The Impact of Clavicular Length Restoration in the Treatment of Non-unions of Clavicular Midshaft and Lateral Fractures

Completed

• Conditions: Clavicular Length
• Interventions: Other: Follow- up (FU) assessment

• Registration Number: NCT03816436
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

Evaluating the impact of plate treatment and cortical bone grafting of clavicular midshaft and lateral non- unions on restoration of clavicular length and bony healing and its association with functional outcome.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-17
• Primary Completion: 2018-09-25
• Study Completion: 2018-09-25
• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-01-22
• Study First Posted: 2019-01-25
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-23
• Last Update Posted: 2019-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• clavicular midshaft and lateral non- union treated by plate and iliac crest bone grafting
• minimal follow- up of two years after surgery
• written informed consent

Exclusion Criteria

• legal incompetence
• non- union of pathologic fractures
• current pregnancy
• German language barrier to complete questionnaires

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Follow- up (FU) assessment on clavicular non- union	Follow- up (FU) assessment	clavicular midshaft and lateral non- union treated by plate and iliac crest bone grafting

Primary Outcome Measures

Name	Time	Method
Clavicula shortening (cm)	one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting	Clavicula shortening (cm) based on Imaging assessment (x-ray, ultrasound), dichotomous outcome with shortening less or equal 2 cm (yes/no).

Secondary Outcome Measures

Name	Time	Method
Constant Murley score (CS)	one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting	tool for assessment of shoulder function: Range of Motion (ROM) of shoulder (degree), abduction strength (kg), Quality of Life (QoL) questionnaire. The different scales are summed and normalized to 0=worst to 100=best.
Subjective shoulder pain (NRS)	one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting	Patient rates pain at rest and at motion of the treated shoulder on numeric scale ranging from 0 (no pain) to 10 (maximum possible pain)
Simple shoulder test (SST)	one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting	12 items questionnaire to assess restrictions in activities of daily living (ADL) related to impaired shoulder function; response in dichotomous manner (yes/no)
Quality of Life (QoL)	one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting	assessed by Quality of Life EuroQoL 5D-5L Instrument (EQ-5D-5L); the descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Subjective shoulder value (SSV)	one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting	based on a single question answered subjectively by Patient: "What is the overall percent value of your shoulder if a completely normal shoulder represents 100%?"

Trial Locations

Locations (2)

Schulthess Klinik Zürich; 🇨🇭 Zürich, Switzerland

Department of Orthopaedics; 🇨🇭 Basel, Switzerland