Lower Extremity Periarticular FracturesNCT01457326
Early Standardized Weight Bearing Utilizing Immersion Therapy Following Periarticular Lower Extremity Fractures
An observational study of Lower Extremity Periarticular Fractures, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this prospective study is evaluate the effect of a standardized early weight bearing physical therapy protocol that utilizes immersion therapy on the clinical outcomes of lower extremity periarticular fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Extremity Periarticular Fractures
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Apr 2016
- 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
- No healthy volunteers
- Adult, Older adult
Study population: This study is a prospective cohort study with a retrospective chart review. Patients who are treated by the PI, Dr. Erik Kubiak, will participate in an immersion therapy post-operative protocol. Immersion therapy post-operative protocols have been and are currently used routinely by Dr. Kubiak. Patients who are treated by Dr. Dan Horwitz and Dr. Thomas Higgins will undergo a traditional 10 week non-weight bearing post-operative care per their standard of procedure. In addition, patients of Dr. Kubiak who are unable to participate in immersion therapy for logistical reasons will be asked to participate in the traditional 10- week non-weight bearing post-operative care protocol. These patients will make up the control cohort.
Who may be able to join
- Inclusion criteria for the patient population under study consists of both male and female adults, at least 18 years old, who are treated for periarticular fractures of the lower extremity. The periarticular fractures included in this study will be: acetabular, tibial plateau, tibial plafond fractures.
Who cannot join
- Age <18 years
- Wound complications deemed to be unsafe for immersion.
- Multiple extremity articular fractures
- Other injuries that preclude their safe participation in physical therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Orthopedics Center
Salt Lake City, Utah, 84108
About this study
Official title: Early Standardized Weight Bearing Utilizing Immersion Therapy Following Periarticular Lower Extremity Fractures: Clinical and Radiographic Outcomes
The purpose of this prospective study is evaluate the effect of a standardized early weight bearing physical therapy protocol that utilizes immersion therapy on the clinical outcomes of lower extremity periarticular fractures. The investigators null hypothesis is that the early weight bearing protocol will have the same effect as a traditional 10-week non-weight bearing protocol on clinical outcomes.
Read the detailed description
Fractures of the lower extremity are common injuries that can lead to temporary or permanent disability.13 Fracture healing, regardless of treatment, is a multifactorial process that is influenced by time, biomechanics, and host biology (among other variables). The degree, timing, progression, and type of weight bearing after fractures involving the pelvis and lower extremities is an area of debate in the clinical management of a broad spectrum of orthopedic injuries.1,2,4-9,11,15 Periarticular fractures of weight bearing joints are an area of particular interest with regard to post-operative weight bearing due to the prolonged periods that patients must be non-weight bearing after surgery.
Some degree of impairment is inevitable with any traumatic injury. The majority of authors writing about post-fracture weight bearing have determined that timing and extent of weight bearing has an effect on fracture healing, while a small number of authors have published results demonstrating the opposite.14,16,19,21 In addition to potential impacts on healing rates, limited or non-weight bearing carries the added insult of loss of bone density and muscle mass.3,10,12,17,20,22
Traditionally, patients with periarticular fractures have been required to be non-weight bearing on their effected extremity for up to 12 weeks. At this institution, most patients have been required to remain non-weight bearing for 10 weeks, followed by progressively increased levels of weight bearing according to patient tolerance. One of the orthopaedic traumatologists at this institution uses immersion therapy to allow patients with periarticular fractures to begin weight bearing prior to the ten-week mark.
Immersion therapy requires that patients perform their physical therapy, with a trained therapist, in a swimming pool. The use of the pool in post-fracture care may be able to provide a structured and standardized partial weight-bearing environment that could allow for early mobilization. It also has the potential to improve clinical outcomes by mitigating at least some of the loss in bone and muscle mass during the post-operative period; thereby, potentially speeding functional recovery. Immersion therapy is currently utilized on-site at the University of Utah Orthopedic Center for a variety of diagnoses, including in post-fracture care.
There is essentially no orthopedic literature regarding immersion therapy in the management of post-fracture rehabilitation with regard to early weight bearing. Specifically, the investigators are aware of no clinical outcome studies that investigate standardized early weight bearing protocols following periarticular fractures of the lower extremity.
- Conditions
- Lower Extremity Periarticular Fractures
- Keywords
- Immersion therapy, early weight bearing physical therapy
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 |
|---|---|---|
| Immersion Therapy- Study | 1. Patients who participate in the immersion therapy post-operative protocol and begin progressive weight bearing at 4 weeks (study) | |
| Control Group | 2. Patients who undergo the traditional 10-week non-weight bearing post-operative care protocol (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immersion Therapy
- Standard ROM while in the hospital
- two weeks of immersion therapy, patients perform their physical therapy immersed in the pool to their neck (5-10% total body weight).
- weeks 6-8, patients are immersed to their mid-chest (nipple level- 15-30% total body weight).
- weeks 8-10, patients are progressed to physical therapy while immersed only to their waist (navel level- 50-60% total body weight).
- ten weeks, patients are allowed to weight bear as tolerated and begin formal dry land ambulation training under the supervision of a licensed physical therapist .
Measured: 10 weeks
Traditional non-weightbearing
- ROM therapy initiated in the hospital.
- Passive Motion therapy for 4 weeks.
- Formal physical therapy continued as needed
Measured: 10 weeks
Secondary outcomes (1)
Short Musculoskeletal Function Assessment
- Time to return to work. Assessed at each clinical visit, and by mailings if necessary.
- Standard radiographs will be obtained from the study patients per usual at post-operative visits. Any loss of fixation will be assessed. No additional radiographs will be obtained outside of the current standard of care.
- Adverse events will be tabulated.
- The short Musculoskeletal Function Assessment (SMFA) will be administered at patient's 3 month, 6 month and 1 year follow-up clinic appointments and/or by mail, as necessary.
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 posted21 Oct 2011 (estimated)
- Study startJun 2009
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: Loss to follow-up rate too high for publication and data on completed patients does not allow for a powered analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity Periarticular FracturesStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Kubiak, University of Utah
- Investigators
- Erik Kubiak, MD, Principal investigator, University of Utah Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457326
- Sponsor's protocol ID
- 34409
- Status last verified
- Jun 2016
- First submitted
- 22 Aug 2011
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Standardized Weight Bearing Utilizing Immersion Therapy Following Periarticular Lower Extremity Fractures: Clinical and Radiographic Outcomes
- ClinicalTrials.gov ID
- NCT01457326
- Acronym / sponsor ID
- 34409
- Conditions
- Lower Extremity Periarticular Fractures
- Keywords
- Immersion therapy, early weight bearing physical therapy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Loss to follow-up rate too high for publication and data on completed patients does not allow for a powered analysis.
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 21 Oct 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.
The purpose of this prospective study is evaluate the effect of a standardized early weight bearing physical therapy protocol that utilizes immersion therapy on the clinical outcomes of lower extremity periarticular fractures. The investigators null hypothesis is that the early weight bearing protocol will have the same effect as a traditional 10-week non-weight bearing protocol on clinical outcomes.
Detailed description
Fractures of the lower extremity are common injuries that can lead to temporary or permanent disability.13 Fracture healing, regardless of treatment, is a multifactorial process that is influenced by time, biomechanics, and host biology (among other variables). The degree, timing, progression, and type of weight bearing after fractures involving the pelvis and lower extremities is an area of debate in the clinical management of a broad spectrum of orthopedic injuries.1,2,4-9,11,15 Periarticular fractures of weight bearing joints are an area of particular interest with regard to post-operative weight bearing due to the prolonged periods that patients must be non-weight bearing after surgery.
Some degree of impairment is inevitable with any traumatic injury. The majority of authors writing about post-fracture weight bearing have determined that timing and extent of weight bearing has an effect on fracture healing, while a small number of authors have published results demonstrating the opposite.14,16,19,21 In addition to potential impacts on healing rates, limited or non-weight bearing carries the added insult of loss of bone density and muscle mass.3,10,12,17,20,22
Traditionally, patients with periarticular fractures have been required to be non-weight bearing on their effected extremity for up to 12 weeks. At this institution, most patients have been required to remain non-weight bearing for 10 weeks, followed by progressively increased levels of weight bearing according to patient tolerance. One of the orthopaedic traumatologists at this institution uses immersion therapy to allow patients with periarticular fractures to begin weight bearing prior to the ten-week mark.
Immersion therapy requires that patients perform their physical therapy, with a trained therapist, in a swimming pool. The use of the pool in post-fracture care may be able to provide a structured and standardized partial weight-bearing environment that could allow for early mobilization. It also has the potential to improve clinical outcomes by mitigating at least some of the loss in bone and muscle mass during the post-operative period; thereby, potentially speeding functional recovery. Immersion therapy is currently utilized on-site at the University of Utah Orthopedic Center for a variety of diagnoses, including in post-fracture care.
There is essentially no orthopedic literature regarding immersion therapy in the management of post-fracture rehabilitation with regard to early weight bearing. Specifically, the investigators are aware of no clinical outcome studies that investigate standardized early weight bearing protocols following periarticular fractures of the lower extremity.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immersion Therapy- Study | – | –1. Patients who participate in the immersion therapy post-operative protocol and begin progressive weight bearing at 4 weeks (study) |
| Control Group | – | –2. Patients who undergo the traditional 10-week non-weight bearing post-operative care protocol (control) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is a prospective cohort study with a retrospective chart review. Patients who are treated by the PI, Dr. Erik Kubiak, will participate in an immersion therapy post-operative protocol. Immersion therapy post-operative protocols have been and are currently used routinely by Dr. Kubiak. Patients who are treated by Dr. Dan Horwitz and Dr. Thomas Higgins will undergo a traditional 10 week non-weight bearing post-operative care per their standard of procedure. In addition, patients of Dr. Kubiak who are unable to participate in immersion therapy for logistical reasons will be asked to participate in the traditional 10- week non-weight bearing post-operative care protocol. These patients will make up the control cohort.
Key inclusion criteria (1 listed)
- Inclusion criteria for the patient population under study consists of both male and female adults, at least 18 years old, who are treated for periarticular fractures of the lower extremity. The periarticular fractures included in this study will be: acetabular, tibial plateau, tibial plafond fractures.
Key exclusion criteria (4 listed)
- Age <18 years
- Wound complications deemed to be unsafe for immersion.
- Multiple extremity articular fractures
- Other injuries that preclude their safe participation in physical therapy.
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
Immersion Therapy
Time frame: 10 weeks
1. Standard ROM while in the hospital 2. two weeks of immersion therapy, patients perform their physical therapy immersed in the pool to their neck (5-10% total body weight). 3. weeks 6-8, patients are immersed to their mid-chest (nipple level- 15-30% total body weight). 4. weeks 8-10, patients are progressed to physical therapy while immersed only to their waist (navel level- 50-60% total body weight). 5. ten weeks, patients are allowed to weight bear as tolerated and begin formal dry land ambulation training under the supervision of a licensed physical therapist .
Traditional non-weightbearing
Time frame: 10 weeks
1. ROM therapy initiated in the hospital. 2. Passive Motion therapy for 4 weeks. 3. Formal physical therapy continued as needed
1 secondary outcome
Short Musculoskeletal Function Assessment
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Loss to follow-up rate too high for publication and data on completed patients does not allow for a powered analysis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2016.
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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.
Erik Kubiak, MD principal investigator
University of Utah Orthopedics
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 Lower Extremity Periarticular Fractures, run by University of Utah 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 1 inclusion and 4 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 14 Jul 2016. 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 was stopped early (reason given: Loss to follow-up rate too high for publication and data on completed patients does not allow for a powered analysis.). 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?
Immersion Therapy (time frame: 10 weeks). The study lists 2 primary outcomes in all. 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 14 Jul 2016.