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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02190188
Other study ID # 602010072014
Secondary ID 602011072014
Status Completed
Phase N/A
First received July 12, 2014
Last updated March 21, 2018
Start date March 2014
Est. completion date January 1, 2018

Study information

Verified date March 2018
Source Medical University Innsbruck
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Research on the implications of orthotic devices and the recovery after knee arthroscopy are widely known. But only a handful of specific issues have been studied to date. However, the effect of orthotic devices on the recovery after partial meniscectomy are largely unknown. To our best knowledge, there are no studies that deal with the treatment of partial medial or lateral meniscectomy with wedge insoles, valgus or varus knee braces. The purpose of this study is to find out if using wedge inserts or knee orthoses improve the outcomes after partial meniscectomy.

We therefore verify the following hypothesis: In patients with partial meniscectomy can be by the postoperative use of exculpatory wedge deposits or relieving knee brace achieve a significantly better clinical outcome than without specific treatment.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date January 1, 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- full leg x-ray to measure the leg axis

- undersigned Informed Consent Form

Exclusion Criteria:

- at the same time conducted or within one year subsequent corrective osteotomies of the leg axis

- medial meniscectomy combination and valgus

- combination of lateral meniscectomy and varus

- psychiatric or neurological comorbidities that produce a poor compliance

- forth degree cartilage lesions or evident osteoarthritis

- concomitant lesion of the collateral ligaments

- insufficient knowledge of the study language

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Wedge Insole 5mm

Knee Brace


Locations

Country Name City State
Austria Department of Orthopedic; Medical University of Innsbruck Innsbruck Tyrol

Sponsors (1)

Lead Sponsor Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Knee-specific questionnaires which combine an activity and a quality of life score. Two years