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| Name | Class |
|---|---|
| The Swedish Association for Survivors of Accident and Injury | UNKNOWN |
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A 10-year follow up of a fusion of two earlier published randomized controlled trials. 203 patients with displaced distal radius fractures were randomized to surgery with a volar locking plate or external fixation.
Follow up includes PROMs (DASH, PRWE, EQ-5D), radiological assesment and objective tests by a hand occupational therapist (ROM, grip strength).
Previous Clinical trials registration for the original studies this long-term follow up is a continuation on: NCT00989222, NCT01034943, NCT01035359
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Volar Locking Plate | Experimental | Surgery with volar locking plate |
|
| External fixation | Active Comparator | Surgery with external fixation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Volar locking plate | Procedure | Volar locking plate is the intervention |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Disability of the arm shoulder and hand (DASH) | PROM Patient Rated outcome Measurement. A 30-item questionnaire to assess musculoskeletal disorders in upper limbs. It also has two 4-items optional modules to assess function and symptoms in athletes, artists and workers. Item response range from 1 (no difficult) to 5 (unable). The total score ranges from 0 (no disability) to 100 (most severe disability). | 10 years after initial surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Patient rated wrist evaluation (PRWE) | A patient rated outcome measurement(PROM) a subjective test of function by a 15-item questionnaire. PRWE is specific for wrist evaluation. It consists of two subscales - pain and function. Total score ranges from 0 (no disability) to 100 (severe disability) | 10 years after initial surgery |
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Inclusion Criteria:
DS center
SÖS center
Exclusion Criteria:
DS center:
SÖS center:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olof Sköldenberg, Professor | Contact | 0046812357245 | olof.skoldenberg@regionstockholm.se | |
| Sara Severin, MD | Contact | 0046812356504 | sara.l.severin@regionstockholm.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, Division of Ortopeadics | Recruiting | Stockholm | 182 88 | Sweden |
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| external fixation |
| Procedure |
surgery with external fixation |
|
| Radiological assesment |
x-ray of both wrists, AP and lateral. Assessing radial inclination, dorsal tilt, ulnar variance. Osteoarthritis of the radioulnar joint and DRU-joint, fractures in carpus/ulna. VISI/DISI and SL-dissociation. |
| 10 years after initial surgery |
| Objective tests of range of motion (ROM) | pronation and supination, ulnar- and radial deviation, volar flexion and doral extension of both wrists with a goniometer, units will be degrees. | 10 years after initial surgery |
| Journal investigation | A journal assesment to find complications as infections, reoperations, CRPS, nerv injuries. | 0-10 years after initial surgery |
| EQ-5D | A health related quality of life questionnaire. EQ-5D is the correct name and not an abbreviation. 5 dimensions of health is assessed (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) in three levels (no problems/some or moderate problems/extreme problems). The responses of EQ-5D can be converted to a singel number - a index value and compared with a value set. The index value reflects how good or bad the health statues is. There is also a visual analogue scale on overall health with the scale 0 (worst imaginable health state) to 100 (best imaginable health state). | 10 years after initial surgery |
| Objective test of grip strength | Test of grip strength by GRIPPIT units is Newton. Grip strength will be measured bilateral and presented as maximum, mean and value after 10 seconds. | 10 year after initial surgery. |
| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| D013708 | Tendon Injuries |
| D013530 | Surgical Wound Infection |
| D012019 | Reflex Sympathetic Dystrophy |
| D002422 | Causalgia |
| D004204 | Joint Dislocations |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020918 | Complex Regional Pain Syndromes |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009437 | Neuralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D016267 | External Fixators |
| ID | Term |
|---|---|
| D009984 | Orthopedic Fixation Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
| D053831 | Surgical Fixation Devices |
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