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

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.

Study Overview

• Status: Completed
• Conditions: Clavicular Length
• Intervention / Treatment: Other: Follow- up (FU) assessment

• Study Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Department of Orthopaedics
  • Zürich, Switzerland, 8008
    • Schulthess Klinik Zürich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients surgically treated at the Schulthess Clinic (KWS) and at the University Hospital Basel (USB) for internal fixation with a plate and using iliac bone graft of clavicular non- unions.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Follow- up (FU) assessment on clavicular non- union; clavicular midshaft and lateral non- union treated by plate and iliac crest bone grafting	Other: Follow- up (FU) assessment; Follow- up (FU) assessment (clinical examination and patient questionnaires) at least 24 months after surgery (clavicular midshaft and lateral non- union treated by plate and iliac crest bone grafting)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constant Murley score (CS)	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.	one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting
Subjective shoulder pain (NRS)	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)	one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting
Subjective shoulder value (SSV)	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%?"	one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting
Simple shoulder test (SST)	12 items questionnaire to assess restrictions in activities of daily living (ADL) related to impaired shoulder function; response in dichotomous manner (yes/no)	one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting
Quality of Life (QoL)	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.	one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Andreas Mueller, PD Dr. med, Orthopädische Universitätsklinik Basel

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2018
• Primary Completion (Actual): September 25, 2018
• Study Completion (Actual): September 25, 2018

Study Registration Dates

• First Submitted: January 22, 2019
• First Submitted That Met QC Criteria: January 22, 2019
• First Posted (Actual): January 25, 2019

Study Record Updates

• Last Update Posted (Actual): April 24, 2019
• Last Update Submitted That Met QC Criteria: April 23, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: clavicle non-unions; plate treatment of clavicular fractures; cortical bone grafting of clavicular fractures; clavicular midshaft non- union; clavicular lateral non- union; clavicular shortening
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 2018-00120; ch19Mueller

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No