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| Name | Class |
|---|---|
| Central Finland Hospital District | OTHER |
| Satakunta Central Hospital | OTHER |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Other | Conservative treatment chosen by physician on-call for dorsally displaced radius fracture. |
|
| Arm 2 | Other | Conservative treatment chosen by physician on-call for dorsally displaced radius fracture. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flexion-ulnar cast | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Rated Wrist Evaluation (PRWE) measure is the primary outcome measure of wrist pain and disability in the study | The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists three subscales: Pain, Function and Cosmetics. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disability of the wrist measured with the Disability of the Arm, Shoulder and Hand (QuickDASH) questionnaire. | The QuickDASH is self-reported questionnaire and shortened version of DASH outcome measure to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb in 11 dimensions in 1-5 scale. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ville Mattila, MD, Professor | Tampere Univeristy Hospital | Study Director |
| Antti Launonen, MD, PhD | Tampere University Hospital | Principal Investigator |
| Teemu Hevonkorpi, MBBS | Tampere University Hospital | Study Chair |
| Lauri Raittio, MBBS | Tampere University Hospital | Study Chair |
| Toni Luokkala, MD | Central Finland Hospital District | Study Chair |
| Aleksi Reito, MD, PhD | Central Finland Hospital District | Study Chair |
| Juha Kukkonen, MD, PhD | Satakunta Central Hospital | Study Chair |
| Minna Laitinen, Adjacent prof | Tampere University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Finland Central Hospital | Jyväskylä | Finland | ||||
| Satakunta Central Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37023069 | Derived | 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. | |
| 32469881 |
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| ID | Term |
|---|---|
| D003100 | Colles' Fracture |
| D000092503 | Wrist Fractures |
| ID | Term |
|---|---|
| D000072039 | Fracture Dislocation |
| D004204 | Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000072700 | Conservative Treatment |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
|
| Functional cast | 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. |
|
|
| Quality of life measured with the 15-D. | The 15D is a validated, generic, self-administered instrument for assessing the health related quality of life among adults. It combines the advantages of a preference-based and single index measure on a 0-1 scale. | 2 years |
| Pain measured in Visual Analogue Scale (VAS). | The VAS is derived by health care professional question of pain in scale 0 to 10 in which 0 implies no pain and 10 the worst possible pain. | Baseline, 3 months, 1 year, 2 years |
| Range of motion (ROM) is measured with a goniometer | The ROM of the wrist is measured on both hands with a handheld goniometer in degrees. | 3 months |
| Grip strength is measured with a dynamometer | Grip strength is measured with a dynamometer in kg as the mean of three measurements. It will be numbered in percentage of the uninjured side. | 3 months |
| The pain catastrophizing scale (PCS) is measured with a self-administered questionnaire. | The PCS is designed to measure person's willingness to catastrophize the pain while they are experiencing it. In the questionnaire patients answer questions about how they feel and think when they are in pain and it can be taken while they are not experiencing pain. | 2 years |
| Pori |
| Finland |
| Tampere Univeristy Hospital | Tampere | Finland |
| Derived |
| 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. |
| 28923035 | Derived | 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. |
| D014947 |
| Wounds and Injuries |
| D011885 | Radius Fractures |
| D050723 | Fractures, Bone |
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |