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NCT02253966
Preoperative Intraarticular Injection of Methylprednisolone in Patients Scheduled for Total Knee-arthroplasty
Phase 2 trial testing Methylprednisoloneacetate in Knee Joint Osteoarthrosis in 48 participants. Completed in 1 March 2016.
1 March 2016
Quick facts
| Lead sponsor | Rigshospitalet, Denmark |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 48 |
| Start date | 1 October 2014 |
| Primary completion | 1 March 2016 |
| Estimated completion | 1 March 2016 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Methylprednisoloneacetate — full drug profile →
- Lidocaine
- sodium chloride (Sodium Chloride) — full drug profile →
Conditions studied
- Knee Joint Osteoarthrosis — all drugs for Knee Joint Osteoarthrosis →
- Hyperalgesia — all drugs for Hyperalgesia →
- Severe Movement Related Pain — all drugs for Severe Movement Related Pain →
Sponsor
Rigshospitalet, Denmark
Who can join
Adults 50 to 80, any sex, with Knee Joint Osteoarthrosis or Hyperalgesia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Pain
Time frame: 24 hours postoperatively
Pain intensity on a numeric rang scale (NRS) from 0 to 10 upon ambulation 24 hours following surgery
Sponsor's own description
Despite improvements in analgesic treatment following total knee arthroplasty (TKA) for osteoarthrosis, a substantial part of patients still have severe acute pain after surgery. It has been suggested that preoperative degree of intraarticular inflammation is associated to postoperative degree of pain and level of function. Furthermore it is known, that patients with preoperative inflammation have hyperalgesia and severe movement related pain. The aim of this study is to investigate the effect of a preoperative intraarticular injection of Methylprednisoloneacetate in reducing acute postoperative pain after total knee arthroplasty in patients with signs of severe pre-operative inflammation and pain.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02253966
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02253966 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Rigshospitalet, Denmark
- Last refreshed: 3 June 2016
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02253966.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing