Proximal Humerus FractureNCT05952622
Outcome After Plate Osteosynthesis of Proximal Humerus Fractures Using Continous Passive Motioning Therapy
A study testing Continuous passive motion therapy in people with Proximal Humerus Fracture, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Proximal Humerus Fracture
- What is being tested?
- Continuous passive motion therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2018to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with proximal humeral fracture treated with plate osteosynthesis during the enrollment period
- understanding of German language (written and oral)
- written informed consent of the patient or the legal guardian
Who cannot join
- patients not meeting the aforementioned criteria
- patients with the need of / or an already existing endoprosthesis
- patients with ipsilateral fracture of the distal radius
- patients with cerebral damage (contusio or commotio cerebri)
- patients with affection of the brachial plexus or nerve palsy
- non-compliance
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden
Dresden, Saxony, 01307
About this study
Official title: Comparison of Functional and Patient-reported Outcome Using Continuous Passive Motion in Rehabilitation After Plate Osteosynthesis of Proximal Humerus Fractures
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.
Read the detailed description
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.
- Conditions
- Proximal Humerus Fracture
- Being tested
- Continuous passive motion therapy
- Keywords
- proximal humerus fracture, plate osteosynthesis, rehabilitation, continuous passive motion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous passive motion therapyDevice
Patients will be supplied with a continuous passive motion device which will allow additional individual treatment of the affected shoulder for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Continuous passive motion therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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°
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment
Secondary outcomes (1)
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)
Measured: Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start1 Apr 2018
- Primary completion28 Feb 2022
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Proximal Humerus FractureStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952622
- Sponsor's protocol ID
- CPM
- Status last verified
- Jul 2023
- First submitted
- 19 Apr 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38802866
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Functional and Patient-reported Outcome Using Continuous Passive Motion in Rehabilitation After Plate Osteosynthesis of Proximal Humerus Fractures
- ClinicalTrials.gov ID
- NCT05952622
- Acronym / sponsor ID
- CPM
- Conditions
- Proximal Humerus Fracture
- Keywords
- proximal humerus fracture, plate osteosynthesis, rehabilitation, continuous passive motion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 19 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Standard rehabilitation protocol | No intervention | –Standard rehabilitation after surgical treatment consisting of initial immobilization followed by physiotherapy. |
| Rehabilitation protocol with CPM | Active comparator | Device: Continuous passive motion therapyAdditional treatment of patients with continuous passive motion after initial immobilization for 6 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- patients with proximal humeral fracture treated with plate osteosynthesis during the enrollment period
- understanding of German language (written and oral)
- written informed consent of the patient or the legal guardian
Key exclusion criteria (6 listed)
- patients not meeting the aforementioned criteria
- patients with the need of / or an already existing endoprosthesis
- patients with ipsilateral fracture of the distal radius
- patients with cerebral damage (contusio or commotio cerebri)
- patients with affection of the brachial plexus or nerve palsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous passive motion therapyPatients will be supplied with a continuous passive motion device which will allow additional individual treatment of the affected shoulder for 6 weeks. | Device | Rehabilitation protocol with CPM |
Primary outcome
Change in Range of Motion (ROM) after 6 weeks, 12 weeks and 1 year
Time frame: Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment
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°
Change of Disabilities of Arm, Shoulder and Hand Score (DASH) after 6 weeks, 12 weeks and 1 year
Time frame: Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment
Evaluation of the subjective function (patient reported outcome) using the DASH-Score, 0-100, best: 0, worst: 100
Change of Constant-Score (CSS) after 6 weeks, 12 weeks and 1 year
Time frame: Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment
Evaluation of the subjective function (patient reported outcome) using the Constant-Score, 0-100, best: 100, worst: 0
Change of Pain on visual analogue scale (VAS) after 6 weeks, 12 weeks and 1 year
Time frame: Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment
Evaluation of the subjective pain using a visual analogue scale, 0-10, best:0, worst: 10
Change of Subjective satisfaction with surgical treatment (SSV) after 6 weeks, 12 weeks and 1 year
Time frame: Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment
Evaluation of the subjective satisfaction using the subjective shoulder value, 0-100, best:100, worst: 0
1 secondary outcome
Influence of demographic factors upon rehabilitation process
Time frame: Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Derived from this study: PubMed 38802866Tille 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous passive motion therapy in people with Proximal Humerus Fracture, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Range of Motion (ROM) after 6 weeks, 12 weeks and 1 year (time frame: Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05952622, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.