Gait Analysis Following Knee Viscosupplementation

NCT ID: NCT03636971

Last Updated: 2018-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-01

Study Completion Date

2017-01-01

Brief Summary

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This is a pilot, double-blind, randomised trial that investigates which gait parameters are more sensitive following a single bolus injection of hyaluronic acid with mannitol, hyaluronic acid with sorbitol, or saline placebo for knee osteoarthritis. Outcome measures are gait analysis through a inertial sensors (Physilog), Knee Society Score (KSS), University of California Los Angeles (UCLA) activity-scale and EuroQol 5Dimensions. Follow-up will be of 4 weeks.

Detailed Description

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Conditions

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Gait Knee Osteoarthritis Injection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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hyaluronic acid with mannitol

Group Type EXPERIMENTAL

hyaluronic acid with mannitol

Intervention Type DRUG

single shot injection (Ostenil Plus®, TRB Chemedica SA, CH, 1800kD)

hyaluronic acid with sorbitol

Group Type EXPERIMENTAL

hyaluronic acid with sorbitol

Intervention Type DRUG

single shot injection (Synolis®, Gebro-Pharma AG, CH, 2000 kD)

saline

Group Type ACTIVE_COMPARATOR

Placebos

Intervention Type DRUG

single shot injection of saline, same volume

Interventions

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hyaluronic acid with mannitol

single shot injection (Ostenil Plus®, TRB Chemedica SA, CH, 1800kD)

Intervention Type DRUG

hyaluronic acid with sorbitol

single shot injection (Synolis®, Gebro-Pharma AG, CH, 2000 kD)

Intervention Type DRUG

Placebos

single shot injection of saline, same volume

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* diagnosis of primary knee OA Ahlbäck II-III and signed consent forms.

Exclusion Criteria

* recent history of infection, diabetes, neurological impairment, chronic venous or lymphatic stasis, pain medication of level 2 or 3, psychiatric conditions, contraindications for HA joint injection and previous HA or steroid injections in the last six months.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigitte Jolles, MD

OTHER

Sponsor Role lead

Responsible Party

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Brigitte Jolles, MD

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Brigitte Brigitte

Role: STUDY_CHAIR

CHUV

Locations

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CHUV - Hopital Orthopedique

Lausanne, Canton of Vaud, Switzerland

Site Status

Countries

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Switzerland

References

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Pereira LC, Schweizer C, Moufarrij S, Krahenbuhl SM, Favre J, Gremion G, Applegate LA, Jolles BM. Gait analysis following single-shot hyaluronic acid supplementation: a pilot randomized double-blinded controlled trial. Pilot Feasibility Stud. 2019 Apr 22;5:56. doi: 10.1186/s40814-019-0443-4. eCollection 2019.

Reference Type DERIVED
PMID: 31024734 (View on PubMed)

Other Identifiers

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CER-VD No 273/13

Identifier Type: -

Identifier Source: org_study_id

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