NCT01254682

Brief Summary

The primary objective of this study is to evaluate the efficacy and safety of Ostenil application (1% hyaluronan) after arthroscopy of the wrist.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2010

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 6, 2010

Completed
Last Updated

September 28, 2011

Status Verified

September 1, 2011

Enrollment Period

2.6 years

First QC Date

November 22, 2010

Last Update Submit

September 27, 2011

Conditions

Arthroscopic Surgery

Keywords

wristjointarthroscopyhyaluronanhyaluronic acidNecessity of Arthroscopic surgery

Outcome Measures

Primary Outcomes (1)

  • Inter-group comparison of Mayo total wrist score in subjects with or without post-arthroscopic hyaluronan treatment 3 months after arthroscopic surgery.

    Mayo wrist score evaluation consisting of 4 sections: * Maximal grip strength on injured side (compared to maximal strength of contralateral side, measured by 4-point scale, ranking from '0' for minimal to '30' for maximal strength) * Range of motion (measured by 4-point scale, ranking from '0' for minimal to '20' for maximal mobility) * Pain (measured by 4-point scale, ranking from '0' for maximal to '20' for minimal pain) * Function in daily activities (measured by 4-point scale, ranking from '0' for minimal to '30' for maximal function)

    Baseline and 3 months

Secondary Outcomes (7)

  • Inter-group comparison of Mayo total wrist score in subjects with or without post-arthroscopic hyaluronan treatment.

    Measured during the 6-month duration of participation

  • Disabilities of the arm, shoulder, and hand (DASH) outcome measure

    Measured during the 6-month duration of participation

  • Grip strength

    Measured during the 6-month duration of participation

  • Visual analogue scale of pain (VAS; 100 mm)

    Measured during the 6-month duration of participation

  • Clinical Global Impression (CGI)

    Measured during the 6-month duration of participation

  • +2 more secondary outcomes

Study Arms (2)

Hyaluronic acid sodium salt (1%, 20mg/2ml)

ACTIVE COMPARATOR
Device: Ostenil

Standard arthroscopic procedure

OTHER
Procedure: Standard arthroscopic procedure

Interventions

OstenilDEVICE

Standard arthroscopy (including intra-articular injection of 5 ml scandicain (0,5%), or 5 ml bupivacain plus 5 ml suprarenin in case of post-arthroscopic treatment). Add-on treatment with Ostenil after standard arthroscopic procedure. Application twice: first injection directly after arthroscopic procedure and second injection 3 weeks post arthroscopic.

Hyaluronic acid sodium salt (1%, 20mg/2ml)
Standard arthroscopic procedurePROCEDURE

Standard arthroscopy (including intra-articular injection of 5 ml scandicain (0,5%), or 5 ml bupivacain plus 5 ml suprarenin in case of post-arthroscopic treatment) without add-on treatment.

Standard arthroscopic procedure

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients between 18 and 80 years of age
  • Minimum pain score of 2 according to modified Mayo Wrist Score
  • Patients in good general health/nutritional condition
  • Signed written informed consent

You may not qualify if:

  • Alcohol / drug abuse, drug addiction or neurotic personality disorder; patients with mental illness or suicidal tendency
  • Severe intercurrent illness (like uncontrolled diabetes mellitus or thyroid disease, carcinoma,...)
  • Fertile women without medically secured contraception(hysterectomy, sterilization, contraceptives,...)
  • Subjects having a high probability of non compliance to the study procedures according to investigator's judgement (like illiteracy, insufficient German linguistic knowledge)
  • Contraindication for the use of one of the investigational products or for the scheduled anesthesia
  • Concomitant or previous participation in a clinical trial within the last 3 months
  • Intraarticular treatment with a sodium hyaluronate-based product within the last 6 months
  • Intraarticular treatment by the use of corticoid containing substance within the last 3 months
  • Concomitant illness or injury influencing study evaluation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopädische Gemeinschaftspraxis

Straubing, Bavaria, 94315, Germany

Location

Study Officials

  • Alexander Schütz, Dr. med.

    Orthopädische Gemeinschaftspraxis, Straubing (Germany)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2010

First Posted

December 6, 2010

Study Start

January 1, 2007

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

September 28, 2011

Record last verified: 2011-09

Locations

DE(1)