Initial results of the Anser: A novel intramedullary device for fixation of midshaft clavicle fractures. An explorative case series

Initial results of the Anser: A novel intramedullary device for fixation of midshaft clavicle fractures. An explorative case series - Results of the Anser Novel Device

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43088

Enrollment

Registered

2016-09-26

Start date

2017-05-19

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clavicle Fracture Collarbone Fracture

Interventions

The surgical technique for the Anser will be as described in the implant brochure. Patients are administered prophylactic antibiotics. With a general anesthetic, the patient is placed in a beach-cha

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Displaced midshaft clavicle fracture Type 2A1 or 2B1 according to the Robinson Classification • Age > 18 years,

Exclusion criteria

Exclusion criteria: • All patients deemed not fit for surgery by the anesthesiologist • All patients with nonunion or previous malunion • Patients 65 years • Possible noncompliant patients (eg, alcohol and drug addiction, dementia) • Additional neurovascular injury • Pathologic fractures

Design outcomes

Primary

Measure	Time frame
Pre-operatively base-line characteristics of the participating patients will be noted. These base-line characteristics are: • Age • Gender • BMI • Dominant arm • Occupation • Trauma mechanism • Medical history • Medication • Smoking • SF-36 Questionnaire • Sports (if yes; at what level? Recreational or professional) • Robinson Classification The primary outcome measures will be union rate, complication rate and functional outcome scores. Union is defined as a 2/3rd circumferential cortical bridging between medial and lateral fragments on both radiographs as determined by the treating surgeon and an independent radiologist. Complication is defined as any general or implant-related adverse effect intra- and postoperatively. Functional Outcome scores will be measured with using the Constant score and DASH score at the 6 weeks, 3, 6 and 12 months postoperative visits.	—

Measure

Time frame

Pre-operatively base-line characteristics of the participating patients will be noted. These base-line characteristics are: • Age • Gender • BMI • Dominant arm • Occupation • Trauma mechanism • Medical history • Medication • Smoking • SF-36 Questionnaire • Sports (if yes; at what level? Recreational or professional) • Robinson Classification The primary outcome measures will be union rate, complication rate and functional outcome scores. Union is defined as a 2/3rd circumferential cortical bridging between medial and lateral fragments on both radiographs as determined by the treating surgeon and an independent radiologist. Complication is defined as any general or implant-related adverse effect intra- and postoperatively. Functional Outcome scores will be measured with using the Constant score and DASH score at the 6 weeks, 3, 6 and 12 months postoperative visits.

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Secondary

Measure	Time frame
Secondary outcomes will be closed reduction rate, operative time, image-intensifier time, hospital stay, incision length, time to radiological union, pain, re-operation, health related quality of life and cosmetic satisfaction. Closed reduction is defined as advancing the Anser through both lateral and medial fragments without opening the skin over the fracture site. Operative time and image-intensifier time will be measured in minutes. Hospital stay will be measured in days. Incision length will be measured using a tape measure at the 6 week outpatient clinic visit by an independent reviewer. Time to radiological union will be measured in weeks. Pain is assessed with a VAS pain 10-point scale (0 = no pain and 10 = extremely painful). Also participating patients are asked to note the type and amount of analgesics used. Re-operation is defined as any additional surgery after implantation of the Anser for any reason. Health related quality of life is assessed using the SF 36. The SF 36 is a validated questionnaire designed to measure health related quality of life. The cosmetic result after 6 weeks, 3 and 6 months, and 1 year is assessed using the VAS patient satisfaction score on a 0 (= very unsatisfactory) to 10 (= very satisfactory) scale.	—

Measure

Time frame

Secondary outcomes will be closed reduction rate, operative time, image-intensifier time, hospital stay, incision length, time to radiological union, pain, re-operation, health related quality of life and cosmetic satisfaction. Closed reduction is defined as advancing the Anser through both lateral and medial fragments without opening the skin over the fracture site. Operative time and image-intensifier time will be measured in minutes. Hospital stay will be measured in days. Incision length will be measured using a tape measure at the 6 week outpatient clinic visit by an independent reviewer. Time to radiological union will be measured in weeks. Pain is assessed with a VAS pain 10-point scale (0 = no pain and 10 = extremely painful). Also participating patients are asked to note the type and amount of analgesics used. Re-operation is defined as any additional surgery after implantation of the Anser for any reason. Health related quality of life is assessed using the SF 36. The SF 36 is a validated questionnaire designed to measure health related quality of life. The cosmetic result after 6 weeks, 3 and 6 months, and 1 year is assessed using the VAS patient satisfaction score on a 0 (= very unsatisfactory) to 10 (= very satisfactory) scale.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)