Intra-articular Knee FracturesNCT00591929
Use of Continuous Passive Motion in the Post-Operative Treatment of Intra-articular Knee Fractures
A study testing Continuous Passive Motion in people with Intra-articular Knee Fractures, run by Prisma Health-Upstate at 1 site in United States.
Trial summary
Decreased range of motion is common after fractures around the knee and can impact a patient's ability to perform activities of daily living such as rising from a seated position or getting in and out of a bathtub. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Intra-articular Knee Fractures
- What is being tested?
- Continuous Passive Motion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Mar 2013
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- If the patient has an intra-articular distal femur or proximal tibia fracture
- Independent ambulatory prior to injury
- No previous knee injury limiting motion
Who cannot join
- If the patients range of motion was decreased prior to injury (ex. Osteoarthritis, previous knee fracture or injury)
- Any contraindication to CPM (concomitant hip or ankle fracture)
- Open physis of tibia or distal femur
- Pathological Fracture
- Compartment Syndrome
- Neurovascular injury
Show all 12Show fewer
- Fracture due to gunshot wound
- Greater than 21 days from fracture to definitive open reduction and internal fixation
- Fractures treated with definitive external fixation
- Open fractures
- Extensor mechanism injuries
- Likely problems in the judgment of the investigator with maintaining follow-up
Trial locations and contacts
1 site in 1 country.
United States1 site
Greenville Hospital System Univeristy Medical Center
Greenville, South Carolina, 29605
About this study
Decreased range of motion is common after fractures around the knee and can impact a patient's ability to perform activities of daily living such as rising from a seated position or getting in and out of a bathtub. A continuous passive motion (CPM) machine is a machine that continuously moves a joint (such as the knee) without the patient having to use the muscles in his/her leg. A goal of this therapy is to maintain as much motion as possible following this injury. This study is a randomized, prospective study to evaluate the effectiveness of CPM in maintaining knee range of motion following open reduction and internal fixation (ORIF) of fractures around the knee
- Conditions
- Intra-articular Knee Fractures
- Being tested
- Continuous Passive Motion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Passive MotionOther
at least 48 hours of continuous passive motion following ORIF of fractures around the knee
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | No Continuous passive motion following ORIF of fractures around the knee |
| 2 | Active comparator | Continuous Passive Motion following ORIF of fractures around the knee Receives: Other: Continuous Passive Motion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Range of Motion
Measured: 48 hours, 2 weeks, 6 weeks, 3 months, 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startDec 2006
- Primary completionMar 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-articular Knee FracturesStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopaedic Trauma Association
- Responsible party
- Sponsor
- Investigators
- Kyle J. Jeray, MD, Principal investigator, Greenville Hospital System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00591929
- Sponsor's protocol ID
- GHS-12-06-03
- Status last verified
- Mar 2013
- First submitted
- 28 Dec 2007
- Last updated
- 12 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Continuous Passive Motion in the Post-Operative Treatment of Intra-articular Knee Fractures
- ClinicalTrials.gov ID
- NCT00591929
- Acronym / sponsor ID
- GHS-12-06-03
- Conditions
- Intra-articular Knee Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Collaborators
- Orthopaedic Trauma Association
- Study start
- Dec 2006
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 11 Jan 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.
Decreased range of motion is common after fractures around the knee and can impact a patient's ability to perform activities of daily living such as rising from a seated position or getting in and out of a bathtub. A continuous passive motion (CPM) machine is a machine that continuously moves a joint (such as the knee) without the patient having to use the muscles in his/her leg. A goal of this therapy is to maintain as much motion as possible following this injury. This study is a randomized, prospective study to evaluate the effectiveness of CPM in maintaining knee range of motion following open reduction and internal fixation (ORIF) of fractures around the knee
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –No Continuous passive motion following ORIF of fractures around the knee |
| 2 | Active comparator | Other: Continuous Passive MotionContinuous Passive Motion following ORIF of fractures around the knee |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- If the patient has an intra-articular distal femur or proximal tibia fracture
- Independent ambulatory prior to injury
- No previous knee injury limiting motion
Key exclusion criteria (12 listed)
- If the patients range of motion was decreased prior to injury (ex. Osteoarthritis, previous knee fracture or injury)
- Any contraindication to CPM (concomitant hip or ankle fracture)
- Open physis of tibia or distal femur
- Pathological Fracture
- Compartment Syndrome
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 |
|---|---|---|
| Continuous Passive Motionat least 48 hours of continuous passive motion following ORIF of fractures around the knee | Other | 2 |
Primary outcome
Knee Range of Motion
Time frame: 48 hours, 2 weeks, 6 weeks, 3 months, 6 months and 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 12 Mar 2013.
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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.
Kyle J. Jeray, MD principal investigator
Greenville Hospital System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Passive Motion in people with Intra-articular Knee Fractures, run by Prisma Health-Upstate at 1 site in United States.
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 3 inclusion and 12 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 12 Mar 2013. 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 United States. 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?
Knee Range of Motion (time frame: 48 hours, 2 weeks, 6 weeks, 3 months, 6 months and 1 year). 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 12 Mar 2013.