Operative vs. Conservative Treatment of Distal Radius Fractures

University of Aarhus

Status: Completed

Conditions: Radius Distal Fracture; Distal Radius Fracture; Radius Fracture Distal

Treatments: Procedure: ORIF

Study type: Interventional

Funder types: Other

Identifiers

NCT03716661

1-10-72-420-17

Details and patient eligibility

About

Even though broken wrists are of frequent occurrence, the investigators see a lack of extensive and well executed international studies to clarify which is the best treatment for elderly participants at 65+ years. The Danish Health and Medicines Authority recommend that broken wrists are treated with surgery by using plates and screws when certain radiological criteria are met. Recent studies show that, apparently, there are no advantages by operating rather than treating with plaster when comparing the functional results after one year. However, there is a 30 % risk of serious complications occurring after surgery. This study will examine the pros and cons that participants at 65+ years with broken wrists experience after, by lot, having been treated with either surgery (using plates and screws) or without surgery (using plaster for 5 weeks). The purpose of this study is to compare the complications and level of functioning between participants treated with surgery and without surgery.

Enrollment: 150 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Danish National Guidelines for operative treatment of distal radius fractures

Exclusion criteria

• Patients treated with plaster in Arm1/control group who unexpectedly requires surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

150 participants in 3 patient groups

Control

No Intervention group

Description:

Arm 1/control group: Participants who are treated with conservative plaster following National Clinical Guidelines.

Conservative

No Intervention group

Description:

Arm 2 and 3 consist of participants fulfilling the criteria for operative treatment following National Clinical Guidelines. Arm 2: Patients randomized to conservative plaster treatment

Operative

Other group

Description:

Arm 2 and 3 consist of participants fulfilling the criteria for operative treatment following National Clinical Guidelines. Arm 3: Patients randomized to operative treatment (ORIF)

Treatment:

Procedure: ORIF