Forearm Pronation Strength RecoveryNCT02595229
Pronator Quadratus Repair After Volar Plating of Distal Radius Fractures
A study testing Pronator quadratus repair in people with Forearm Pronation Strength Recovery, run by Technical University of Munich.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Forearm Pronation Strength Recovery
- What is being tested?
- Pronator quadratus repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- concomitant fractures of the affected upper extremity
- intra-articular distal radius fractures ( type C)
- concomitant neurovascular injuries
- preexisting neurological illnesses
- initial external fixation
About this study
Official title: Pronator Quadratus Repair After Volar Plating of Distal Radius Fractures or Not? - Results of a Prospective Randomized Trial
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)
Read the 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)
- Conditions
- Forearm Pronation Strength Recovery
- Being tested
- Pronator quadratus repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pronator quadratus repairProcedure or surgery
Suturing of the pronator quadratus muscle
| Study group | Role | What they receive |
|---|---|---|
| PQ (Pronator quadraus) repair | Active comparator | Following volar plate osteosynthesis the pronator quadratus muscle is sutured with 3 to 5 U-shaped stitches using a polyfilament absorbable synthetic suture. Receives: Procedure: Pronator quadratus repair |
| No PQ repair | No intervention | Following volar plate osteosynthesis the pronator quadratus muscle is placed in its anatomical position without suture repair. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isometric forearm pronation strength (N)
Measurement of the isometric forearm pronation strength (N) using the IsoForce-Control EVO 2 dynamometer (MDS AG, Oberburg, Switzerland)
Measured: 6 weeks postoperative
Isometric forearm pronation strength (N)
Measurement of the isometric forearm pronation strength (N) using the IsoForce-Control EVO 2 dynamometer (MDS AG, Oberburg, Switzerland)
Measured: 12 weeks postoperative
Secondary outcomes (8)
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)
Measured: 6 weeks postoperative
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)
Measured: 12 weeks postoperative
Visual analogue scale (VAS)
Measurement of the pain level
Measured: 6 weeks postoperative
Visual analogue scale (VAS)
Measurement of the pain level
Measured: 12 weeks postoperative
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))
Measured: 6 weeks postoperative
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))
Measured: 12 weeks postoperative
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)
Measured: 6 weeks postoperative
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)
Measured: 12 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startMay 2010
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Forearm Pronation Strength RecoveryStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastian Siebenlist, MD, Principal investigator, Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar, Technische Universität MünchenGunther Sandmann, MD, Principal investigator, Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar, Technische Universität München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02595229
- Sponsor's protocol ID
- 2759/10
- Status last verified
- Nov 2015
- First submitted
- 25 Oct 2015
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26607745
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pronator Quadratus Repair After Volar Plating of Distal Radius Fractures or Not? - Results of a Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT02595229
- Acronym / sponsor ID
- 2759/10
- Conditions
- Forearm Pronation Strength Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 3 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PQ (Pronator quadraus) repair | Active comparator | Procedure: Pronator quadratus repairFollowing volar plate osteosynthesis the pronator quadratus muscle is sutured with 3 to 5 U-shaped stitches using a polyfilament absorbable synthetic suture. |
| No PQ repair | No intervention | –Following volar plate osteosynthesis the pronator quadratus muscle is placed in its anatomical position without suture repair. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- concomitant fractures of the affected upper extremity
- intra-articular distal radius fractures ( type C)
- concomitant neurovascular injuries
- preexisting neurological illnesses
- initial external fixation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pronator quadratus repairSuturing of the pronator quadratus muscle | Procedure or surgery | PQ (Pronator quadraus) repair |
Primary outcome
Isometric forearm pronation strength (N)
Time frame: 6 weeks postoperative
Measurement of the isometric forearm pronation strength (N) using the IsoForce-Control EVO 2 dynamometer (MDS AG, Oberburg, Switzerland)
Isometric forearm pronation strength (N)
Time frame: 12 weeks postoperative
Measurement of the isometric forearm pronation strength (N) using the IsoForce-Control EVO 2 dynamometer (MDS AG, Oberburg, Switzerland)
8 secondary outcomes
Quick DASH Score (Patient-reported evaluation score for disabilities of the arm, shoulder and hand)
Time frame: 6 weeks postoperative
Quick DASH Score (Patient-reported evaluation score for disabilities of the arm, shoulder and hand)
Time frame: 12 weeks postoperative
Visual analogue scale (VAS)
Time frame: 6 weeks postoperative
Visual analogue scale (VAS)
Time frame: 12 weeks postoperative
Mayo-Wrist-Score (Physician-based evaluation score of the wrist function)
Time frame: 6 weeks postoperative
Mayo-Wrist-Score (Physician-based evaluation score of the wrist function)
Time frame: 12 weeks postoperative
Assessment of the bilateral wrist motion (AO neutral-0-method)
Time frame: 6 weeks postoperative
Assessment of the bilateral wrist motion (AO neutral-0-method)
Time frame: 12 weeks postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
- Derived from this study: PubMed 26607745Haberle 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian Siebenlist, MD principal investigator
Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar, Technische Universität München
Gunther Sandmann, MD principal investigator
Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar, Technische Universität München
Questions about this trial
What is this clinical trial studying?
A study testing Pronator quadratus repair in people with Forearm Pronation Strength Recovery, run by Technical University of Munich.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isometric forearm pronation strength (N) (time frame: 6 weeks postoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02595229, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2015.