ArthroplastyNCT01248039
Preoperative Pain, Function, and Activity for Total Hip and Knee Arthroplasty Patients
An observational study of Arthroplasty, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
This study wish to show if the preoperative level of pain, function or activity for hip and knee arthroplasty patients has any predictive value of the time it takes to fulfill the well-defined discharge criteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2011to Jul 2012
- Phase
- Observational
- 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
Study population: Concesutive hip and knee arthroplasty patients from a department of orthopaedic surgery
Who may be able to join
- Total hip arthroplasty patients
- Total knee arthroplasty patients
Who cannot join
- Inability to speak and understand Danish
- Inability to perform the functional measurements due to other conditions
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Surgery, Univerity Hospital at Hvidovre
Hvidovre, Hvidovre, 2650
About this study
Official title: The Influence of Preoperative Pain, Function, and Activity on Time to Fulfill Discharge Criteria for Total Hip and Knee Arthroplasty Patients
This study wish to show if the preoperative level of pain, function or activity for hip and knee arthroplasty patients has any predictive value of the time it takes to fulfill the well-defined discharge criteria.
Read the detailed description
The investigators would like to be able to identify those patients, for whom it will take longest time to fulfill the discharge criteria. With this knowledge the investigators will be able to initiate sufficient treatment already before operation.
- Conditions
- Arthroplasty
- Keywords
- Muscle strength, functional performance, joint replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Total arthroplasty | Patients with osteoarthrosis going for hip or knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leg muscles strength
Maximal muscle force tested for one leg at a time in a Power Rig Mashine
Measured: 7 months
Secondary outcomes (1)
Functional performance
Tested by: Timed Up \& Go test, 10 meter fast speed walking test
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionJul 2012
- Study completionJul 2012
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 ArthroplastyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck Foundation
- Responsible party
- Principal investigator, Bente Holm, Hvidovre University Hospital
- Investigators
- Bente Holm, MSc, Principal investigator, The Lundbeckcenter for hip and knee surgery, University Hospital at Hvidovre, Kettegaard Allé 30, DK-2650 hvidovre, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01248039
- Sponsor's protocol ID
- H-4-2010-FSP2
- Other IDs
- PRE-THA-TKA
- Status last verified
- Jul 2012
- First submitted
- 24 Nov 2010
- Last updated
- 19 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Holm B, Bandholm T, Lunn TH, Husted H, Aalund PK, Hansen TB, Kehlet H. Role of preoperative pain, muscle function, and activity level in discharge readiness after fast-track hip and knee arthroplasty. Acta Orthop. 2014 Sep;85(5):488-92. doi: 10.3109/17453674.2014.934186. Epub 2014 Jun 23.
PubMed 24954491
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Preoperative Pain, Function, and Activity on Time to Fulfill Discharge Criteria for Total Hip and Knee Arthroplasty Patients
- ClinicalTrials.gov ID
- NCT01248039
- Acronym / sponsor ID
- H-4-2010-FSP2
- Conditions
- Arthroplasty
- Keywords
- Muscle strength, functional performance, joint replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Lundbeck Foundation
- Study start
- Jan 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 25 Nov 2010 (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.
This study wish to show if the preoperative level of pain, function or activity for hip and knee arthroplasty patients has any predictive value of the time it takes to fulfill the well-defined discharge criteria.
Detailed description
The investigators would like to be able to identify those patients, for whom it will take longest time to fulfill the discharge criteria. With this knowledge the investigators will be able to initiate sufficient treatment already before operation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total arthroplasty | – | –Patients with osteoarthrosis going for hip or knee arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Concesutive hip and knee arthroplasty patients from a department of orthopaedic surgery
Key inclusion criteria (2 listed)
- Total hip arthroplasty patients
- Total knee arthroplasty patients
Key exclusion criteria (2 listed)
- Inability to speak and understand Danish
- Inability to perform the functional measurements due to other conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Leg muscles strength
Time frame: 7 months
Maximal muscle force tested for one leg at a time in a Power Rig Mashine
1 secondary outcome
Functional performance
Time frame: 7 months
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 19 Jul 2012.
- Derived from this study: PubMed 24954491Holm B, Bandholm T, Lunn TH, Husted H, Aalund PK, Hansen TB, Kehlet H. Role of preoperative pain, muscle function, and activity level in discharge readiness after fast-track hip and knee arthroplasty. Acta Orthop. 2014 Sep;85(5):488-92. doi: 10.3109/17453674.2014.934186. Epub 2014 Jun 23.
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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.
Bente Holm, MSc principal investigator
The Lundbeckcenter for hip and knee surgery, University Hospital at Hvidovre, Kettegaard Allé 30, DK-2650 hvidovre, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty, run by Hvidovre University Hospital at 1 site in Denmark.
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 2 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 19 Jul 2012. 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 Denmark. 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?
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?
Leg muscles strength (time frame: 7 months). 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 NCT01248039, 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 2012.