Conservative Treatment of Distal Radius Fracture in Elderly in Randomized Controlled Trial

NCT ID: NCT02894983

Last Updated: 2018-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-05-31

Brief Summary

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There is no consensus about the best conservative treatment for patients with dorsally displaced distal radius fractures. The previous studies that have examined the most valid method for cast immobilization have lacked uniform and patient-rated outcome measures, proper randomization and sufficient study population. The aim of this study is to compare functional position cast to flexion-ulnar -deviation with dorsally displaced distal radius fractures in patients aged 65 years or older. The conservative treatment is performed in clinical practice by various health care professionals with different techniques of reduction which are not limited to any specific technique in this pragmatic, randomized controlled trial.

Detailed Description

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Conditions

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Colles' Fracture Distal Radius Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Conservative treatment chosen by physician on-call for dorsally displaced radius fracture.

Group Type OTHER

Flexion-ulnar cast

Intervention Type OTHER

The group will be treated with closed reduction and flexion-ulnar deviation position cast. This will take place under local anaesthesia by means of local infiltration commonly used in Finland. There is no preferable method for performing the reduction. Additional radiographs will be taken to verify the success of the reduction one week after the reduction and after two and five weeks of casting if treating health care professional it requires. The cast will be disposed after 5 weeks.

Arm 2

Conservative treatment chosen by physician on-call for dorsally displaced radius fracture.

Group Type OTHER

Functional cast

Intervention Type OTHER

The group will be treated with closed reduction and functional position cast. This will take place under local anaesthesia by means of local infiltration commonly used in Finland. There is no preferable method for performing the reduction. Additional radiographs will be taken to verify the success of the reduction one week after the reduction and after two and five weeks of casting if treating health care professional it requires. The cast will be disposed after 5 weeks.

Interventions

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Flexion-ulnar cast

The group will be treated with closed reduction and flexion-ulnar deviation position cast. This will take place under local anaesthesia by means of local infiltration commonly used in Finland. There is no preferable method for performing the reduction. Additional radiographs will be taken to verify the success of the reduction one week after the reduction and after two and five weeks of casting if treating health care professional it requires. The cast will be disposed after 5 weeks.

Intervention Type OTHER

Functional cast

The group will be treated with closed reduction and functional position cast. This will take place under local anaesthesia by means of local infiltration commonly used in Finland. There is no preferable method for performing the reduction. Additional radiographs will be taken to verify the success of the reduction one week after the reduction and after two and five weeks of casting if treating health care professional it requires. The cast will be disposed after 5 weeks.

Intervention Type OTHER

Other Intervention Names

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Conservative treatment Conservative treatment

Eligibility Criteria

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Inclusion Criteria

* Low energy intra- or extra-articular dorsal primarily stable, reducible DRF within 3 cm of the radiocarpal joint diagnosed with lateral and posterior-anterior radiographs in ER
* Physician on-call (general practitioner, acute physician, orthopedic resident, orthopedic consult) thinks patient could be appropriate for non-operative treatment

Exclusion Criteria

* Operative treatment
* Refuse to participate the study
* Open fracture more than Gustilo 1 gradus
* Age under 65 years
* Chauffeure's or Barton´s fracture
* Smith´s fracture (volar angulation of the fracture)
* Does not understand written and spoken guidance in local languages
* Pathological fracture or previous fracture in the same wrist, forearm or elbow
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Finland Hospital District

OTHER

Sponsor Role collaborator

Satakunta Central Hospital

OTHER

Sponsor Role collaborator

Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Teemu Hevonkorpi

MBBS

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ville Mattila, MD, Professor

Role: STUDY_DIRECTOR

Tampere Univeristy Hospital

Antti Launonen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Teemu Hevonkorpi, MBBS

Role: STUDY_CHAIR

Tampere University Hospital

Lauri Raittio, MBBS

Role: STUDY_CHAIR

Tampere University Hospital

Toni Luokkala, MD

Role: STUDY_CHAIR

Central Finland Central Hospital

Aleksi Reito, MD, PhD

Role: STUDY_CHAIR

Central Finland Central Hospital

Juha Kukkonen, MD, PhD

Role: STUDY_CHAIR

Satakunta Central Hospital

Minna Laitinen, Adjacent prof

Role: STUDY_CHAIR

Tampere University Hospital

Locations

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Central Finland Central Hospital

Jyväskylä, , Finland

Site Status

Satakunta Central Hospital

Pori, , Finland

Site Status

Tampere Univeristy Hospital

Tampere, , Finland

Site Status

Countries

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Finland

References

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Ax M, Reito A, Hevonkorpi TP, Palola V, Kukkonen J, Luokkala T, Laitinen MK, Launonen AP, Mattila VM. A comparison of the functional results and costs of functional cast and volar-flexion ulnar deviation cast at 2-year follow-up in 105 patients aged 65 and older with dorsally displaced distal radius fracture: A randomized controlled trial. PLoS One. 2023 Apr 6;18(4):e0283946. doi: 10.1371/journal.pone.0283946. eCollection 2023.

Reference Type DERIVED
PMID: 37023069 (View on PubMed)

Raittio L, Launonen AP, Hevonkorpi T, Luokkala T, Kukkonen J, Reito A, Laitinen MK, Mattila VM. Two casting methods compared in patients with Colles' fracture: A pragmatic, randomized controlled trial. PLoS One. 2020 May 29;15(5):e0232153. doi: 10.1371/journal.pone.0232153. eCollection 2020.

Reference Type DERIVED
PMID: 32469881 (View on PubMed)

Raittio L, Launonen A, Hevonkorpi T, Luokkala T, Kukkonen J, Reito A, Sumrein B, Laitinen M, Mattila VM. Comparison of volar-flexion, ulnar-deviation and functional position cast immobilization in the non-operative treatment of distal radius fracture in elderly patients: a pragmatic randomized controlled trial study protocol. BMC Musculoskelet Disord. 2017 Sep 18;18(1):401. doi: 10.1186/s12891-017-1759-y.

Reference Type DERIVED
PMID: 28923035 (View on PubMed)

Other Identifiers

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R16035

Identifier Type: -

Identifier Source: org_study_id

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