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Patients suffering from a proximal humerus fracture treated with plate osteosynthesis will receive either regular aftercare (physiotherapy) or aftercare assisted with continous passive motion (physiotherapy + CPM). Change in functional and patient-reported outcome (PROM) over time will be evaluated and compared.
The investigators will conduct a prospective, monocentric study focusing on the rehabilitation process after surgical treatment of proximal humerus fractures. Patients treated with plate osteosynthesis and eligible to participate will be randomly assigend to either a regular rehabilitation protocol (immobilization and physiotherapy) or a rehabilitation protocol with the additional use of a continous passive motion device (immobilization, physiotherapy and CPM).
After 6 and 12 weeks as well as 1 year in a follow-up examination functional (range of motion) and patient-reported outcome (Disabilities of Arm, Shoulder and Hand Score [DASH], Constant-Score, pain on visual analogue scale, subjective satisfaction) will be evaluated. Results will be compared towards possible differences and effect of CPM therapy. In addition demographic factors (age, sex, BMI, etc.) and complications will be analysed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard rehabilitation protocol | No Intervention | Standard rehabilitation after surgical treatment consisting of initial immobilization followed by physiotherapy. | |
| Rehabilitation protocol with CPM | Active Comparator | Additional treatment of patients with continuous passive motion after initial immobilization for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous passive motion therapy | Device | Patients will be supplied with a continuous passive motion device which will allow additional individual treatment of the affected shoulder for 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Range of Motion (ROM) after 6 weeks, 12 weeks and 1 year | Objetive functional clinical result. Evaluation ot Motion of the shoulder in ° measured via goniometer. Physiological Abduction/Adduction: 180/0/40°, Anteversion/Retroversion 160/0/40°, external/internal rotation: 70/0/60° | Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment |
| Change of Disabilities of Arm, Shoulder and Hand Score (DASH) after 6 weeks, 12 weeks and 1 year | Evaluation of the subjective function (patient reported outcome) using the DASH-Score, 0-100, best: 0, worst: 100 | Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment |
| Change of Constant-Score (CSS) after 6 weeks, 12 weeks and 1 year | Evaluation of the subjective function (patient reported outcome) using the Constant-Score, 0-100, best: 100, worst: 0 | Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment |
| Change of Pain on visual analogue scale (VAS) after 6 weeks, 12 weeks and 1 year | Evaluation of the subjective pain using a visual analogue scale, 0-10, best:0, worst: 10 | Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment |
| Change of Subjective satisfaction with surgical treatment (SSV) after 6 weeks, 12 weeks and 1 year | Evaluation of the subjective satisfaction using the subjective shoulder value, 0-100, best:100, worst: 0 | Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Influence of demographic factors upon rehabilitation process | Evaluation of the underlying demographic factors (gender, age, BMI) and whether these affect the functional and patient-reported outcome (univariate regressional analysis) | Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden | Dresden | Saxony | 01307 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38802866 | Derived | Tille E, Lorenz F, Beyer F, Schlussler A, Biewener A, Nowotny J. Early functional improvements using continuous passive motion therapy after angular-stable plate osteosynthesis of proximal humerus fractures - results of a prospective, randomized trial. J Orthop Surg Res. 2024 May 28;19(1):313. doi: 10.1186/s13018-024-04804-x. |
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| ID | Term |
|---|---|
| D015915 | Motion Therapy, Continuous Passive |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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Patients are assigned to one of two rehabilitation protocols consisting of either A: initial immobilization followed by physiotherapy or B: initial immobilization followed by physiotherapy and additional continuous passive motion therapy
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Patients are randomly assigend, masking is not possible.
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| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D026201 | Musculoskeletal Manipulations |