Patellar DislocationNCT00551668
A Prospective, Randomized Study of Operative and Nonoperative Treatment for Primary Traumatic Patellar Dislocation
A study testing proximal patellar surgery and Nonoperative in people with Patellar Dislocation, run by Finnish Defense Forces.
Trial summary
The objective of this prospective, randomized cohort study was to evaluate the clinical results between operative and nonoperative treatment of primary patellar dislocation. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Patellar Dislocation
- What is being tested?
- proximal patellar surgery and Nonoperative
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 1998to Dec 2000
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An acute primary traumatic patellar dislocation
Who cannot join
- Previous dislocation or subluxation of the patella
- Pre-existing ipsilateral or contralateral knee pathology
- Previous knee trauma or patellar fracture.
About this study
Official title: A Prospective, Randomized Study of Operative and Nonoperative Treatment for Primary Traumatic Patellar Dislocation in Young Adults With a Median 7-Year Follow-Up
The objective of this prospective, randomized cohort study was to evaluate the clinical results between operative and nonoperative treatment of primary patellar dislocation.
Read the detailed description
There is no consensus about management of acute traumatic primary patellar dislocations in young physically active adults. Acute lateral patellar dislocation is a relatively common injury among young adults. Proper treatment for this condition has been researched for decades. However, there is a lack of prospective randomized studies to evaluate the different treatment options for traumatic primary patellar dislocations. Therefore a prospective, randomized study was designed with the aim to compare the outcome of operative versus nonoperative treatment of primary traumatic patellar dislocations in young adults.
- Conditions
- Patellar Dislocation
- Being tested
- proximal patellar surgery, Nonoperative
- Medical subject headings
- Patellar Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proximal patellar surgeryProcedure or surgery
Initial proximal patellar surgery
NonoperativeProcedure or surgery
Nonoperative without surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Operative Receives: Procedure: proximal patellar surgery |
| 2 | Experimental | Nonoperative Receives: Procedure: Nonoperative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of redislocations
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2007 (estimated)
- Study startJan 1998
- Study completionDec 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellar DislocationStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finnish Defense Forces
- Sponsor type
- Other government
- Investigators
- Harri Pihlajamäki, M.D., Ph.D., Study director, Centre for Military Medicine, Lahti, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00551668
- Sponsor's protocol ID
- R1199/8.1/D/II
- Status last verified
- Oct 2007
- First submitted
- 30 Oct 2007
- Last updated
- 31 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Study of Operative and Nonoperative Treatment for Primary Traumatic Patellar Dislocation in Young Adults With a Median 7-Year Follow-Up
- ClinicalTrials.gov ID
- NCT00551668
- Acronym / sponsor ID
- R1199/8.1/D/II
- Conditions
- Patellar Dislocation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Finnish Defense ForcesOther government
- Study start
- Jan 1998
- Study completion
- Dec 2000 (actual)
- First posted
- 31 Oct 2007 (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 objective of this prospective, randomized cohort study was to evaluate the clinical results between operative and nonoperative treatment of primary patellar dislocation.
Detailed description
There is no consensus about management of acute traumatic primary patellar dislocations in young physically active adults. Acute lateral patellar dislocation is a relatively common injury among young adults. Proper treatment for this condition has been researched for decades. However, there is a lack of prospective randomized studies to evaluate the different treatment options for traumatic primary patellar dislocations. Therefore a prospective, randomized study was designed with the aim to compare the outcome of operative versus nonoperative treatment of primary traumatic patellar dislocations in young adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: proximal patellar surgeryOperative |
| 2 | Experimental | Procedure: NonoperativeNonoperative |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- An acute primary traumatic patellar dislocation
Key exclusion criteria (3 listed)
- Previous dislocation or subluxation of the patella
- Pre-existing ipsilateral or contralateral knee pathology
- Previous knee trauma or patellar fracture.
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 |
|---|---|---|
| proximal patellar surgeryInitial proximal patellar surgery | Procedure or surgery | 1 |
| NonoperativeNonoperative without surgery | Procedure or surgery | 2 |
Primary outcome
Number of redislocations
Time frame: 7 years
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 31 Oct 2007.
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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.
Harri Pihlajamäki, M.D., Ph.D. study director
Centre for Military Medicine, Lahti, Finland
Questions about this trial
What is this clinical trial studying?
A study testing proximal patellar surgery and Nonoperative in people with Patellar Dislocation, run by Finnish Defense Forces.
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 3 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 31 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of redislocations (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Oct 2007.