ClinicalTrials.gg
CompletedNCT01405664Updated Aug 21, 2024

the Effect of Weight Bearing Status on Healing and Pain Outcomes After Surgery for Osteochondral Defects of the Ankle

An interventional study of Weight-Bearing as Tolerated in Osteochondritis Dissecans of Ankle and Joints of Foot, sponsored by Nova Scotia Health Authority. Completed at 1 site in Canada. Open to participants aged 16 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-21.

Sponsored by Nova Scotia Health Authority · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
16 Years to 65 Years
Sex
All
01

Study summary

The rationale for this research study is to evaluate the effect on clinical outcomes of weight bearing as tolerated after forage surgery for the treatment of osteochondral defects of the ankle, thus potentially eliminating the need for a period of immobilisation or non-weight bearing after surgery.

The investigators hypothesize that their will be no difference in functional outcomes between weight bearing as tolerated as compared to non-weight bearing for six weeks after forage surgery for OCD of the ankle.

Read the detailed description

The hypothesis for advantage of the investigational post-operative therapy is based on:

Equivalent clinical outcomes to non-weight bearing; Similar radiographic findings on CT at follow-up visit between the two groups; reduced morbidity and disability to subjects through elimination of a period of non-weight bearing; reduction of cost to patients by eliminating need for adjuvant walking and mobility aids (crutches, taxis) and time off work.

02

Conditions studied

  • Osteochondritis Dissecans of Ankle and Joints of Foot
03

In context

Osteochondritis Dissecans

30 studies on the registry are indexed under Osteochondritis Dissecans; 7 are open to participants now.

This study's enrollment of 68 is above the median of 45 across 17 interventional studies indexed under Osteochondritis Dissecans.

Browse Osteochondritis Dissecans studies →

Lead sponsor

Nova Scotia Health Authority is the lead sponsor of 264 studies on the registry; 78 are open to participants now.

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

04

Who can participate

Ages eligible
16 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

  • Patients aged 16-60 years
  • No prior ankle surgery
  • Able and willing to comply with follow-up
  • Capable of provide
  • Medically fit for surgery
  • Lesions on preoperative CT Scan \< 1.5cm
  • Symptomatic (ie:pain, restricted activities, inability to WB, decreased ROM)
  • Single Isolated lesion
  • Failure of conservative treatment (3 months of limited activities and/or weight bearing and/or immobilization)

Exclusion criteria

Exclusion Criteria:

Age less than 16 years or greater than 60 years

  • Inflammatory arthritis
  • Diffuse osteoarthritis of affected joint
  • Associated fracture
  • Prior ankle surgery for current injury (including arthroscopy)
  • Unable to comply with follow-up
  • Unable to provide
  • Bernt \& Hardy class IV (amenable to ORIF)
  • Multiple osteochondral defects in one ankle or touching osteochondral lesions of tibia and talus
  • Prior osteochondral defects of the affected ankle
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

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

Study arms

  • No intervention
    Non-Weight Bearing x 6 weeks
  • Experimental
    Immediate Weight-Bearing as Tolerated

    Other: Weight-Bearing as Tolerated

Interventions

  • OtherWeight-Bearing as Tolerated

    WBAT immediately after surgery

    Also known as: Weight-bearing status

06

What researchers measure

Primary outcomes

  1. Ankle Osteoarthritis Scale

    Pain and disability outcomes assessed on scale of 1-100. The higher the score is more pain\\disability

    Time frame: 12 months

Secondary outcomes

  1. CAT Scan

    For assessment of cartilage healing

    Time frame: 12months

07

Study locations

1 site
  • Queen Elizabeth II Health Sciences Centre, Halifax Infirmary
    Halifax, Nova Scotia B3H3A7, Canada
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2011 to primary completion in Sep 2022, 132 months.

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

Registered
Jul 27, 2011
First posted
Jul 29, 2011
StartActual
Sep 1, 2011
Primary completionActual
Sep 30, 2022
CompletionActual
Sep 30, 2023
Last update
Aug 21, 2024
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 Aug 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01405664
Responsible party
Sponsor
First posted
Jul 29, 2011
Start date
Sep 1, 2011
Primary completion
Sep 30, 2022
Completion
Sep 30, 2023
Last update
Aug 21, 2024

Study contacts

Mark Glazebrook, MD,FRCSC
principal investigator · Nova Scotia Health Authority

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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