Clinical Trials
The broad patient
base, dedicated research staff, and computer infrastructure support
excellence in clinical research in the Department of Orthopedics and
Physical Rehabilitation.
Patient Registries: creating longitudinal databases of patient outcomes
The Department of Orthopedics has developed two
unique, web-based, registries that integrate clinical,
patient-reported, and long-term functional outcomes for total joint
replacement and spine patients. At regular intervals, patients
complete computer pain and function assessments (SF-36, Western Ontario
Musculoskeletal Assessment, Oswestry Spine survey) when they visit
their surgeon. The data are scored and printed to support
patient-physician treatment decisions. The information is stored along
with patient demographic data, nurse histories, and physical
examination data. Finally, inpatient information from the hospital
information system is merged. In addition, Hand and Upper Extremity
Center patients are now uniformly documenting function and a registry
is being developed.
The registry data serve retrospective and
prospective research, quality and outcome assessment for UMass Memorial
Healthcare, and support clinicians in patient care.
Other Orthopedic Clinical Trials
A
wide array of investigator-initiated and multi-center
industry-sponsored clinical trials are ongoing in the Department of
Orthopedics and Physical Rehabilitation. The large volume and diversity
of patients from across central, western, and southern Massachusetts
makes the Orthopedic Clinical Centers ideal places to recruit, enroll,
and conduct clinical research. Experienced research assistants,
including nurses, staff each study and assure regulatory compliance and
successful completion of studies. In addition to faculty, residents and
fellows participate in these efforts.
Areas of recent studies include:
Arthritis and Total Joint Replacement Center; Memorial Campus
Comparative trials of alternative prosthetic designs and evaluation of surgical and long-term functional outcomes.
Phase I, ll and lll trials for novel treatment of osteoarthritis Spine Center ; Memorial Campus
Retrospective
evaluation of outcomes associated with bone grafting in chronic
degenerative lumbar disease and traumatic cervical injuries. Hand Clinic; Hahnemann Campus
Prospective evaluation of predictors of optimal functional outcome in carpal tunnel surgery. Sports Center; Hahnemann Campus
- Prospective
evaluation of intra-operative administration of hyaluronic acid for
relief of symptoms in knee/shoulder osteoarthritis.
- Phase III Clinical trial on operative knee procedures and technique
Trauma Center
Longitudinal evaluation of morbidity and mortality in ankle fractures among the elderly.
Outcomes Research
Outcomes
research seeks to understand the end results of particular health care
practices and interventions. End results include effects that people
experience and care about, such as change in the ability to function.
In
particular, for individuals with chronic conditions—where cure is not
always possible—end results include quality of life as well as
mortality. By linking the care people get to the outcomes they
experience, outcomes research has become the key to developing better
ways to monitor and improve the quality of care.”
http://www.ahrq.gov/clinic/outfact.htm
Link to Patricia Franklin research page
UMMS Department of Orthopedics and Physical Rehabilitation has a wide array of ongoing outcomes research.
Background: Osteoarthritis is growing and arthroplasty effectively relieves pain.
Arthritis
is the leading cause of disability among U.S. adults and a significant
public health challenge. By 2020, it is estimated that 60 million Americans will be affected by arthritis.
Twenty seven percent of Caucasians, 32% of African Americans and 36% of
poor U.S. adults report limited activity due to their arthritis.
Currently, half of adults over 65 years and 60% of women of all ages
have arthritis making it the leading chronic condition among women. Of
these, more than 90% have osteoarthritis (OA), a degenerative condition
of joint cartilage with no known cure. However, OA’s symptoms can be
treated. Exercise, activity, self-care, and medication can effectively
relieve knee OA pain and improve function. Yet less than one percent
of arthritic adults receive self-care instruction. (CDC 2004) Finally,
when OA pain and disability persists despite comprehensive medical
care, arthroplasty is a highly effective option.
The case of TKR:
In the past decade, TKR utilization has increased 73% so that in 2003
more than 427,000 procedures were performed costing $13.5 billion.
Two-thirds of TKR patients are older than 65 years making TKR
Medicare’s most costly procedure. Furthermore, Healthy People 2010
proposes to increase TKR utilization while eliminating racial and
ethnic disparity in use. However, following technically successful TKR
surgery, 12-25% of patients report minimal 12 month functional
improvement while another 10% report functional gains as high as 3
times the national average. In order to assure uniform functional gains
after successful TKR surgery, we are studying demographic, behavioral,
and clinical predictors of self-care and activity.
Research includes:
• Developing objective measures of peri-TKR exercise and activity
Variation
in patients' independent exercise and activity after TKR surgery may
contribute to variable functional outcomes. We are evaluating the use
of daily exercise logs and step activity monitors (accelerometers) to
quantify exercise and home activity after TKR. Pilot data identified
significant variation in quantity of daily exercises after surgery. In
addition, exercise varied with patient attributes. Women with poor
emotional health recorded fewer repetitions and greater variation. More
daily exercise repetitions correlated with larger 6-month functional
improvement. J Arthroplasty. 2006 Sep;21(6 Suppl 2):157-63. • Peri-operative behavioral intervention for patients with poor emotional health to improve functional outcomes
The
one-third of TKR patients with poor pre-TKR emotional health have
significantly poorer 6 and 12-month post-TKR physical function when
compared with patients with higher emotional health scores. (Heck,
1998; Ayers, 2004) The proposed telephone-support program will address
anxiety and depression, enhance psychological coping, and improve
adherence to prescribed post-TKR exercise and physical activity. Clin
Orthop Relat Res. 2005 Nov;440:157-61.
• Objective prediction models to guide patient and physician decisions for TKR
To
date, no one patient attribute or surgical factor offers a satisfactory
explanation for this variation. Using a unique national database of
over 8000 TKR patients, we are developing individual patient prediction
models to match pre-TKR patient attributes with likely post-TKR
functional improvement. We will translate these models to an
interactive, web-based program to support patient and referring
clinician decisions.
• Integrating computer-assisted, patient-reported pain and function into ambulatory care to support shared decision making
Patients
in the Arthritis and Total Joint Center and Spine Center complete
web-based, standardized pain and function assessments at each office
visit to (1) trend symptoms in the ambulatory record, (2) guide
patient-physician discussions of treatment options and (3) document
patient outcomes. These data are stored in a unique registry of
clinical and patient information for future research.
• Evidence-based knowledge from a patient web-site being developed through National Library of Medicine Outreach funds
Patients
will be introduced to the education web-site while at the Arthritis and
TJR Center. The site will include expert, trusted information that can
be accessed from home, community centers, or primary care physician
offices. NLM resources will include the patient tutorials on
osteoarthritis, TJR, and post-surgery rehabilitation and materials will
be available in English and Spanish.