Pronator Quadratus Repair After Volar Plating of Distal Radius Fractures

NCT ID: NCT02595229

Last Updated: 2015-11-03

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

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-03-31

Brief Summary

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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

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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)

Conditions

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Forearm Pronation Strength Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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PQ (Pronator quadraus) repair

Following volar plate osteosynthesis the pronator quadratus muscle is sutured with 3 to 5 U-shaped stitches using a polyfilament absorbable synthetic suture.

Group Type ACTIVE_COMPARATOR

Pronator quadratus repair

Intervention Type PROCEDURE

Suturing of the pronator quadratus muscle

No PQ repair

Following volar plate osteosynthesis the pronator quadratus muscle is placed in its anatomical position without suture repair.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pronator quadratus repair

Suturing of the pronator quadratus muscle

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sebastian Siebenlist, MD

Role: PRINCIPAL_INVESTIGATOR

Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar, Technische Universität München

Gunther Sandmann, MD

Role: PRINCIPAL_INVESTIGATOR

Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar, Technische Universität München

References

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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.

Reference Type DERIVED
PMID: 26607745 (View on PubMed)

Other Identifiers

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2759/10

Identifier Type: -

Identifier Source: org_study_id

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