Chlorzoxazone in Hip and Knee Arthroplasty

NCT02405104 | Completed Phase 4 DMC

• 1 other identifier: ON-151-MU-Klorz
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoarthritis of Hip; Osteoarthritis, Knee

Keywords

osteoarthritis; hip; knee; total hip arthroplasty; total knee arthroplasty; post operative pain management

Outcome Measures

Primary Outcomes (1)

• Pain after 5 meter walk

  VAS-score

  24 hours post OP

Secondary Outcomes (3)

• Oxford Hip/Knee score

  7 days post OP

• Pain at rest

  until 12 months after surgery

• worst pain for the last 24 hours

  until 12 months after surgery

Study Arms (4)

THA+Klorz

ACTIVE COMPARATOR

All patients in this arm are treated surgically with a THA and medically with Chlorzoxazone

Drug: chlorzoxazone; Procedure: THA

THA+Placebo

PLACEBO COMPARATOR

All patients in this arm are treated surgically with a THA and medically with placebo

Drug: Placebo; Procedure: THA

TKA+Klorz

ACTIVE COMPARATOR

All patients in this arm are treated surgically with a TKA and medically with Chlorzoxazone

Drug: chlorzoxazone; Procedure: TKA

TKA+Placebo

PLACEBO COMPARATOR

All patients in this arm are treated surgically with a TKA and medically with placebo

Drug: Placebo; Procedure: TKA

Interventions

chlorzoxazone DRUG

ATC-code: M03BB03

Also known as: ATC-code M03BB03

THA+Klorz; TKA+Klorz

Placebo DRUG

Placebo

THA+Placebo; TKA+Placebo

THA PROCEDURE

Surgical treatment of osteoarthrosis in the hip, by replacement.

Also known as: Total Hip Arthroplasty

THA+Klorz; THA+Placebo

TKA PROCEDURE

Surgical treatment of osteoarthrosis in the knee, by replacement.

Also known as: Total Knee Arthroplasty

TKA+Klorz; TKA+Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northern Orthopaedic Division, Denmark: lead

Study Sites (1)

Northern Orthopaedic Division, Clinic Farsø, Aalborg University Hospital

Farsø, Northern Jutland, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis, Knee; Osteoarthritis

Interventions

Chlorzoxazone; Tacrine; Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Benzoxazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Aminoacridines; Acridines; Heterocyclic Compounds, 3-Ring; Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Mogens Laursen, MD, PhD

  Northern Orthopaedic Division, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, PhD

Study Record Dates

• First Submitted: March 27, 2015
• First Posted: April 1, 2015
• Study Start: September 1, 2015
• Primary Completion: December 31, 2017
• Study Completion: July 31, 2019
• Last Updated: September 9, 2019

Record last verified: 2019-09

Locations

DK (1)