NCT00757289

Brief Summary

The study is to compare the efficacy of autologous platelet concentrate injections to corticosteroid injection in patients suffering from tennis elbow with respect to pain and function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Aug 2007

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 23, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

May 19, 2017

Status Verified

May 1, 2017

Enrollment Period

5 months

First QC Date

September 22, 2008

Last Update Submit

May 17, 2017

Conditions

Pain

Keywords

Tennis Elbow

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Score - Pain

    4months,12 months,24months & 52 months

Secondary Outcomes (2)

  • DASH

    4months,12months,24months & 52 months

  • Complications

    Anytime

Study Arms (2)

1

EXPERIMENTAL

PRP injection

Biological: PRP Injection

2

ACTIVE COMPARATOR

Corticosteroid Injection

Biological: Corticosteroid Injection

Interventions

PRP InjectionBIOLOGICAL

PRP Injection

1
Corticosteroid InjectionBIOLOGICAL

Corticosteroid Injection

2

Eligibility Criteria

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

You may qualify if:

  • Patient with chronic epicondylitis lateralis who do not react to conservative treatment and therefore are send to the orthopedic surgeon

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elisabeth ziekenhuis

Tilburg, Netherlands

Location

MeSH Terms

Conditions

PainTennis Elbow

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsElbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Taco Gosens, MD

    Elisabeth ziekenhuis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2008

First Posted

September 23, 2008

Study Start

August 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2009

Last Updated

May 19, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)