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Due to poor patient accrual
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Rationale:
Many different closed techniques are used to reduce a dorsally dislocated distal radius fracture (Colles' fracture). One trial to compare two main techniques (finger-trap traction and manual manipulation) did not find significant difference in radiological and clinical outcome (Earnshaw 2002). This trial aims to investigate patient and medical satisfaction between both techniques
Objective:
To demonstrate patient satisfaction (pain, duration, general) and medical satisfaction (difficulty of reposition). It is suggested that finger-trap traction causes less pain for patients and is more easy than manual manipulation but have the same radiological and clinical outcome.
Study design:
Randomised controlled intervention study
Study population:
300 Patients with newly diagnosed closed distal radius fractures with dorsal angulation (Colles' fracture) older than 16years coming to the Emergency Medical Department.
Intervention:
One group is put in finger-trap traction (digitus 1-3) for 10minutes with 4-5kg of ballast on their upper arm followed by reduction by dorsal pressure. The other group is manually reduced according to Charnley with traction and "hooking over" of the fracture elements.
Main study parameters/endpoints:
Visual analogue scale of patient and medical satisfaction, percentage of successful primary reductions. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Apart for the regular follow-up of patients with distal radius fractures,one extra out-patient visit is necessary to assess functional outcome after three months.Finger-trap traction has a (theoretical) risk of causing traumatic damage to ligaments of the fingers, but this risk is in our opinion not higher than in the manual manipulation. It is expected that the finger-trap traction group is more satisfied because this technique seems less traumatic than but as successful as the manual manipulation group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Manual Manipulation |
|
| 2 | Active Comparator | Finger Trap Traction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual Manipulation | Procedure | The currently used method for reduction: using manual traction to reduce the distal radial fragment by hyperextension followed by hyperflection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the difference in satisfaction of both patient and treating doctor between two well-known techniques of fracture reposition provided that both techniques show equal results in clinical and radiological outcome. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| To describe the functional outcome after three months, complication rate and osteoporosis rate in an urban community of a level-2 trauma-centre. | 3 months |
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Inclusion Criteria:
Patients of 16 years and older visiting our EMD with newly diagnosed closed distal radius fractures:
within 2cm of the radiocarpal joint
with dorsoradial dislocation (Colles' fractures),
AO-type 23.A2 and 23.A3 (extra-articular) and 23-C1 and 23-C2 (intra-articular)
which are in need for reduction. I.e. Colles' fractures:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karel Kolkman, MD, surgeon | Rijnstate Hospital Arnhem | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alysis Rijnstate Hospital | Arnhem | Gelderland | 6815AD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11886903 | Background | Earnshaw SA, Aladin A, Surendran S, Moran CG. Closed reduction of colles fractures: comparison of manual manipulation and finger-trap traction: a prospective, randomized study. J Bone Joint Surg Am. 2002 Mar;84(3):354-8. doi: 10.2106/00004623-200203000-00004. |
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| ID | Term |
|---|---|
| D003100 | Colles' Fracture |
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D000072039 | Fracture Dislocation |
| D004204 | Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| Finger Trap Traction | Procedure | Using a finger trap traction device in vertical suspension. After 10min reduction by dorsal pressure. |
|
| D014947 |
| Wounds and Injuries |
| D011885 | Radius Fractures |
| D050723 | Fractures, Bone |
| D001519 | Behavior |