Hip PathologyNCT02495701
Complications Related to Arthroscopic Surgery of the Hip - a Prospective Cohort Study
An observational study of Hip Pathology and Femoracetabular Impingement, run by University of Aarhus at 1 site in Denmark.
Trial summary
Arthroscopic hip surgery is performed with traction on the leg to allow the surgeon to perform the surgical procedure. A retrospective study has described neuropraxia, ankle joint pain and a skin burn after surgery (1). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hip Pathology, Femoracetabular Impingement
- What is being tested?
- Hip arthroscopic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 220 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2015to 15 Dec 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing hip arthroscopic surgery at Horsens Hospital, Denmark
Who may be able to join
- All patients undergoing hip arthroscopic surgery at Horsens Hospital, Denmark, during one year.
Who cannot join
- Non
Trial locations and contacts
1 site in 1 country.
About this study
Arthroscopic hip surgery is performed with traction on the leg to allow the surgeon to perform the surgical procedure. A retrospective study has described neuropraxia, ankle joint pain and a skin burn after surgery (1). Moreover, it has been described that surgeons performing the procedure have a learning curve related to the number of complications described postoperatively. At the investigators' institution, hip arthroscopies have been performed since 2010 and the 3 surgeons have 4-12 years of experience. During the past years, changes have been made to secure the best possible comfort for the patient during the arthroscopic procedure. Hence, there is a rationale for investigating complications after hip arthroscopy in a setting that is less affected by the surgeon's learning curve and with the patient comfort in focus.
- Conditions
- Hip Pathology, Femoracetabular Impingement
- Being tested
- Hip arthroscopic surgery
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip arthroscopic surgeryProcedure or surgery
Hip arthroscopic surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients having Hip arthroscopic surgery Receives: Procedure: Hip arthroscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale-pain of the knee
Measured: Three months after surgery
Visual analog scale-pain of the ankle
Measured: Three months after surgery
Number of patients reporting numbness
Measured: Three months after surgery
Number of adverse events
Infections, deep vein thrombosis, caput femoris necrosis, fracture, nerve injuries
Measured: From surgery to one year after surgery
Secondary outcomes (13)
Visual analog scale-pain of the hip/groin at rest
Measured: Two weeks after surgery
Visual analog scale-pain of the hip/groin at rest
Measured: Three months after surgery
Visual analog scale-pain of the hip/groin after activities
Measured: Two weeks after surgery
Visual analog scale-pain of the hip/groin after activities
Measured: Three months after surgery
Visual analog scale-pain of the knee
Measured: Two weeks after surgery
Visual analog scale-pain of the ankle
Measured: Two weeks after surgery
Number of patients reporting numbness
Measured: From surgery to two weeks after surgery
Number of patients reporting sexual dysfunction
Measured: From surgery to three months after surgery
Number of patients and areas where patients report pain (Pain drawings)
Measured: Two weeks after surgery
Number of patients and areas where patients report pain (Pain drawings)
Measured: Three months after surgery
Number of patients reporting superficial skin abrasion
Measured: From surgery to two weeks after surgery
Visual analog scale-pain of the back
Measured: Two weeks after surgery
Visual analog scale-pain of the back
Measured: Three months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study start1 Oct 2015
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Why it stopped: main outcome could not be ekstracted from database
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 PathologyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Horsens Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495701
- Sponsor's protocol ID
- 1-16-02-260-15
- Status last verified
- Jan 2024
- First submitted
- 1 Jun 2015
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Park MS, Yoon SJ, Kim YJ, Chung WC. Hip arthroscopy for femoroacetabular impingement: the changing nature and severity of associated complications over time. Arthroscopy. 2014 Aug;30(8):957-63. doi: 10.1016/j.arthro.2014.03.017. Epub 2014 May 14.
PubMed 24835839
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complications Related to Arthroscopic Surgery of the Hip - a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02495701
- Acronym / sponsor ID
- 1-16-02-260-15
- Conditions
- Hip Pathology, Femoracetabular Impingement
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: main outcome could not be ekstracted from database
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Horsens Hospital
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 13 Jul 2015 (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.
Arthroscopic hip surgery is performed with traction on the leg to allow the surgeon to perform the surgical procedure. A retrospective study has described neuropraxia, ankle joint pain and a skin burn after surgery (1). Moreover, it has been described that surgeons performing the procedure have a learning curve related to the number of complications described postoperatively. At the investigators' institution, hip arthroscopies have been performed since 2010 and the 3 surgeons have 4-12 years of experience. During the past years, changes have been made to secure the best possible comfort for the patient during the arthroscopic procedure. Hence, there is a rationale for investigating complications after hip arthroscopy in a setting that is less affected by the surgeon's learning curve and with the patient comfort in focus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Procedure: Hip arthroscopic surgeryPatients having Hip arthroscopic surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing hip arthroscopic surgery at Horsens Hospital, Denmark
Key inclusion criteria (1 listed)
- All patients undergoing hip arthroscopic surgery at Horsens Hospital, Denmark, during one year.
Key exclusion criteria (1 listed)
- Non
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 |
|---|---|---|
| Hip arthroscopic surgeryHip arthroscopic surgery | Procedure or surgery | Patients |
Primary outcome
Visual analog scale-pain of the knee
Time frame: Three months after surgery
Visual analog scale-pain of the ankle
Time frame: Three months after surgery
Number of patients reporting numbness
Time frame: Three months after surgery
Number of adverse events
Time frame: From surgery to one year after surgery
Infections, deep vein thrombosis, caput femoris necrosis, fracture, nerve injuries
13 secondary outcomes
Visual analog scale-pain of the hip/groin at rest
Time frame: Two weeks after surgery
Visual analog scale-pain of the hip/groin at rest
Time frame: Three months after surgery
Visual analog scale-pain of the hip/groin after activities
Time frame: Two weeks after surgery
Visual analog scale-pain of the hip/groin after activities
Time frame: Three months after surgery
Visual analog scale-pain of the knee
Time frame: Two weeks after surgery
Visual analog scale-pain of the ankle
Time frame: Two weeks after surgery
Number of patients reporting numbness
Time frame: From surgery to two weeks after surgery
Number of patients reporting sexual dysfunction
Time frame: From surgery to three months after surgery
Number of patients and areas where patients report pain (Pain drawings)
Time frame: Two weeks after surgery
Number of patients and areas where patients report pain (Pain drawings)
Time frame: Three months after surgery
Number of patients reporting superficial skin abrasion
Time frame: From surgery to two weeks after surgery
Visual analog scale-pain of the back
Time frame: Two weeks after surgery
Visual analog scale-pain of the back
Time frame: Three months after surgery
Results and safety
The study was stopped early (reason given: main outcome could not be ekstracted from database). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Background: PubMed 24835839Park MS, Yoon SJ, Kim YJ, Chung WC. Hip arthroscopy for femoroacetabular impingement: the changing nature and severity of associated complications over time. Arthroscopy. 2014 Aug;30(8):957-63. doi: 10.1016/j.arthro.2014.03.017. Epub 2014 May 14.
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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 Pathology and Femoracetabular Impingement, run by University of Aarhus 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 24 Jan 2024. 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 was stopped early (reason given: main outcome could not be ekstracted from database). 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?
Visual analog scale-pain of the knee (time frame: Three months after surgery). The study lists 4 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 NCT02495701, 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 Jan 2024.