## Protocol Section
### Identification Module
**NCT ID:** NCT00609479

**Brief Title:** Comparison of Two Methods for Treatment of Colles´s Fracture

**Official Title:** Comparison of External and Internal Fixationmethods for Distal Radius Fracture - a Randomized Study.

#### Organization Study ID Info
**ID:** JOS-1
#### Organization
**Class:** OTHER
**Full Name:** University of Aarhus
#### Secondary ID Infos
**ID:** JOS-1
### Status Module
#### Completion Date
**Date:** 2010-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2010-04-12

**Type:** ESTIMATED

**Last Update Submit Date:** 2010-04-09

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2010-02

**Type:** ACTUAL

#### Start Date
**Date:** 2008-01

**Status Verified Date:** 2010-04

#### Study First Post Date
**Date:** 2008-02-07
**Type:** ESTIMATED
**Study First Submit Date:** 2008-01-24
**Study First Submit QC Date:** 2008-02-06
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Aarhus

#### Responsible Party

**Old Name Title:** MD/PhD-stud. Jesper Ougaard Schønnemann

**Old Organization:** Orthopedic Research Unit, Regionhospital Holstebro

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to compare two different fixationmethods for fractures of the wrist(distal radius fractures). We are comparing an external fixation (Hoffmann-II-non-bridging) vs. an internal fixation(Micronail). Primary endpoint is patient satisfaction as scored by the DASH-questionnaire.Secondary followup is X-rays, strength, PRWE-questionnaire.

### Conditions Module

**Conditions:**

- Distal Radius Fracture

- Colle´s Fracture

**Keywords:**

- Distal radius fracture

- Colle´s fracture

- Internal fixation

- External fixation

- DASH

- PRWE

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Internal fixation with Micronail. 41 patients.

**Intervention Names:**

- Procedure: Osteosynthesis

**Label:** 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** External fixation with Hoffmann-II-non-bridging. 41 patients.

**Intervention Names:**

- Procedure: Osteosynthesis

**Label:** 2

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

- 2

**Description:** 1. Micronail osteosynthesis. A cast for the first 14 days, thereafter starting physiotherapy. Control at weeks 1,2,5,12.
2. Hoffmann-II-non-bridging osteosynthesis. Removal of device after 5 weeks. physiotherapy starts at 14 days. Control at weeks 1,2,5,12.

**Name:** Osteosynthesis

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Measure:** DASH-questionnaire

**Time Frame:** 3 months

#### Secondary Outcomes

**Measure:** PRWE-questionnaire

**Time Frame:** 3 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Fracture Older type 2.
* Fracture Older type 3.

Exclusion Criteria:

* Fractures older than 3 weeks.
* Pregnancy.
* Seq. after previous fracture.
* Distal fragments volar cortex \< 10 mm.
* Open fracture larger than Gustillo 1.
* Disability due to other illness.
* Congenital abnormity or injury/disease in the affected extremity.
* Not capable of mentally/physically to cooperate.
* Not able to go to followup on the operating hospital.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Herning

**Country:** Denmark

**Facility:** Regionhospital Herning

**Zip:** 7400

**Location 2:**

**City:** Holstebro

**Country:** Denmark

**Facility:** Regionhospital Holstebro

**Zip:** 7500

**Location 3:**

**City:** Viborg

**Country:** Denmark

**Facility:** Regionhospital Viborg

**Zip:** 8800

#### Overall Officials

**Official 1:**

**Affiliation:** Department of Orthopedics, University of Aarhus, Denmark

**Name:** Kjeld Søballe, MD; PhD; Prof.

**Role:** STUDY_CHAIR

### References Module

#### See Also Links

**Label:** Related Info

**URL:** http://www.orthoresearch.dk

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000005543

- Term: Forearm Injuries

- ID: D000001134

- Term: Arm Injuries

- ID: D000014954

- Term: Wrist Injuries

- ID: D000072039

- Term: Fracture Dislocation

- ID: D000004204

- Term: Joint Dislocations

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

### Condition Browse Module - Browse Leaves

- ID: M26370

- Name: Fractures, Bone

- Relevance: HIGH

- As Found: Fracture

- ID: M14731

- Name: Radius Fractures

- Relevance: HIGH

- As Found: Radius Fracture

- ID: M6328

- Name: Colles' Fracture

- Relevance: HIGH

- As Found: Colles' Fracture

- ID: M2933

- Name: Wrist Fractures

- Relevance: HIGH

- As Found: Distal Radius Fracture

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M8667

- Name: Forearm Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M4444

- Name: Arm Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M17692

- Name: Wrist Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M909

- Name: Fracture Dislocation

- Relevance: LOW

- As Found: Unknown

- ID: M7385

- Name: Joint Dislocations

- Relevance: LOW

- As Found: Unknown

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003100

- Term: Colles' Fracture

- ID: D000050723

- Term: Fractures, Bone

- ID: D000011885

- Term: Radius Fractures

- ID: D000092503

- Term: Wrist Fractures

### Misc Info Module

- Version Holder: 2024-05-24
