Clinical trial NCT02595229: 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
Overall status: COMPLETED
Phase: NA
Conditions: Forearm Pronation Strength Recovery
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2015-11-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: Isometric forearm pronation strength (N)
timeFrame: 6 weeks postoperative
measure: Isometric forearm pronation strength (N)
timeFrame: 12 weeks postoperative
Secondary outcomes:
measure: Quick DASH Score (Patient-reported evaluation score for disabilities of the arm, shoulder and hand)
timeFrame: 6 weeks postoperative
measure: Quick DASH Score (Patient-reported evaluation score for disabilities of the arm, shoulder and hand)
timeFrame: 12 weeks postoperative
measure: Visual analogue scale (VAS)
timeFrame: 6 weeks postoperative
measure: Visual analogue scale (VAS)
timeFrame: 12 weeks postoperative
measure: Mayo-Wrist-Score (Physician-based evaluation score of the wrist function)
timeFrame: 6 weeks postoperative
measure: Mayo-Wrist-Score (Physician-based evaluation score of the wrist function)
timeFrame: 12 weeks postoperative
measure: Assessment of the bilateral wrist motion (AO neutral-0-method)
timeFrame: 6 weeks postoperative
measure: Assessment of the bilateral wrist motion (AO neutral-0-method)
timeFrame: 12 weeks postoperative
Other outcomes:
Locations:
Study officials:
affiliation: Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar, Technische Universität München
name: Sebastian Siebenlist, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar, Technische Universität München
name: Gunther Sandmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.