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Chlorzoxazone in Hip and Knee Arthroplasty (chlorzoxazon)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02405104
Recruitment Status : Completed
First Posted : April 1, 2015
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Mogens Laursen, MD PhD, Northern Orthopaedic Division, Denmark

Brief Summary:
The purpose of this study is to elucidate whether patients operated with THA and TKA can benefit from treatment with chlorzoxazone.

Condition or disease Intervention/treatment Phase
Osteoarthritis of Hip Osteoarthritis, Knee Drug: chlorzoxazone Drug: Placebo Procedure: THA Procedure: TKA Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analgetic Effects of Chlorzoxazone in Total Hip and Knee Arthroplasty
Actual Study Start Date : September 1, 2015
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Active Comparator: THA+Klorz
All patients in this arm are treated surgically with a THA and medically with Chlorzoxazone
Drug: chlorzoxazone
ATC-code: M03BB03
Other Name: ATC-code M03BB03

Procedure: THA
Surgical treatment of osteoarthrosis in the hip, by replacement.
Other Name: Total Hip Arthroplasty

Placebo Comparator: THA+Placebo
All patients in this arm are treated surgically with a THA and medically with placebo
Drug: Placebo
Placebo

Procedure: THA
Surgical treatment of osteoarthrosis in the hip, by replacement.
Other Name: Total Hip Arthroplasty

Active Comparator: TKA+Klorz
All patients in this arm are treated surgically with a TKA and medically with Chlorzoxazone
Drug: chlorzoxazone
ATC-code: M03BB03
Other Name: ATC-code M03BB03

Procedure: TKA
Surgical treatment of osteoarthrosis in the knee, by replacement.
Other Name: Total Knee Arthroplasty

Placebo Comparator: TKA+Placebo
All patients in this arm are treated surgically with a TKA and medically with placebo
Drug: Placebo
Placebo

Procedure: TKA
Surgical treatment of osteoarthrosis in the knee, by replacement.
Other Name: Total Knee Arthroplasty




Primary Outcome Measures :
  1. Pain after 5 meter walk [ Time Frame: 24 hours post OP ]
    VAS-score


Secondary Outcome Measures :
  1. Oxford Hip/Knee score [ Time Frame: 7 days post OP ]
    standardized functional and pain score

  2. Pain at rest [ Time Frame: until 12 months after surgery ]
    VAS

  3. worst pain for the last 24 hours [ Time Frame: until 12 months after surgery ]
    VAS



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Planned primary unilateral THA or TKA
  • Patients (male/female) ≥ 18 år
  • Patients giving written informed consent and authority.
  • Patients receiving spinal anaesthesia

Exclusion Criteria:

  • Patients with intolerance to trial medications
  • Rejection of or contraindicated spinal anaesthesia
  • Patients with rheumatoid arthritis.
  • Patients with Body Mass Index (BMI) ≥ 35
  • Patients that do not read or write Danish

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02405104


Locations
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Denmark
Northern Orthopaedic Division, Clinic Farsø, Aalborg University Hospital
Farsø, Northern Jutland, Denmark
Sponsors and Collaborators
Northern Orthopaedic Division, Denmark
Investigators
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Principal Investigator: Mogens Laursen, MD, PhD Northern Orthopaedic Division, Denmark
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Responsible Party: Mogens Laursen, MD PhD, Associate Professor, PhD, Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT02405104    
Other Study ID Numbers: ON-151-MU-Klorz
First Posted: April 1, 2015    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019
Keywords provided by Mogens Laursen, MD PhD, Northern Orthopaedic Division, Denmark:
osteoarthritis
hip
knee
total hip arthroplasty
total knee arthroplasty
post operative pain management
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Chlorzoxazone
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents