Early Standardized Weight Bearing Utilizing Immersion Therapy Following Periarticular Lower Extremity Fractures

NCT ID: NCT01457326

Last Updated: 2016-07-14

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 122 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2016-04-30

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.

Conditions

Lower Extremity Periarticular Fractures

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Immersion Therapy- Study

1\. Patients who participate in the immersion therapy post-operative protocol and begin progressive weight bearing at 4 weeks (study)

No interventions assigned to this group

Control Group

2\. Patients who undergo the traditional 10-week non-weight bearing post-operative care protocol (control)

No interventions assigned to this group

Eligibility Criteria

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Eric Kubiak

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erik Kubiak, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah Orthopedics

Locations

University of Utah Orthopedics Center

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

34409

Identifier Type: -

Identifier Source: org_study_id