NCT01343836

Brief Summary

This study is designed to compare the treatment of 2 groups in patients with Achilles tendinopathy: autologous tenocytes injection in combination with exercises versus saline injection in combination with exercises

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2011

Typical duration for phase_2

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

April 1, 2011

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 28, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

February 16, 2015

Status Verified

February 1, 2015

Enrollment Period

3.2 years

First QC Date

April 27, 2011

Last Update Submit

February 12, 2015

Conditions

TendinopathyAchilles Tendon InjuryAchillodynia

Keywords

autologous tenocytescell therapyeccentric exercises

Outcome Measures

Primary Outcomes (1)

  • VISA-A score

    a validated instrument to detect the severity of symptoms in patients with Achilles tendinopathy

    24 weeks

Secondary Outcomes (3)

  • Ultrasonographic tendon repair - Ultrasonographic Tissue Characterization (UTC)

    24 weeks

  • Subjective patient satisfaction

    24 weeks

  • Returning to sports level

    24 weeks

Study Arms (2)

Autologous Tenocyte Implantation

EXPERIMENTAL

Intratendinous ATI (autologous tenocyte implantation) injection with eccentric exercises

Other: Autologous Tenocyte Implantation

Saline injection

PLACEBO COMPARATOR

Intratendinous saline injection with eccentric exercises

Other: Saline

Interventions

Autologous Tenocyte ImplantationOTHER

Intratendinous ATI (autologous tenocyte injection) with eccentric exercises

Autologous Tenocyte Implantation
SalineOTHER

Intratendinous saline injection with eccentric exercises

Saline injection

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pain on palpation 2-7 cm proximal from the tendon insertion ("midportion")
  • Symptoms \> 2 months
  • Age 18-55 years

You may not qualify if:

  • Clinical suspicion of insertional disorders , Achilles tendon rupture, plantar flexor tenosynovitis, sural nerve pathology, peroneal subluxation
  • Condition of the Achilles tendon caused by medications such as quinolones and statins
  • Known to have the following disorders: spondylarthropathy, gout, hyperlipidemia, rheumatoid arthritis and sarcoidosis.
  • Antibiotics allergy (aminoglycoside group)
  • A condition that prevents the patients from executing an active rehabilitation programme
  • Patient has received an injection for this injury
  • Patient has received surgical intervention for this injury
  • Patient has already one site (left or right) included in this study
  • Patient does not wish, for whatever reason, to undergo one of the two treatments
  • Known pregnancy
  • Nursing women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sports medicine department Medical Center The Hague

Leidschendam, South Holland, 2262 BA, Netherlands

Location

Related Publications (1)

  • Chen J, Yu Q, Wu B, Lin Z, Pavlos NJ, Xu J, Ouyang H, Wang A, Zheng MH. Autologous tenocyte therapy for experimental Achilles tendinopathy in a rabbit model. Tissue Eng Part A. 2011 Aug;17(15-16):2037-48. doi: 10.1089/ten.TEA.2010.0492. Epub 2011 Jun 10.

    PMID: 21495863BACKGROUND

MeSH Terms

Conditions

Tendinopathy

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • J.A.N. Verhaar, Prof

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

  • P.L.J. van Veldhoven, MD

    Medical Center The Hague

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
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
Prof. J.A.N. Verhaar

Study Record Dates

First Submitted

April 27, 2011

First Posted

April 28, 2011

Study Start

April 1, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

February 16, 2015

Record last verified: 2015-02

Locations

NL(1)