Early Standardized Weight Bearing Utilizing Immersion Therapy Following Periarticular Lower Extremity Fractures
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 22, 2011 | ||||
| Last Updated Date | June 4, 2012 | ||||
| Start Date ICMJE | June 2009 | ||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
|
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01457326 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Short Musculoskeletal Function Assessment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Early Standardized Weight Bearing Utilizing Immersion Therapy Following Periarticular Lower Extremity Fractures | ||||
| Official Title ICMJE | Early Standardized Weight Bearing Utilizing Immersion Therapy Following Periarticular Lower Extremity Fractures: Clinical and Radiographic Outcomes | ||||
| Brief 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. 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 Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| 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. |
||||
| Condition ICMJE | Lower Extremity Periarticular Fractures | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 130 | ||||
| Estimated Completion Date | May 2013 | ||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01457326 | ||||
| Other Study ID Numbers ICMJE | 34409 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | University of Utah | ||||
| Study Sponsor ICMJE | University of Utah | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | University of Utah | ||||
| Verification Date | June 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||