CompletedPhase 3

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

United States154 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 range18 Years

SexALL

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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and treated with subcutaneous investigational product in a tanezumab study and has completed the study or been withdrawn from the study.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.

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

Timeframe: Baseline, 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 range18 Years

SexALL

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

Timeframe: Baseline, Week 24