Hip DisabilityNCT00716729
Development of Outcome-measures for Physically Active Patients With Hip and Groin Pain
An observational study of Hip Disability and Groin Disability, run by Amager Hospital at 1 site in Denmark.
Trial summary
The aim of this study is to develop an evaluative questionnaire, to evaluate patients with hip and groin disability, and a strength measurement for the hip, for patients with hip and groin disability. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hip Disability, Groin Disability
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2009to Oct 2010
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with hip and/groin pain for more than 8 weeks
Who may be able to join
- Hip and/groin pain more than 6 weeks
- Physically active
Who cannot join
- Systemic diseases
- Physically inactive
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to develop an evaluative questionnaire, to evaluate patients with hip and groin disability, and a strength measurement for the hip, for patients with hip and groin disability.
Both measurement instrument are aimed for evaluating the natural course and different treatment modalities in patients with hip and groin disability.
- Conditions
- Hip Disability, Groin Disability
- Keywords
- Questionnaire, Hip, Groin, Disability, Strength, To develop two new outcome measures for patients with hip and groin disability
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 |
|---|---|---|
| Pateints with longstanding hip and/groin pain | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported questionnaire
Measured: 1-2 years
Secondary outcomes (1)
Strength measurement for the hip
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startJul 2009
- Primary completionJun 2010
- Study completionOct 2010
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 Hip DisabilityStudies 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
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amager Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00716729
- Sponsor's protocol ID
- H-C-2007-0129
- Status last verified
- Jul 2008
- First submitted
- 15 Jul 2008
- Last updated
- 19 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Thorborg K, Holmich P, Christensen R, Petersen J, Roos EM. The Copenhagen Hip and Groin Outcome Score (HAGOS): development and validation according to the COSMIN checklist. Br J Sports Med. 2011 May;45(6):478-91. doi: 10.1136/bjsm.2010.080937.
PubMed 21478502
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Outcome-measures for Physically Active Patients With Hip and Groin Pain
- ClinicalTrials.gov ID
- NCT00716729
- Acronym / sponsor ID
- H-C-2007-0129
- Conditions
- Hip Disability, Groin Disability
- Keywords
- Questionnaire, Hip, Groin, Disability, Strength, To develop two new outcome measures for patients with hip and groin disability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Amager HospitalUniversity, hospital or other
- Collaborators
- Lundbeck Foundation
- Study start
- Jul 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 16 Jul 2008 (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.
The aim of this study is to develop an evaluative questionnaire, to evaluate patients with hip and groin disability, and a strength measurement for the hip, for patients with hip and groin disability.
Both measurement instrument are aimed for evaluating the natural course and different treatment modalities in patients with hip and groin disability.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pateints with longstanding hip and/groin pain | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hip and/groin pain for more than 8 weeks
Key inclusion criteria (2 listed)
- Hip and/groin pain more than 6 weeks
- Physically active
Key exclusion criteria (2 listed)
- Systemic diseases
- Physically inactive
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
Patient reported questionnaire
Time frame: 1-2 years
1 secondary outcome
Strength measurement for the hip
Time frame: 1 year
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 Oct 2010.
- Derived from this study: PubMed 21478502Thorborg K, Holmich P, Christensen R, Petersen J, Roos EM. The Copenhagen Hip and Groin Outcome Score (HAGOS): development and validation according to the COSMIN checklist. Br J Sports Med. 2011 May;45(6):478-91. doi: 10.1136/bjsm.2010.080937.
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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?
An observational study of Hip Disability and Groin Disability, run by Amager 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 Oct 2010. 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?
Patient reported questionnaire (time frame: 1-2 years). 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 NCT00716729, 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 Oct 2010.