NCT02039804

Brief Summary

Trochanteric pain can be caused by osteoarthritis of the hip, fracture, tendinitis, nerve pathology and trochanteric bursitis. Trochanteric bursitis is often seen at the outpatient clinic and is characterized by chronic lateral hip pain in the vicinity of the trochanter major, overlying the lateral aspect of the hip. When pain is persistent after conventional therapies, anesthetic and corticosteroid (CS) injections can provide short term to intermediate relief of pain, but relapse is common. Only one retrospective study showed the efficacy of intra-bursal trochanteric injections with HA and CS. They concluded that the pain release is significant with large effect sizes for both treatment. However, the efficacy of CS appeared to be short lived and it was shown that the efficacy of HA at 6 and 12 months is significant compared to CS (p\<0.05). In this study we want to compare the efficacy of corticosteroids and hyaluronic acid in the treatment of trochanteric bursitis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2013

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 26, 2014

Status Verified

March 1, 2014

Enrollment Period

9 months

First QC Date

July 24, 2013

Last Update Submit

March 25, 2014

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • VAS for pain

    26 weeks after administration

Secondary Outcomes (2)

  • Harris Hip Score

    6, 12, 26 weeks

  • VAS for pain

    6 and 12 weeks after administration

Other Outcomes (1)

  • Patient's Global Assessment of Normal Function/Activity

    6, 12, 26 weeks

Study Arms (2)

Hyaluronic acid

EXPERIMENTAL

Injectable hyaluronic acid.

Device: Hyaluronic acid

Corticosteroids

ACTIVE COMPARATOR

Injectable corticosteroids.

Drug: Corticosteroids

Interventions

CorticosteroidsDRUG

Intra-bursal injection

Also known as: Depo-Medrol 40mg
Corticosteroids
Hyaluronic acidDEVICE

Intra-bursal injection

Also known as: SportVis
Hyaluronic acid

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, 18 years and older, but \<75 years;
  • VAS for pain \> 30mm;
  • Diagnosis of trochanteric bursitis as suggested by Brinks et al with symptoms for more than 3 months (3);
  • Failure of conservative therapy of more than one month;
  • Written informed consent;
  • Available for the duration of the investigation.

You may not qualify if:

  • Previous surgery in the same region;
  • Current other problem(s) in the affected extremity;
  • Diabetes mellitus;
  • Patient who received a local (CS) injection within 3 months from the baseline visit;
  • Allergic or hypersensitive to CS or HA;
  • Patients suffering (chronic) low back pain with or without sciatic pain;
  • Patients with radiographic signs of moderate or severe hip osteoarthritis (Kellgren and Lawrence \>1);
  • Pregnant or lactating, or woman of childbearing potential not willing to use an acceptable method of contraception during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, 3212, Belgium

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Adrenal Cortex HormonesMethylprednisolone Acetate

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone AntagonistsMethylprednisolonePrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Sascha Colen, MD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sascha Colen, MD

CONTACT

0032-497180798sascolen@hotmail.com

Study Design

Study Type
interventional
Phase
phase 3
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
MD

Study Record Dates

First Submitted

July 24, 2013

First Posted

January 20, 2014

Study Start

March 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2015

Last Updated

March 26, 2014

Record last verified: 2014-03

Locations

BE(1)