Pronator Quadratus Repair After Volar Plating of Distal Radius Fractures
Primary Purpose
Forearm Pronation Strength Recovery
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pronator quadratus repair
Sponsored by
About this trial
This is an interventional treatment trial for Forearm Pronation Strength Recovery
Eligibility Criteria
Inclusion Criteria:
- isolated, closed fractures of the distal radius
- fractures type A2 to B2 according to the AO fracture classification system
- primary volar locking plate osteosynthesis within 7 days after trauma
Exclusion Criteria:
- concomitant fractures of the affected upper extremity
- intra-articular distal radius fractures ( type C)
- concomitant neurovascular injuries
- preexisting neurological illnesses
- initial external fixation
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
PQ (Pronator quadraus) repair
No PQ repair
Arm Description
Following volar plate osteosynthesis the pronator quadratus muscle is sutured with 3 to 5 U-shaped stitches using a polyfilament absorbable synthetic suture.
Following volar plate osteosynthesis the pronator quadratus muscle is placed in its anatomical position without suture repair.
Outcomes
Primary Outcome Measures
Isometric forearm pronation strength (N)
Measurement of the isometric forearm pronation strength (N) using the IsoForce-Control EVO 2 dynamometer (MDS AG, Oberburg, Switzerland)
Isometric forearm pronation strength (N)
Measurement of the isometric forearm pronation strength (N) using the IsoForce-Control EVO 2 dynamometer (MDS AG, Oberburg, Switzerland)
Secondary Outcome Measures
Quick DASH Score (Patient-reported evaluation score for disabilities of the arm, shoulder and hand)
The score is assessed on the basis of a questionnaire (11 questions about disabilities in the daily life and symptoms as pain, sleeplessness, paresthesia)
Quick DASH Score (Patient-reported evaluation score for disabilities of the arm, shoulder and hand)
The score is assessed on the basis of a questionnaire (11 questions about disabilities in the daily life and symptoms as pain, sleeplessness, paresthesia)
Visual analogue scale (VAS)
Measurement of the pain level
Visual analogue scale (VAS)
Measurement of the pain level
Mayo-Wrist-Score (Physician-based evaluation score of the wrist function)
Assessment of the wrist function (grip strength, range of motion, pain intensity, functional status (return to work))
Mayo-Wrist-Score (Physician-based evaluation score of the wrist function)
Assessment of the wrist function (grip strength, range of motion, pain intensity, functional status (return to work))
Assessment of the bilateral wrist motion (AO neutral-0-method)
Measurement of the wrist motion using a goniometer, injured and uninjured hand (Pronation/ Supination, Ulnarabduction/ Radialabduction, Palmarflexion/ Dorsalextension)
Assessment of the bilateral wrist motion (AO neutral-0-method)
Measurement of the wrist motion using a goniometer, injured and uninjured hand (Pronation/ Supination, Ulnarabduction/ Radialabduction, Palmarflexion/ Dorsalextension)
Full Information
NCT ID
NCT02595229
First Posted
October 25, 2015
Last Updated
November 1, 2015
Sponsor
Technical University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT02595229
Brief Title
Pronator Quadratus Repair After Volar Plating of Distal Radius Fractures
Official Title
Pronator Quadratus Repair After Volar Plating of Distal Radius Fractures or Not? - Results of a Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Investigation of the influence of the pronator quadratus (PQ) muscle repair following volar plate fixation of distal radius fractures with regard to the forearm pronation strength. During the early recovery period of 3 months an improvement of pronation strength and functional scorings was hypothesized for the PQ repair when compared to no repair.
Randomization of the patients in two groups ( PQ repair and no repair) and follow-up examinations after 6 and 12 weeks included bilateral isometric pronation strength measurement, range of motion, the QuickDASH and the Mayo-Wrist-Score, and a visual analogue scale (VAS)
Detailed Description
Investigation of the influence of the pronator quadratus (PQ) muscle repair following volar plate fixation of distal radius fractures with special regards to the forearm pronation strength. During the early recovery period of 3 months an improvement of pronation strength and functional scorings was hypothesized for the PQ repair when compared to no repair.
Therefore the patients are randomized to group A = PQ repair and group B = no repair. Follow-up examinations after 6 and 12 weeks are scheduled included bilateral isometric pronation strength measurement, range of motion, the QuickDASH and the Mayo-Wrist-Score, and a visual analogue scale (VAS)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Forearm Pronation Strength Recovery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PQ (Pronator quadraus) repair
Arm Type
Active Comparator
Arm Description
Following volar plate osteosynthesis the pronator quadratus muscle is sutured with 3 to 5 U-shaped stitches using a polyfilament absorbable synthetic suture.
Arm Title
No PQ repair
Arm Type
No Intervention
Arm Description
Following volar plate osteosynthesis the pronator quadratus muscle is placed in its anatomical position without suture repair.
Intervention Type
Procedure
Intervention Name(s)
Pronator quadratus repair
Intervention Description
Suturing of the pronator quadratus muscle
Primary Outcome Measure Information:
Title
Isometric forearm pronation strength (N)
Description
Measurement of the isometric forearm pronation strength (N) using the IsoForce-Control EVO 2 dynamometer (MDS AG, Oberburg, Switzerland)
Time Frame
6 weeks postoperative
Title
Isometric forearm pronation strength (N)
Description
Measurement of the isometric forearm pronation strength (N) using the IsoForce-Control EVO 2 dynamometer (MDS AG, Oberburg, Switzerland)
Time Frame
12 weeks postoperative
Secondary Outcome Measure Information:
Title
Quick DASH Score (Patient-reported evaluation score for disabilities of the arm, shoulder and hand)
Description
The score is assessed on the basis of a questionnaire (11 questions about disabilities in the daily life and symptoms as pain, sleeplessness, paresthesia)
Time Frame
6 weeks postoperative
Title
Quick DASH Score (Patient-reported evaluation score for disabilities of the arm, shoulder and hand)
Description
The score is assessed on the basis of a questionnaire (11 questions about disabilities in the daily life and symptoms as pain, sleeplessness, paresthesia)
Time Frame
12 weeks postoperative
Title
Visual analogue scale (VAS)
Description
Measurement of the pain level
Time Frame
6 weeks postoperative
Title
Visual analogue scale (VAS)
Description
Measurement of the pain level
Time Frame
12 weeks postoperative
Title
Mayo-Wrist-Score (Physician-based evaluation score of the wrist function)
Description
Assessment of the wrist function (grip strength, range of motion, pain intensity, functional status (return to work))
Time Frame
6 weeks postoperative
Title
Mayo-Wrist-Score (Physician-based evaluation score of the wrist function)
Description
Assessment of the wrist function (grip strength, range of motion, pain intensity, functional status (return to work))
Time Frame
12 weeks postoperative
Title
Assessment of the bilateral wrist motion (AO neutral-0-method)
Description
Measurement of the wrist motion using a goniometer, injured and uninjured hand (Pronation/ Supination, Ulnarabduction/ Radialabduction, Palmarflexion/ Dorsalextension)
Time Frame
6 weeks postoperative
Title
Assessment of the bilateral wrist motion (AO neutral-0-method)
Description
Measurement of the wrist motion using a goniometer, injured and uninjured hand (Pronation/ Supination, Ulnarabduction/ Radialabduction, Palmarflexion/ Dorsalextension)
Time Frame
12 weeks postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
isolated, closed fractures of the distal radius
fractures type A2 to B2 according to the AO fracture classification system
primary volar locking plate osteosynthesis within 7 days after trauma
Exclusion Criteria:
concomitant fractures of the affected upper extremity
intra-articular distal radius fractures ( type C)
concomitant neurovascular injuries
preexisting neurological illnesses
initial external fixation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian Siebenlist, MD
Organizational Affiliation
Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar, Technische Universität München
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gunther Sandmann, MD
Organizational Affiliation
Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar, Technische Universität München
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
26607745
Citation
Haberle S, Sandmann GH, Deiler S, Kraus TM, Fensky F, Torsiglieri T, Rondak IC, Biberthaler P, Stockle U, Siebenlist S. Pronator quadratus repair after volar plating of distal radius fractures or not? Results of a prospective randomized trial. Eur J Med Res. 2015 Nov 25;20:93. doi: 10.1186/s40001-015-0187-4.
Results Reference
derived
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Pronator Quadratus Repair After Volar Plating of Distal Radius Fractures
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