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Recruitment decline due to change in clinical practice to less surgery for the fractures of interest
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| Name | Class |
|---|---|
| Finnish Institute for Health and Welfare | OTHER_GOV |
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Open reduction and locking plate osteosynthesis is a commonly used and well-accepted treatment for displaced fractures of the proximal humerus. The shoulders tend to end stiff despite intensive rehabilitation, limiting the function of the upper extremity and decreasing the quality of life. The accepted postoperative mobilisation protocol includes passive exercises until six weeks postoperatively and active range of motion exercises after that. There is good evidence that conservatively treated fractures of the same site heal better and faster if mobilised immediately. The study compares "standard mobilisation" versus "immmediate mobilisation" in a prospective, randomized, controlled trial in order to find the optimal time-frame for physiotherapy to produce best possible results. Outcome measures are assessed at specific time points after the operation and comparisons between groups are made to follow the rate of recovery and end results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate mobilisation | Experimental |
| |
| Standard mobilisation | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate mobilisation after locking-plate osteosynthesis | Procedure | Immediate passive range of motion exercises are begun postoperatively, after 3 weeks, active unloaded mobilisation begins after three weeks and active, loaded use is allowed 6 weeks postoperatively. Surgical procedure is open reduction of the fracture and internal fixation of the fracture using a locking plate using standard deltopectoral approach and AO principles in fracture management. |
| Measure | Description | Time Frame |
|---|---|---|
| Disablities of Arm, Hand and Shoulder | Validated patient-reported upper extremity function scale | 3 weeks |
| Disablities of Arm, Hand and Shoulder | Validated patient-reported upper extremity function scale | 6 weeks |
| Disablities of Arm, Hand and Shoulder | Validated patient-reported upper extremity function scale | 3 months |
| Disablities of Arm, Hand and Shoulder | Validated patient-reported upper extremity function scale | 6 months |
| Disablities of Arm, Hand and Shoulder | Validated patient-reported upper extremity function scale | 1 year |
| Disablities of Arm, Hand and Shoulder | Validated patient-reported upper extremity function scale | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Constant Score | subjective and objective shoulder score | 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years |
| Simple Shoulder Test (SST) | another shoulder score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tuomas Lähdeoja, MD | Helsinki University Central Hospital | Principal Investigator |
| Mika Paavola, MD, PhD | Helsinki University Central Hospital | Study Director |
| Jarkko Pajarinen, MD, PhD | Helsinki University Central Hospital | Study Director |
| Seppo Koskinen | Helsinki University Central Hospital | Study Chair |
| Antti Malmivaara, MD, PhD | Finnish Institute for Health and Welfare | Study Chair |
| Reijo Sund, MD, PhD | Finnish Institute for Health and Welfare | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Töölö Hospital, Helsinki University Central Hospital | Helsinki | 00029 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35727196 | Derived | Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5. |
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|
| Standard mobilisation after locking plate osteosynthesis | Procedure | Immediately postoperatively the arm is held in a sling, active mobilisation of healthy joints and pendel exercises are befun. Passive range of motion exercises of the shoulder are begun 3 weeks postoperatively. Active mobilisation begins after six weeks. Surgical procedure is open reduction of the fracture and internal fixation of the fracture using a locking plate using standard deltopectoral approach and AO principles in fracture management. |
|
| Osteosynthesis with a locking plate (Philos) | Device | Standard open reduction and internal fixation using a deltopectoral approach. Fracture fixation is done using a locking plate (Philos, Synthes) following the AO principles of fracture management. |
|
| 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years |
| Pain in rest and motion (2 different values) | Numeric rating scale 0-10 | 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years |
| Subjective satisfaction | Patient reported, Numeric Rating Scale 0-10 | 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years |
| Quality of Life | Using the 15D instrument | 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years |
| Complications | Complications of surgery and postoperative phase | 3 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years |
| ID | Term |
|---|---|
| D006810 | Humeral Fractures |
| ID | Term |
|---|---|
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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| ID | Term |
|---|---|
| D005593 | Fracture Fixation, Internal |
| ID | Term |
|---|---|
| D005592 | Fracture Fixation |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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