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TerminatedNCT00816647Updated Jun 14, 2011

A Prospective Randomized Study of Medial Patellofemoral Ligament (MPFL) Reconstruction

An interventional study of Patellofemoral stabilizing surgery in Patella-Dislocation, Patellofemoral Osteoarthritis and Patellar Instability, sponsored by Finnish Defense Forces. Terminated at 1 site in Finland. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2011-06-14.

Sponsored by Finnish Defense Forces · Not applicable, Interventional, and Treatment

Why this study was terminated
Stopped for benefit of the MPFL reconstruction arm and due to safety concerns of the medial reefing arm.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study summary

The operative management of chronic patellar instability has been controversial. Medial patellofemoral ligament reconstruction has gained success recently and might be superior to other soft-tissue procedures. The objective of this prospective study was to compare the clinical outcome after medial patellofemoral ligament reconstruction compared with medial reefing for chronic patellar instability.

Read the detailed description

Many of the previous studies on medial patellofemoral ligament (MPFL) reconstruction for patellar instability have been difficult to interpret, either because the study setting has included both first-time and recurrent dislocations, or because a lack of control group. Moreover, several studies have enrolled patients with a wide age range, and the majority of the studies have employed retrospective and nonrandomized study designs. Therefore the investigators designed a prospective, randomized study with the primary goal to compare the outcome after MPFL reconstruction with medial reefing for chronic patellar instability. The distance between tibial tubercle and trochlear groove is measured on MRI and corrected if it exceeds 17mm. Primary outcome measure is the occurrence of recurrent objective and subjective patellar instability. The second goal is to evaluate the development of articular cartilage lesions within the patellofemoral joint, and assess clinical scores.

02

Conditions studied

  • Patella-Dislocation
  • Patellofemoral Osteoarthritis
  • Patellar Instability

Keywords

  • Patella
  • Dislocation
  • Knee
  • Medial Patellofemoral Ligament
03

In context

Patellar Dislocation

41 studies on the registry are indexed under Patellar Dislocation; 9 are open to participants now.

This study's planned enrollment of 50 is close to the median of 50 across 22 interventional studies indexed under Patellar Dislocation.

Browse Patellar Dislocation studies →

Lead sponsor

Finnish Defense Forces is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Chronic patellar instability (more than 2 dislocations)
  • Minimum 6 months nonoperative treatment

Exclusion criteria

Exclusion Criteria:

  • Severe PF OA
  • Acute patellar dislocation
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    1

    Medial patellofemoral ligament reconstruction

    Procedure: Patellofemoral stabilizing surgery

  • Active comparator
    2

    Medial reefing

    Procedure: Patellofemoral stabilizing surgery

Interventions

  • ProcedurePatellofemoral stabilizing surgery

    Comparison of surgical techniques

06

What researchers measure

Primary outcomes

  1. Recurrent patellar instability

    Time frame: 2 years

Secondary outcomes

  1. Patellofemoral osteoarthrosis progression.

    Time frame: 2 years

07

Study locations

1 site
  • Tampere University Hospital
    Tampere, 33521, Finland
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2008, a primary completion of Jun 2011 and a completion of Jun 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 31, 2008
First posted
Jan 1, 2009
Start
Dec 2008
Primary completionEst.
Jun 2011
CompletionEst.
Jun 2011
Last update
Jun 14, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 14, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00816647
Lead sponsor
Finnish Defense Forces
First posted
Jan 1, 2009
Start date
Dec 2008
Primary completion
Jun 2011 (estimated)
Completion
Jun 2011 (estimated)
Last update
Jun 14, 2011

Study contacts

Petri J Sillanpaa, M.D., PhD
principal investigator · Tampere University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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