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NCT03082092

Pre-operative Intravenous Steroid in Total Knee Replacement for Pain Relief and Recovery

Completed Phase 4 Last updated 4 September 2019
What this trial tests

Phase 4 trial testing Methylprednisolone Sodium Succinate in Osteoarthritis, Knee in 60 participants. Completed in 1 June 2019.

Timeline
1 June 2017
Primary endpoint
1 June 2019
1 June 2019

Quick facts

Lead sponsorQueen Elizabeth Hospital, Hong Kong
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment60
Start date1 June 2017
Primary completion1 June 2019
Estimated completion1 June 2019
Sites1 location across Hong Kong

Drugs / interventions tested

Conditions studied

Sponsor

Queen Elizabeth Hospital, Hong Kong

Who can join

Adults 18 to 85, any sex, with Osteoarthritis, Knee. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Osteoarthritis of the knee is a common and important condition in our society. Despite various anesthetic methods and pain medications, pain after operation still remains as a challenge. Steroids plays a role in decreasing the inflammatory reaction and stress response from surgery. This study is to evaluate the use of an additional steroid injection, on top of usual pain killers and anesthesia, on the effect of pain control and recovery after total knee replacement. 50 subjects will be recruited, half of them will be randomized to receive a single dose of steroid injection before operation while the other half will receive a placebo. All the doctors, patients and physiotherapists are not aware of the allocation. Apart from the steroid or placebo injection, all the other treatment (eg: surgery, medications, rehabilitation protocol etc) will be the same. Doctors and physiotherapists will assess the subjects at 24, 30, 48 hours after surgery and upon discharge for their pain relief and recovery. Any complications will also be documented.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Pre-operative intravenous steroid improves pain and joint mobility after total knee arthroplasty in Chinese population: a double-blind randomized controlled trial.
    Cheng BLY, So EHK, Hui GKM, Yung BPK, et al · · 2019 · cited 14× · PMID 31222540 · DOI 10.1007/s00590-019-02469-5
  2. Pharmaceutical therapeutics for articular regeneration and restoration: state-of-the-art technology for screening small molecular drugs.
    Chen Y, Sun H, Yao X, Yu Y, et al · · 2021 · cited 9× · PMID 34783870 · DOI 10.1007/s00018-021-03983-8

Verify or expand the search:

Other trials of Methylprednisolone Sodium Succinate

Trials testing the same drug.

Other recruiting trials for Osteoarthritis, Knee

Currently open trials in the same condition.

Other Queen Elizabeth Hospital, Hong Kong trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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