First received: September 30, 2017
• Last updated: October 4, 2017
• Start date: January 21, 2013
• Est. completion date: March 31, 2017

Study information

• Verified date: October 2017
• Source: Diakoniekrankenhaus Friederikenstift
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Total elbow arthroplasty (TEA) results in immediate pain release with good functional results after distal humerus fractures. But still open reduction and internal fixation is recommended as treatment of choise due to a lifelong loading limitiation, unknown implant survival and problematic revision surgery after TEA. The purpose of this study was to compare functional results and complication rates after primary total elbow arthroplasty (TEA) and TEA after failed reconstruction or non-operative treatment (secondary TEA) in the treatment of distal humerus fractures. We hypothesised that clinical and functional results are better for primary TEA with less complications.

Description:

Total elbow arthroplasty (TEA) results in immediate pain release with good functional results after distal humerus fractures. But still open reduction and internal fixation is recommended as treatment of choise due to a lifelong loading limitiation, unknown implant survival and problematic revision surgery after TEA. The purpose of this study was to compare functional results and complication rates after primary total elbow arthroplasty (TEA) and TEA after failed reconstruction or non-operative treatment (secondary TEA) in the treatment of distal humerus fractures.

This retrospective study was performed at a level I trauma centre. All patients were informed about the study and provided written informed consent.

All patients undergoing total elbow arthroplasty (TEA) were identified by electronically screening our database by the OPS codes 5-824.4 (implantation of a linked TEA) and 5-824.5 (implantation of an unlinked TEA) between August 2008 and May 2014. Based on patient records and x-rays the indication for implantation of the TEA was retrospectively reviewed. All patients, who received a TEA for an acute trauma with fracture of the distal humerus (primary TEA) or due to a failed reconstruction or non-operative treatment after a distal humerus fracture (secondary TEA), were included in this study. A minimum follow-up of 6 months was set as inclusion criterion. Exclusion criteria were previous injury at the fractured elbow, neuro-muscular disease, cortisone or other immune suppressive therapy and open fracture grade II or higher according to Tscherne and Ostern.The patient records were reviewed for demographic and perioperative data. If the initial treatment was not conducted in our department, radiographs and patient records were requested. The follow-up examination included the evaluation of the range of motion and stability of the elbow, actual pain and satisfaction of the patient. To objectify the functional result the Mayo Elbow Performance Score (MEPS) and Disabilities of the Arm, Shoulder and Hand Score (DASH) were determined. Additionally, complications and revision surgeries were recorded. Complications were split up into minor (nerve irritation or postoperative haematoma) and major complications, which required a revision of the prosthesis. Periprosthetic fractures due to renewed fall with an adequate trauma were not counted as complication.

Perioperative data, the functional result (range of motion, MEPS, DASH) and postoperative complications were described for each group. Subsequently, these results were statistically compared using the Mann-Whitney U test as a two-way analysis of variance for independent factors. A p-value ≤ 0.05 was considered statistically significant. The statistical analysis was performed using SPSS for MAC (IBM SPSS Statistics 22, Chicago, Illinois).

We hypothesised that clinical and functional results are better for primary TEA with less complications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Minimum age: 18 years Sex: All

Inclusion Criteria:

• Total elbow arthroplasty for an acute trauma with fracture due to an acute trauma

• Total elbow arthroplasty due to failed reconstruction after distal humerus fracture

• Total elbow arthroplasty after non-operatic treatment after distal humerus fracture

Exclusion Criteria:

• previous injury at the fractured elbow

• neuro-muscular disease

• cortisone or other immune suppressive therapy

• open fracture grade II or higher according to Tscherne and Ostern

Related Conditions & MeSH terms

• Elbow Arthropathy
• Elbow Fracture
• Fractures, Bone

Intervention

Procedure:
• Total elbow arthroplasty
Implantation of a total elbow arthroplasty after distal humerus fracture

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Diakoniekrankenhaus Friederikenstift

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	DASH score	Disabilities of the Arm, Shoulder and Hand: subjective score evaluation the function	minimum follow-up: 6 months
Primary	Range of motion	Measurement of the range of motion for extension/flexion	minimum follow-up: 6 months
Primary	Mayo Elbow Performance Score	Objective score evaluation the function of the elbow	minimum follow-up: 6 months
Secondary	Complication	appearance of a complication	minimum follow-up: 6 months