Operative vs. Conservative Treatment of Distal Radius Fractures

NCT03716661 | Completed

• 1 other identifier: 1-10-72-420-17
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Radius Distal Fracture; Distal Radius Fracture; Radius Fracture Distal

Outcome Measures

Primary Outcomes (13)

• Number of participants with treatment-related complications at baseline

  Baseline

• Change in number of participants with treatment-related complications from baseline at week 2

  Week 2

• Change in number of participants with treatment-related complications from baseline at week 5

  Week 5

• Change in number of participants with treatment-related complications from baseline at month 6

  Month 6

• Change in number of participants with treatment-related complications from baseline at 1 year

  1 Year

• Range of motion of the wrist at week 5

  a. Flexion (0-90 degrees) b. Extension (0-75 degrees) c. Pronation (0-90 degrees) d. Supination (0-90 degrees) e. Radial flexion (0-25 degrees) f. Ulnar flexion (0-50 degrees)

  Week 5

• Change in range of motion of the wrist from week 5 at month 6

  a. Flexion (0-90 degrees) b. Extension (0-75 degrees) c. Pronation (0-90 degrees) d. Supination (0-90 degrees) e. Radial flexion (0-25 degrees) f. Ulnar flexion (0-50 degrees)

  Month 6

• Change in range of motion of the wrist from month 6 at 1 year

  a. Flexion (0-90 degrees) b. Extension (0-75 degrees) c. Pronation (0-90 degrees) d. Supination (0-90 degrees) e. Radial flexion (0-25 degrees) f. Ulnar flexion (0-50 degrees)

  1 Year

• Level of functioning at baseline

  Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)

  Baseline

• Change in level of functioning from baseline at week 2

  Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)

  Week 2

• Change in level of functioning from baseline at week 5

  Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)

  Week 5

• Change in level of functioning from baseline at month 6

  Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)

  Month 6

• Change in level of functioning from baseline at 1 year

  Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)

  1 Year

Study Arms (3)

Control

NO INTERVENTION

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

Conservative

NO INTERVENTION

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

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)

Procedure: ORIF

Interventions

ORIF PROCEDURE

Open Reduction Internal Fixation

Operative

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Danish National Guidelines for operative treatment of distal radius fractures

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Regionshospitalet Randers

Randers, 8930, Denmark

Location

Related Publications (3)

• Thorninger R, Waever D, Tjornild M, Lind M, Rolfing JD. Prospective Evaluation of Two Cohorts of Non-Operatively Treated Patients with Displaced vs. Minimally and Non-Displaced Distal Radius Fractures. J Clin Med. 2023 Mar 6;12(5):2076. doi: 10.3390/jcm12052076.

  PMID: 36902861 DERIVED

• Thorninger R, Waever D, Tjornild M, Lind M, Rolfing JD. VOLCON: a randomized controlled trial investigating complications and functional outcome of volar plating vs casting of unstable distal radius fractures in patients older than 65 years. J Orthop Traumatol. 2022 Nov 28;23(1):54. doi: 10.1186/s10195-022-00673-4.

  PMID: 36443579 DERIVED

• Pedersen J, Mortensen SO, Rolfing JD, Thorninger R. A protocol for a single-center, single-blinded randomized-controlled trial investigating volar plating versus conservative treatment of unstable distal radius fractures in patients older than 65 years. BMC Musculoskelet Disord. 2019 Jun 29;20(1):309. doi: 10.1186/s12891-019-2677-y.

  PMID: 31253145 DERIVED

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: October 23, 2018
• Study Start: November 1, 2018
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-05

Locations

DK (1)