Knee Pain SwellingNCT02096562
Knee Swelling Under Use of Compression Stockings After Outpatient Surgery
A study testing Patients use compression stockings for 10 days after surgery and normal therapy - no compression stockings in people with Knee Pain Swelling, run by University of Rostock at 1 site in Germany.
Trial summary
Outpatients who undergo knee surgery are designated two different clinical study groups. Group A receives common wrapping after surgery to the first postsurgical day and will be provided with compression stockings for the following 10 days, while group B only receives common wrapping and will not be provided with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Pain Swelling
- What is being tested?
- Patients use compression stockings for 10 days after surgery and normal therapy - no compression stockings
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2013to Mar 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years
- signed release form
Who cannot join
- deep vein thrombosis
- swelling caused by cardiac, venous or endocrine genesis
- dysfunction of the lymphatic system
- dysfunction of kidney or liver
- Use of water withholding medication
- massive adiposity
- cachexia
- epilepsy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Orthopädische Klinik und Poliklinik - Universitätsmedizin Rostock
Rostock, Meckenburg-Vorpommern, 18057
About this study
Official title: Prospective Randomized Assessment of Postsurgical Swelling Applying Compression Stockings vs. Conventional Wrapping After Outpatient Surgery
Outpatients who undergo knee surgery are designated two different clinical study groups. Group A receives common wrapping after surgery to the first postsurgical day and will be provided with compression stockings for the following 10 days, while group B only receives common wrapping and will not be provided with compression stockings.
The investigators are going to investigate the effect of compression stockings on postsurgical swelling and formation of edema on outpatients.
Read the detailed description
The investigators are planing on investigate the effect of compression stockings on postsurgical swelling and formation of edema. For this purpose the investigators devide outpatients who have undergone knee surgery to two different clinical study groups. Group A receives a common compression bandage after surgery to the first postsurgical day and receives compression stockings afterwards for the following 10 days, while Group B only receives a common compression bandage to the first postsurgical day. Group A will be instructed to wear compression stockings for 24 hours on the first two postsurgical day, afterwards at least for 8 hours a day.
Preoperatively the investigators are going to determine the volume and circumference of both legs using the Bodytronic 600 by Bauerfeind. Subsequently the measurement will be repeated on the first, forth and tenth postsurgical day. The investigators are going to measure the range of motion, also the patients of both groups will be asked to mark pain and tension on a visual analog scale and write down the amount of time they have been lying, sitting and standing each day. Group A will document the amount of time for how long they were wearing compression stockings each day.
- Conditions
- Knee Pain Swelling
- Being tested
- Patients use compression stockings for 10 days after surgery, normal therapy - no compression stockings
- Keywords
- knee welling outpatient compression stockings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients use compression stockings for 10 days after surgeryOther
patients wear compression stocking for 24 hours in the first 2 days after surgery and for at least 8 hours at day 3-10 after surgery
normal therapy - no compression stockingsOther
the patients receive the common therapy according to S2 guidelines
| Study group | Role | What they receive |
|---|---|---|
| B - No compression stockings | Placebo comparator | normal therapy - no compression stockings Receives: Other: normal therapy - no compression stockings |
| A - Use of compression stockings | Active comparator | Patients use compression stockings for 10 days after surgery Receives: Other: Patients use compression stockings for 10 days after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Swelling of lower Extremity (circumference in mm and volume in ml)
Measured: 10 days
Secondary outcomes (1)
Pain (visual analoge scale) and Range of Movement (degree of flexion)
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startJul 2013
- Primary completionMar 2015
- Study completionMar 2015
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 Knee Pain SwellingStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rostock
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastian Oye, University of Rostock
- Investigators
- Thomas Tischer, Prof. Dr., Study director, OUK Rostock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096562
- Sponsor's protocol ID
- A 2013-0083
- Status last verified
- May 2016
- First submitted
- 11 Nov 2013
- Last updated
- 24 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Tischer TS, Oye S, Lenz R, Kreuz P, Mittelmeier W, Bader R, Tischer T. Impact of compression stockings on leg swelling after arthroscopy - a prospective randomised pilot study. BMC Musculoskelet Disord. 2019 Apr 9;20(1):161. doi: 10.1186/s12891-019-2540-1.
PubMed 30967135
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Assessment of Postsurgical Swelling Applying Compression Stockings vs. Conventional Wrapping After Outpatient Surgery
- ClinicalTrials.gov ID
- NCT02096562
- Acronym / sponsor ID
- A 2013-0083
- Conditions
- Knee Pain Swelling
- Keywords
- knee welling outpatient compression stockings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 26 Mar 2014 (estimated)
- 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.
Outpatients who undergo knee surgery are designated two different clinical study groups. Group A receives common wrapping after surgery to the first postsurgical day and will be provided with compression stockings for the following 10 days, while group B only receives common wrapping and will not be provided with compression stockings.
The investigators are going to investigate the effect of compression stockings on postsurgical swelling and formation of edema on outpatients.
Detailed description
The investigators are planing on investigate the effect of compression stockings on postsurgical swelling and formation of edema. For this purpose the investigators devide outpatients who have undergone knee surgery to two different clinical study groups. Group A receives a common compression bandage after surgery to the first postsurgical day and receives compression stockings afterwards for the following 10 days, while Group B only receives a common compression bandage to the first postsurgical day. Group A will be instructed to wear compression stockings for 24 hours on the first two postsurgical day, afterwards at least for 8 hours a day.
Preoperatively the investigators are going to determine the volume and circumference of both legs using the Bodytronic 600 by Bauerfeind. Subsequently the measurement will be repeated on the first, forth and tenth postsurgical day. The investigators are going to measure the range of motion, also the patients of both groups will be asked to mark pain and tension on a visual analog scale and write down the amount of time they have been lying, sitting and standing each day. Group A will document the amount of time for how long they were wearing compression stockings each day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B - No compression stockings | Placebo comparator | Other: normal therapy - no compression stockingsnormal therapy - no compression stockings |
| A - Use of compression stockings | Active comparator | Other: Patients use compression stockings for 10 days after surgeryPatients use compression stockings for 10 days after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age > 18 years
- signed release form
Key exclusion criteria (8 listed)
- deep vein thrombosis
- swelling caused by cardiac, venous or endocrine genesis
- dysfunction of the lymphatic system
- dysfunction of kidney or liver
- Use of water withholding medication
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 |
|---|---|---|
| Patients use compression stockings for 10 days after surgerypatients wear compression stocking for 24 hours in the first 2 days after surgery and for at least 8 hours at day 3-10 after surgery | Other | A - Use of compression stockings |
| normal therapy - no compression stockingsthe patients receive the common therapy according to S2 guidelines | Other | B - No compression stockings |
Primary outcome
Amount of Swelling of lower Extremity (circumference in mm and volume in ml)
Time frame: 10 days
1 secondary outcome
Pain (visual analoge scale) and Range of Movement (degree of flexion)
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2016.
- Derived from this study: PubMed 30967135Tischer TS, Oye S, Lenz R, Kreuz P, Mittelmeier W, Bader R, Tischer T. Impact of compression stockings on leg swelling after arthroscopy - a prospective randomised pilot study. BMC Musculoskelet Disord. 2019 Apr 9;20(1):161. doi: 10.1186/s12891-019-2540-1.
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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.
Thomas Tischer, Prof. Dr. study director
OUK Rostock
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients use compression stockings for 10 days after surgery and normal therapy - no compression stockings in people with Knee Pain Swelling, run by University of Rostock 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 2 inclusion and 8 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: finished, as of the sponsor's last update on 24 May 2016. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Amount of Swelling of lower Extremity (circumference in mm and volume in ml) (time frame: 10 days). 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 NCT02096562, 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 24 May 2016.