Forearm Pronation Strength Recovery Clinical Trial
Official title:
Pronator Quadratus Repair After Volar Plating of Distal Radius Fractures or Not? - Results of a Prospective Randomized Trial
| Verified date | November 2015 |
| Source | Technische Universität München |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Ethics Commission |
| Study type | Interventional |
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)
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | March 2013 |
| Est. primary completion date | March 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Technische Universität München |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Isometric forearm pronation strength (N) | Measurement of the isometric forearm pronation strength (N) using the IsoForce-Control EVO 2 dynamometer (MDS AG, Oberburg, Switzerland) | 6 weeks postoperative | No |
| Primary | Isometric forearm pronation strength (N) | Measurement of the isometric forearm pronation strength (N) using the IsoForce-Control EVO 2 dynamometer (MDS AG, Oberburg, Switzerland) | 12 weeks postoperative | No |
| Secondary | 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) | 6 weeks postoperative | No |
| Secondary | 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) | 12 weeks postoperative | No |
| Secondary | Visual analogue scale (VAS) | Measurement of the pain level | 6 weeks postoperative | No |
| Secondary | Visual analogue scale (VAS) | Measurement of the pain level | 12 weeks postoperative | No |
| Secondary | 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)) | 6 weeks postoperative | No |
| Secondary | 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)) | 12 weeks postoperative | No |
| Secondary | 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) | 6 weeks postoperative | No |
| Secondary | 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) | 12 weeks postoperative | No |