Double Plating Versus Single Plating Techniques in Midshaft Clavicle Fractures
- Conditions
- Clavicle Fracture
- Interventions
- Procedure: Clavicle plating
- Registration Number
- NCT05579873
- Lead Sponsor
- Luzerner Kantonsspital
- Brief Summary
The goal of this mutlicenter quasi-randomized observational cohort study is to compare single vs double plating in patients with a midshaft clavicle fracture. The main question it aims to answer is:
1. Does low profile double plating of midshaft clavicle fractures with one 2.0mm plate and a second 2.4 or 2.7 mm plate lead to a lower rate of re-intervention when compared to either single superior or single anterior plating?
- Detailed Description
Clavicle fractures account for 2% to 5% of all fractures in adults, with a majority of patients being young and active. A gold standard for the treatment of clavicle fractures has yet to be established, but single plated surgical intervention is most widely used. In recent years a smaller double plating technique has been described as a possible solution to the high removal rates associated with single plating. In (orthopaedic) surgery however, randomized controlled trials (RCTs) are recognized for their limitations. Although RCTs are considered the gold standard for testing the efficacy of new interventions, randomisation and blinding can be challenging. Simultaneously, there is an inclination for the usage of RCTs in clinical protocols, frequently based on the credo that it is the only valid method of comparing treatments. A natural experiment (NE), or quasi-experiments, in which groups are compared by nature of factors outside the control of the investigator (i.e. different surgical techniques between centres), offers a possible solution for methodological quality control. This study aims to increase the knowledge on surgical outcomes for single vs double plating in midshaft clavicle fractures following a natural experiment design.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 336
- 18 years and older
- Primary mid-shaft clavicula fracture defined as the middle third of the clavicle (Robinson Type II or AO 15.2)
- Patients that are eligible for operative treatment of clavicle fractures.
Generally accepted indications include:
- Displacement of one or more shaft width
- Shortening of more than 1cm in length
- High demand patients (physical activity)
- Delayed presentation (> 14 days)
- Initial operative treatment at non-participating hospitals
- Open fractures
- Pathological fractures
- Re-fractures of clavicle
- Concomitant ipsilateral injury of upper extremity (including but not limited to shoulder, scapula, and ribs)
- Cognitive impairment or language barrier precluding answering questionnaires
- Unable to complete follow-up (e.g. different residential area/tourists)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Single plating technique Clavicle plating Choice of implant used for single plating left at descretion of treating surgeon. Double plating technique Clavicle plating Double plating consist of one VariAx 2.0mm plate positioned on the superior aspect of the clavicula and a second VariAx 2.4mm or 2.7 mm on the anterior side. Use of this implant will be according to the device's cleared indications of use.
- Primary Outcome Measures
Name Time Method Number of surgical re-interventions 2 years follow-up Any type of re-intervention (i.e. plate removal, screw adjustment etc.)
- Secondary Outcome Measures
Name Time Method Number of surgical re-interventions 1 year follow-up (including implant removal)
Fracture realted infections 2 years follow-up According to metsemakers et al, 2018 (Metsemakers WJ, Morgenstern M, McNally et al., MHJ. Fracture-related infection: A consensus on definition from an international expert group. Injury. 2018 Mar;49(3):505-510. doi: 10.1016/j.injury.2017.08.040. Epub 2017 Aug 24. PMID: 28867644)
Symptomatic non union 1 year follow-up defined as absence of radiological signs of healing (callus formation or fading of fracture lines) combined with pain at the fracture site at 12 months.
Asymptomatic non-union 1 year follow-up defined as absence of radiological signs of healing (callus formation or fading of fracture lines) without any clinical symptoms.
Numbness below scar line 1 year follow-up Tested postoperatively and at 12 months follow-up
Self-reported implant irritation/implant prominence 1 year follow-up According to Hulsman et al, 2018 (17. Hulsmans M, van Heijl M, Houwert R, et al., Intramedullary nailing of displaced midshaft clavicle fractures using a TEN with end cap: issues encountered. Acta Orthop Belg. 2018 Dec;84(4):479-484. PMID: 30879453.)
Operative time Baseline Length of surgical incision basline Length of surgical incision in cm
DASH score baseline, 3- and 12-monts follow-up The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.
EQ-5D baseline (pre-injury), 3- and 12-months follow-up to monitor changes in self-reported health status through time in a given patient group
VAS pain score 3- and 12-months follow-up Self-reported pain on a scale of 0 to 10.
VAS for patient satisfaction 3- and 12-months follow-up Self-reported satisfaction on a scale of 0 to 10