Outcome After Plate Osteosynthesis of Proximal Humerus Fractures Using Continous Passive Motioning Therapy

July 17, 2023 updated by: Technische Universität Dresden

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
103

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Saxonia
      • Dresden, Saxonia, Germany, 01307
        • University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Standard rehabilitation protocol
Standard rehabilitation after surgical treatment consisting of initial immobilization followed by physiotherapy.
Active Comparator: Rehabilitation protocol with CPM
Additional treatment of patients with continuous passive motion after initial immobilization for 6 weeks.
Device: Continuous passive motion therapy
Patients will be supplied with a continuous passive motion device which will allow additional individual treatment of the affected shoulder for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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°
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
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
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
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
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
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
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
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
Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Influence of demographic factors upon rehabilitation process
Time Frame: Time of Follow-Up assesment, 6 and 12weeks as well as 1year after surgical treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Technische Universität Dresden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CPM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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