The Influence of Wedge Insoles After Partial Meniscectomy
Effect of Orthotic Devices in the Recovery After Partial Meniscectomy
2 other identifiers
interventional
63
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2014
Longer than P75 for not_applicable
1 active site
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
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 12, 2014
CompletedFirst Posted
Study publicly available on registry
July 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedMarch 23, 2018
March 1, 2018
3.8 years
July 12, 2014
March 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Knee-specific questionnaires which combine an activity and a quality of life score.
Two years
Study Arms (3)
No specific treatment
NO INTERVENTIONNo specific treatment after partial meniscectomy
Wedge Insole with 5mm wedge angel
OTHERParticipants wear a wedge insole after partial meniscectomy
Knee Brace
OTHERParticipants wear a knee brace after partial meniscectomy
Interventions
Eligibility Criteria
You may qualify if:
- full leg x-ray to measure the leg axis
- undersigned Informed Consent Form
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Orthopedic; Medical University of Innsbruck
Innsbruck, Tyrol, 6020, Austria
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Liebensteiner, Priv. Doz. Mag. Dr. PhD
Department of Orthopedic, Medical University of Innsbruck
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, MSc, PhD
Study Record Dates
First Submitted
July 12, 2014
First Posted
July 15, 2014
Study Start
March 1, 2014
Primary Completion
December 1, 2017
Study Completion
January 1, 2018
Last Updated
March 23, 2018
Record last verified: 2018-03