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The aim of this study is to compare functional and radiological results in two groups of distal radius fractures treated with internal fixation with locking plate, and immobilized with antebrachial splint or compression bandage for 3 weeks.
The aim of the study is to compare functional and radiological results as well as to evaluate possible complications in distal radius fractures operated by open reduction and internal fixation with volar locking plate in two groups , one treated with immobilization using a forearm cast for 3 weeks and the other with immobilization using a compression bandage for 3 weeks, based on the hypothesis that compression bandage group could obtain better results in the short term, and none of the treatments is superior to the other after 3 or 6 months of evolution, as indicated by some reviewed studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Splint inmmobilization | Active Comparator | Distal radius fractures fixed with volar locking plate and immobilized with an antebrachial splint for 3 weeks |
|
| Bandage immovilization | Active Comparator | Distal radius fractures fixed with volar locking plate and immobilized with a compressive bandage for 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Splint inmmobilization | Device | After internal fixation with volar locking plate, groups of distal radius fractures are inmobilized with a plaster splint of París for 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain in Visual Analogue Scale. | Points from 1 to 10. Higher score: worse value. Lower score: better value. | 1 year |
| Function in Patient Rated Wrist Evaluation Scale. | Points from 1 to 100. Higher score: worse value. Lower score: better value. | 1 year |
| Range Of Motion in Flexion. | Grades from 0 to 70. Higher score: better value. Lower score: worse value. | 1 year |
| Range Of Motion in Flexion. | Grades from 0 to 80. Higher score: better value. Lower score: worse value. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Function in Disabilities of Arm, Shoulder and Hand Scale. | Points from 1 to 150. Higher score: worse value. Lower score: better value | 1 year |
| Function in Mayo Wrist Score Scale. | Points from 1 to 100. Higher score: worse value. Lower score: better value. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jose Ignacio Miró Jiménez, MD | Contact | +34 674501958 | ppnxmj89@gmail.com | |
| Alberto Izquierdo Fernández, Phd | Contact | +34 667789977 | alberto.izquierdo.fer@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Alberto Izquierdo Fernández, Phd | Hospital Reina Sofía ( Córdoba, Spain) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Reina Sofía | Recruiting | Córdoba | 14004 | Spain | ||
| Hospital Costa del Sol |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31579555 | Result | Delft EAKV, Gelder TGV, Vries R, Vermeulen J, Bloemers FW. Duration of Cast Immobilization in Distal Radial Fractures: A Systematic Review. J Wrist Surg. 2019 Oct;8(5):430-438. doi: 10.1055/s-0039-1683433. Epub 2019 Mar 18. | |
| 28428911 | Result | Quadlbauer S, Pezzei C, Jurkowitsch J, Kolmayr B, Keuchel T, Simon D, Hausner T, Leixnering M. Early Rehabilitation of Distal Radius Fractures Stabilized by Volar Locking Plate: A Prospective Randomized Pilot Study. J Wrist Surg. 2017 May;6(2):102-112. doi: 10.1055/s-0036-1587317. Epub 2016 Aug 5. |
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| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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2 parallel groups, each one receives one treatment
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Patient receive the correspondant treatment based on the order of an aleatory numbers table
| Bandage immovilization | Device | After internal fixation with volar locking plate, groups of distal radius fractures are inmobilized with compressive bandage for 3 weeks |
|
| 1 year |
| Range of motion in Supination. | Grades from 0 to 90. Higher score: better value. Lower score: worse value. | 1 year |
| Number of participants with posoperative complications. | Number of participants per group that suffer some complication or side effect during the follow-up period. Higher number of complications: worse value. | 1 year |
| Number of posoperative Fisiotherapy sessions performed. | Number of sessions per participant from 1 to 100. Higher score: worse value. Lower score: better value. | 1 year |
| Time of fracture union in radiographs. | Number of Weeks from 1 to 12. Higher score: worse value. Lower score: better value. | 12 weeks |
| Number of Instability distal radius fracture Criteria per participant. | Number of criteria from 1 to 6. Higher score: worse value. Lower score: better value. | 1 year |
| Grades of Dorsal Displacement in fracture. | Grades from -10 to 30 grades. Higher score: worse value. Lower score: better value. | 6 weeks |
| Range of motion in Pronation. | Grades from 0 to 90. Higher score: better value. Lower score: worse value. | 1 year |
| Range of motion in Radial Deviation | Grades from 0 to 15. Higher score: better value. Lower score: worse value. | 1 year |
| Range of motion in Ulnar deviation. | Grades from 0 to 30. Higher score: better value. Lower score: worse value. | 1 year |
| Number of shortening millimeters in fracture. | Number of millimeters from 0-10. Higher score: worse value. Lower score: better value. | 6 weeks |
| Number of ulnar variance millimeters in fracture. | Number of millimeters from -2 to +4. Higher score: worse value. Lower score: better value. | 6 weeks |
| Number of step-off millimeters in fracture. | Number of millimeters from 0 to 4 mm. Higher score: worse value. Lower score: better value. | 6 weeks |
| Recruiting |
| Málaga |
| 29603 |
| Spain |
|
| 35186419 | Result | Toemen A, Collocott S, Heiss-Dunlop W. Short Term Outcomes Following Open Reduction Internal Fixation Surgery for a Distal Radius Fracture: 2 Week Versus 4 Week Immobilization. A Retrospective Analysis. Geriatr Orthop Surg Rehabil. 2021 Mar 25;12:21514593211004528. doi: 10.1177/21514593211004528. eCollection 2021. |
| 25748659 | Result | Klein SM, Prantl L, Koller M, Vykoukal J, Dolderer JH, Graf S, Nerlich M, Loibl M, Geis S. Evidence based postoperative treatment of distal radius fractures following internal locking plate fixation. Acta Chir Orthop Traumatol Cech. 2015;82(1):33-40. |
| 21508285 | Result | Lichtman DM, Bindra RR, Boyer MI, Putnam MD, Ring D, Slutsky DJ, Taras JS, Watters WC 3rd, Goldberg MJ, Keith M, Turkelson CM, Wies JL, Haralson RH 3rd, Boyer KM, Hitchcock K, Raymond L; American Academy of Orthopaedic Surgeons. American Academy of Orthopaedic Surgeons clinical practice guideline on: the treatment of distal radius fractures. J Bone Joint Surg Am. 2011 Apr 20;93(8):775-8. doi: 10.2106/JBJS.938ebo. No abstract available. |
| 24508093 | Result | Valdes K, Naughton N, Michlovitz S. Therapist supervised clinic-based therapy versus instruction in a home program following distal radius fracture: a systematic review. J Hand Ther. 2014 Jul-Sep;27(3):165-73; quiz 174. doi: 10.1016/j.jht.2013.12.010. Epub 2014 Jan 3. |
| 23770202 | Result | Driessens S, Diserens-Chew T, Burton C, Lassig E, Hartley C, McPhail S. A retrospective cohort investigation of active range of motion within one week of open reduction and internal fixation of distal radius fractures. J Hand Ther. 2013 Jul-Sep;26(3):225-30; quiz 231. doi: 10.1016/j.jht.2013.05.002. Epub 2013 Jun 14. |
| 25157038 | Result | Koval K, Haidukewych GJ, Service B, Zirgibel BJ. Controversies in the management of distal radius fractures. J Am Acad Orthop Surg. 2014 Sep;22(9):566-75. doi: 10.5435/JAAOS-22-09-566. |
| 18519324 | Result | Lozano-Calderon SA, Souer S, Mudgal C, Jupiter JB, Ring D. Wrist mobilization following volar plate fixation of fractures of the distal part of the radius. J Bone Joint Surg Am. 2008 Jun;90(6):1297-304. doi: 10.2106/JBJS.G.01368. |
| 29256945 | Result | Meinberg EG, Agel J, Roberts CS, Karam MD, Kellam JF. Fracture and Dislocation Classification Compendium-2018. J Orthop Trauma. 2018 Jan;32 Suppl 1:S1-S170. doi: 10.1097/BOT.0000000000001063. No abstract available. |