Patellar DislocationNCT01344915
Restricted vs. Free Knee Range Of Motion For Primary Traumatic Patellar Dislocation
A study testing Locked knee brace in people with Patellar Dislocation, run by Tampere University Hospital at 1 site in Finland.
Trial summary
Knee immobilization in near extension has been proposed as a nonoperative treatment for primary traumatic patellar dislocation, although there exist no prospective studies regarding the method of immobilization. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Patellar Dislocation
- What is being tested?
- Locked knee brace
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteFinland
- Study dates
- Dec 2005to Jun 2011
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A primary (first-time) patellar dislocation verified by clinical examination
- Signs of patellar dislocation in MRI
Who cannot join
- anyone with previous patellar instability
- osteochondral fracture requiring surgery
- associated knee injuries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RESTRICTED VS. FREE KNEE RANGE OF MOTION FOR PRIMARY TRAUMATIC PATELLAR DISLOCATION: A PROSPECTIVE RANDOMIZED STUDY
Knee immobilization in near extension has been proposed as a nonoperative treatment for primary traumatic patellar dislocation, although there exist no prospective studies regarding the method of immobilization. The objective of this prospective randomized study was to compare the clinical outcome after nonoperative treatment with restricted vs. free range of motion (ROM) for primary traumatic patellar dislocation.
- Conditions
- Patellar Dislocation
- Being tested
- Locked knee brace
- Keywords
- Patella, Knee, Brace
- Medical subject headings
- Patellar Dislocation, Patella Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Locked knee braceProcedure or surgery
Locked knee braceProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Knee brace | Active comparator | Not described Receives: Procedure: Locked knee brace |
| Locked knee brace | Active comparator | Not described Receives: Procedure: Locked knee brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patellar redislocation
The number of patients with patellar redislocation after initial treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startDec 2005
- Primary completionJan 2007
- Study completionJun 2011 (estimated)
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 Patellar DislocationStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Petri J Sillanpää, MD PhD, Principal investigator, Tampere University Hospital, Department of Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344915
- Sponsor's protocol ID
- PATRCTFIN
- Status last verified
- Jan 2005
- First submitted
- 28 Apr 2011
- Last updated
- 2 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Honkonen EE, Sillanpaa PJ, Reito A, Maenpaa H, Mattila VM. A Randomized Controlled Trial Comparing a Patella-Stabilizing, Motion-Restricting Knee Brace Versus a Neoprene Nonhinged Knee Brace After a First-Time Traumatic Patellar Dislocation. Am J Sports Med. 2022 Jun;50(7):1867-1875. doi: 10.1177/03635465221090644. Epub 2022 Apr 19.
PubMed 35438588
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESTRICTED VS. FREE KNEE RANGE OF MOTION FOR PRIMARY TRAUMATIC PATELLAR DISLOCATION: A PROSPECTIVE RANDOMIZED STUDY
- ClinicalTrials.gov ID
- NCT01344915
- Acronym / sponsor ID
- PATRCTFIN
- Conditions
- Patellar Dislocation
- Keywords
- Patella, Knee, Brace
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jun 2011 (estimated)
- First posted
- 29 Apr 2011 (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.
Knee immobilization in near extension has been proposed as a nonoperative treatment for primary traumatic patellar dislocation, although there exist no prospective studies regarding the method of immobilization. The objective of this prospective randomized study was to compare the clinical outcome after nonoperative treatment with restricted vs. free range of motion (ROM) for primary traumatic patellar dislocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Knee brace | Active comparator | Procedure: Locked knee brace |
| Locked knee brace | Active comparator | Procedure: Locked knee brace |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- A primary (first-time) patellar dislocation verified by clinical examination
- Signs of patellar dislocation in MRI
Key exclusion criteria (3 listed)
- anyone with previous patellar instability
- osteochondral fracture requiring surgery
- associated knee injuries
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 |
|---|---|---|
| Locked knee brace | Procedure or surgery | Knee brace |
| Locked knee brace | Procedure or surgery | Locked knee brace |
Primary outcome
Patellar redislocation
The number of patients with patellar redislocation after initial treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2011.
- Derived from this study: PubMed 35438588Honkonen EE, Sillanpaa PJ, Reito A, Maenpaa H, Mattila VM. A Randomized Controlled Trial Comparing a Patella-Stabilizing, Motion-Restricting Knee Brace Versus a Neoprene Nonhinged Knee Brace After a First-Time Traumatic Patellar Dislocation. Am J Sports Med. 2022 Jun;50(7):1867-1875. doi: 10.1177/03635465221090644. Epub 2022 Apr 19.
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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.
Petri J Sillanpää, MD PhD principal investigator
Tampere University Hospital, Department of Orthopaedic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Locked knee brace in people with Patellar Dislocation, run by Tampere University Hospital at 1 site in Finland.
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 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: status not confirmed, as of the sponsor's last update on 2 May 2011. 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 Finland. 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?
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?
Patellar redislocation. 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 NCT01344915, 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 2 May 2011; AzTrials last refreshed its copy on 6 Nov 2026.