Long-term Observational Study of Subjects From Tanezumab Studies Who Undergo a Total Knee, Hip or Shoulder Replacement
- Conditions
- Osteoarthritis
- Interventions
- Drug: Investigational Medical Product (IMP) administered in parent study
- Registration Number
- NCT02674386
- Lead Sponsor
- Pfizer
- Brief Summary
A4091064 is a multicenter, long-term observational study of subjects from tanezumab interventional studies (regardless of treatment group) who undergo a total knee, hip or shoulder replacement during participation in the study. The study is designed with a total duration of subject follow-up of 24 weeks after the total joint replacement surgery. There will be two methods of data collection utilized in this study: interview by site staff via the telephone and interactive web-response system (or paper if the subject has no access to the internet).
- Detailed Description
A4091064 is a long-term observational follow up study of subjects from tanezumab interventional studies A4091056, A4091057 or A4091058.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 154
- Personally signed and dated informed consent document.
- Randomized and treated with subcutaneous investigational product in a tanezumab study and has completed the study or been withdrawn from the study.
- Actual or planned total knee, hip or shoulder replacement surgery during the tanezumab study.
- Willing and able to comply with scheduled visits and other study procedures.
- None.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort 1 Investigational Medical Product (IMP) administered in parent study long-term observational study of subjects from tanezumab parent study
- Primary Outcome Measures
Name Time Method Number of Participants With Surgeon's Assessment of Procedural Difficulty Day 1 Following the TJR surgery on Day 1, the orthopedic surgeon was asked to answer the following question: "taking into consideration the participant's medical history and physical condition prior to surgery would you classify the operative procedure as Uneventful, Minor complications or Major complications." Participants were reported based on these categories for knee, hip and shoulder joint. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24 Week 24 SAPS contained four questions; How satisfied are you with the 1) results of your surgery 2) results of surgery for improving pain 3) results of surgery for improving ability to do home or yard work, and 4) results of surgery for improving your ability to do recreational activities. Items scored on a 4-point Likert scale with response of 'very satisfied' (100 points), 'somewhat satisfied' (75 points), 'somewhat dissatisfied' (50 points), and 'very dissatisfied' (25 points). The scale score calculated as mean of the scores of individual items, ranging from 25 to 100, with higher scores indicating greater satisfaction. Here, number of participants are summarized as, satisfied (very satisfied and somewhat satisfied categories combined) and dissatisfied (somewhat dissatisfied and very dissatisfied categories combined). Participants may have been counted more than once if they had TJR surgery in more than one joint.
Number of Participants With Post-Surgical Complications Upto Week 24 Baseline up to Week 24 Post-surgical complications are adverse events occurring after TJR surgery that were considered clinically significant as assessed by investigator and attributable to the total joint replacement procedure. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Number of Participants With Additional or Corrective Procedures Related to Total Joint Replacement Upto Week 24 Baseline up to Week 24 Participants were asked whether they had been told by their orthopedic surgeon that additional or corrective procedures were necessary for their total joint replacement. Participants, who responded as yes have been reported here. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Number of Participants Who Participated in Physical Rehabilitation Activities Related to Total Joint Replacement Upto Week 24 Baseline up to Week 24 Participants responded with a yes or no to the following question ''are you participating in physical rehabilitation activities related to your replaced joint''. Participants responded with a yes, have been reported here. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24 Baseline, Week 24 Participants assessed their average pain in to be replaced (pre-surgery) knee/ hip joint or in the replaced joint (post-surgery) in the past 24 hours using an 11-point numerical rating scale (NRS), ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Change from baseline was calculated using the difference between post-baseline weekly mean and the baseline mean score. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24 Baseline, Week 24 WOMAC: Self-administered, disease-specific questionnaire, which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of to be replaced/replaced index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Change from baseline was calculated using the difference between post-baseline weekly mean and the baseline mean score. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24 Baseline, Week 24 WOMAC: self-administered, disease-specific questionnaire, which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the replaced/to be replaced index joint (knee or hip) during the past 48 hours. It was calculated as the mean of scores from 2 individual questions scored on NRS. Scores for each question and WOMAC stiffness subscale score on NRS ranged from 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness. Change from baseline was calculated using the difference between post-baseline weekly mean and the baseline mean score. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24 Baseline, Week 24 WOMAC: Self-administered, disease-specific questionnaire, which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in replaced/ to be replaced index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Change From Baseline in Shoulder Pain and Disability Index (SPADI) Score at Week 24 Baseline, Week 24 SPADI: self-administered questionnaire to measure pain and disability associated with shoulder pathology in participants with shoulder pain. It consists of two dimensions pain and function. Pain dimension:5 questions regarding severity of pain, scores ranged from 0=no pain to 10=worst pain imaginable, higher scores indicated extreme pain. Functional activities:8 questions to measure degree of difficulty with various activities of daily living that require upper extremity use, scores ranged from 0=no difficulty to 10=so difficult it requires help, higher scores=extreme difficulty. Pain and disability dimension score was calculated as the sum of non-missing scores divided by the maximum possible score (50 \[for pain\] and 80 \[for disability\]) multiplied by 100. A total score was calculated as the mean of two dimensions, ranged from 0=best to 100=worst, higher scores indicated worsening of condition.
Number of Participants Who Used Concomitant Analgesic Medications Baseline up to Week 24
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (79)
George Stanley Walker, MD
🇺🇸New Orleans, Louisiana, United States
Tolna Megyei Balassa Janos Korhaz, Ortopediai Osztaly
ðŸ‡ðŸ‡ºSzekszard, Hungary
Nakajo Orthopedic Clinic
🇯🇵Sendai, Miyagi, Japan
Osaka University Hospital
🇯🇵Suita, Osaka, Japan
Medical Technologies Ltd.
🇷🇺Saint-Petersburg, Russian Federation
Stamford Therapeutics Consortium
🇺🇸Stamford, Connecticut, United States
Injury Care Research
🇺🇸Boise, Idaho, United States
CITrials
🇺🇸Santa Ana, California, United States
Physician Research Collaboration, LLC
🇺🇸Lincoln, Nebraska, United States
Marvel Clinical Research, LLC
🇺🇸Huntington Beach, California, United States
Clinical Trials Research
🇺🇸Sacramento, California, United States
JEM Research Institute
🇺🇸Atlantis, Florida, United States
Orthopedic Research Institute
🇺🇸Boynton Beach, Florida, United States
Orthopaedic Associates of West Florida
🇺🇸Clearwater, Florida, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Jacksonville, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Clintex Research Group
🇺🇸Miami, Florida, United States
American Family Medical
🇺🇸Ocala, Florida, United States
Sunshine Research Center
🇺🇸Opa-locka, Florida, United States
Gulfcoast Research Institute, LLC
🇺🇸Sarasota, Florida, United States
Kennedy White Orthopaedic Center
🇺🇸Sarasota, Florida, United States
Stedman Clinical Trials
🇺🇸Tampa, Florida, United States
Masters of Clinical Research, Inc.
🇺🇸Augusta, Georgia, United States
North Georgia Clinical Research
🇺🇸Woodstock, Georgia, United States
Chicago Clinical Research Institute, Inc.
🇺🇸Chicago, Illinois, United States
North Georgia Internal Medicine
🇺🇸Woodstock, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Best Clinical Trials, LLC
🇺🇸New Orleans, Louisiana, United States
Great Lakes Research Group, Incorporated
🇺🇸Bay City, Michigan, United States
Orthopaedic Associates of Michigan, PC
🇺🇸Grand Rapids, Michigan, United States
Optimed Research LTD
🇺🇸Columbus, Ohio, United States
Drug Trials America
🇺🇸Hartsdale, New York, United States
Remington-Davis, Incorporated
🇺🇸Columbus, Ohio, United States
AC Clinical Research
🇺🇸Tiffin, Ohio, United States
Founders Research Corporation
🇺🇸Philadelphia, Pennsylvania, United States
Abigail R. Neiman, MD, PA
🇺🇸Houston, Texas, United States
Advances In Health
🇺🇸Houston, Texas, United States
Mercury Clinical Research, Inc.
🇺🇸Houston, Texas, United States
BI Research Center
🇺🇸Houston, Texas, United States
Mercury Clinical Research
🇺🇸Webster, Texas, United States
ClinRx Research
🇺🇸Richardson, Texas, United States
Spectrum Medical, Inc.
🇺🇸Danville, Virginia, United States
Centre de recherche Saint-Louis
🇨🇦Quebec, Canada
Hospital Conde de Bertiandos
🇵🇹Ponte de Lima, Viana DO Castelo, Portugal
Central Alabama Research
🇺🇸Birmingham, Alabama, United States
Alabama Clinical Therapeutics, LLC
🇺🇸Birmingham, Alabama, United States
DCT - Stone Oak, LLC dba Discovery Clinical Trials
🇺🇸San Antonio, Texas, United States
Azienda Ospedaliero-Universitaria E Policlinico Umberto I
🇮🇹Rome, Italy
Advanced Research Center, Inc.
🇺🇸Anaheim, California, United States
Cahaba Research Inc.
🇺🇸Birmingham, Alabama, United States
Hope Clinical Research
🇺🇸Canoga Park, California, United States
Alabama Orthopaedic Surgeons
🇺🇸Birmingham, Alabama, United States
CMAX Clinical Research Pty Ltd
🇦🇺Adelaide, South Australia, Australia
Recherche Clinique Sigma inc
🇨🇦Quebec, Canada
California Research Foundation
🇺🇸San Diego, California, United States
Omuro Orthopedic Clinic
🇯🇵Himeji, Hyogo, Japan
Marunouchi Hospital
🇯🇵Matsumoto, Nagano, Japan
Saules seimos medicinos centras
🇱🇹Kaunas, Lithuania
South Pacific Clinical Trials
🇳🇿Auckland, New Zealand
Instituto de Ciencias Medicas
🇪🇸Alicante, Spain
Clinical Horizons NZ Ltd
🇳🇿Tauranga, New Zealand
Rebecca Medical Associates
🇨🇦Oakville, Ontario, Canada
Ladulaas Kliniska Studier
🇸🇪Boras, Sweden, Sweden
National Hospital Organization Osaka Minami Medical Center
🇯🇵Kawachinagano, Osaka, Japan
Institute of Rheumatology
🇷🇸Belgrade, Serbia
Kompan, s.r.o.
🇸🇰Dolny Kubin, Slovakia
Star Unit, North Shore Hospital, Waitemata District Health Board
🇳🇿Auckland, New Zealand
Rheumazentrum Prof. Dr. med Gunther Neeck
🇩🇪Bad Doberan, Germany
Southern Clinical Trials- Waitemata Ltd
🇳🇿Auckland, New Zealand
Slovak Research Center Team Member, MUDr. Viliam Cibik, PhD, s.r.o.
🇸🇰Pruske, Slovakia
ProbarE I Lund AB
🇸🇪Lund, Sweden
ProbarE i Stockholm AB
🇸🇪Stockholm, Sweden
Advances in Medicine
🇺🇸Palm Desert, California, United States
Hospital del Mar
🇪🇸Barcelona, Spain
Noble Clinical Research
🇺🇸Tucson, Arizona, United States
Professional Research Network of Kansas, LLC
🇺🇸Wichita, Kansas, United States
Baptist Health Center for Clinical Research
🇺🇸Little Rock, Arkansas, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Dawson Road Medical Centre
🇨🇦Guelph, Ontario, Canada