Results of the Anser Clavicle Pin for treatment of Midshaft Clavicle Fractures

Results of the Anser Clavicle Pin for treatment of Midshaft Clavicle Fractures - Results of the Anser Clavicle Pin

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52512

Enrollment

100

Registered

2020-10-22

Start date

2021-06-04

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

clavicle fracture collarbone break

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

16 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Displaced midshaft clavicle fracture Type 2B or 2C according to the Robinson Classification • Age >= 18 years, • Surgery

Exclusion criteria

Exclusion criteria: • All patients deemed not fit for surgery by the anesthesiologist • All patients with nonunion or previous malunion • Patients

Design outcomes

Primary

Measure	Time frame
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 months and 1 year postoperative visits.	—

Measure

Time frame

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 months and 1 year 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, return to work, health related quality of life and cosmetic satisfaction. Closed reduction is defined as advancing the Anser Clavicle Pin 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 patient satisfaction result after 6 weeks, 3 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, return to work, health related quality of life and cosmetic satisfaction. Closed reduction is defined as advancing the Anser Clavicle Pin 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 patient satisfaction result after 6 weeks, 3 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)