CompletedPhase 3

Long-term Observational Study of Subjects From Tanezumab Studies Who Undergo a Total Knee, Hip or Shoulder Replacement

United States, Australia, Canada154 participantsStarted 2016-08-23

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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and treated with subcutaneous investigational product in a tanezumab study and has completed the study or been withdrawn from the study.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. Exclusion Criteria: \- None.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Surgeon's Assessment of Procedural Difficulty

Timeframe: Day 1

Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24

Timeframe: Week 24

Number of Participants With Post-Surgical Complications Upto Week 24

Timeframe: Baseline up to Week 24

Number of Participants With Additional or Corrective Procedures Related to Total Joint Replacement Upto Week 24

Timeframe: Baseline up to Week 24

Number of Participants Who Participated in Physical Rehabilitation Activities Related to Total Joint Replacement Upto Week 24

Timeframe: Baseline up to Week 24

Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24

Timeframe: Baseline, Week 24

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24

Trial details

NCT IDNCT02674386

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-07-15

Results submitted2020-07-06

View on ClinicalTrials.gov More Osteoarthritis trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With Surgeon's Assessment of Procedural Difficulty

Timeframe: Day 1

Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24

Timeframe: Week 24

Number of Participants With Post-Surgical Complications Upto Week 24

Timeframe: Baseline up to Week 24

Number of Participants With Additional or Corrective Procedures Related to Total Joint Replacement Upto Week 24

Timeframe: Baseline up to Week 24

Number of Participants Who Participated in Physical Rehabilitation Activities Related to Total Joint Replacement Upto Week 24

Timeframe: Baseline up to Week 24

Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24

Timeframe: Baseline, Week 24

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24