Trochanteric fracture S72.10
Conditions
Interventions
Group 1: Trochanteric fracture treated with a Gamma3 nail- No intervention, observations pre-op, Post-op, 4 months, 12 months, 24 months
Sponsors
Stryker Osteosynthesis Clinical Research
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: Male and female patients. Patients of 50 years or older of age at time of surgery. Patients who understand the conditions of the International Multicentre Prospective Clinical Follow-Up Evaluation and are willing and able to participate for the length of the prescribed term of follow-up. Patients with the ability to walk prior to the accident, with or without walking aids. Patients who have given a written consent (signed the Informed Consent form).
Exclusion criteria
Exclusion criteria: Patients, who as judged by the surgeon, are reasonably unlikely to be compliant with the prescribed post-operative routine and follow-up evaluation schedule, Patients with a physical condition (e.g. severe obesity) or neuromuscular deficit that interferes with the patient’s ability to limit weight bearing or places an extreme load on the implant in the healing period. Patients with other concurrent illnesses which are likely to affect their over all outcome. Patients who have not given a written consent (signed the Informed Consent form).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12 Months Postoperative Evaluation (- 4 Weeks / + 6 Weeks): • Merle d’Aubigne Score (pain, function, mobility & range of motion for both legs) | — |
Secondary
| Measure | Time frame |
|---|---|
| Preoperative Evaluation • investigator name, patient number, hospital number, • patient hospital number, patient initials • date of hospital admission, date of birth, • gender, weight, height • smoking (duration) •date/time of injury, side of trauma, hand dominance, • trauma circumstances, support prior to accident, mobility, walking distance • general coexistent diseases, skeletal coexistent diseases fracture side & contra-lateral side • pre-operative traction used • preoperative complications • CCF fracture classification • Radiograph labeling • Merle d’Aubigne Pain & Function Score • Parker’s Mobility Score assessing Mobility • ADL-score (Zuckermann, assessing activities of daily living) Intraoperative Evaluation • investigator name, patient number, hospital number, • date of surgery, total op-time, skin to skin time, • anaesthesia type, ASA class • intraoperative blood transfusion • reduction type (open or closed) • IM shaft reaming, proximal (trochanteric) reaming • nail length, lag screw length, nail target angle, plug screw used • distal locking procedure, distal locking screw length • fluoroscopy time • intraoperative device-, instrument complications Early Post-Operative – Prior to Discharge • investigator name, patient number, hospital number, • medication details • date of discharge, discharged to, • postoperative blood transfusion • skin incision length proximal, skin incision length total • complications prior to discharge • Sahlgrenska Mobility Score assessing status of mobility • Tip-Apex-Distance (TAD) , diameter proximal nail on x-ray (magnification) • position of lag screw centre (m/l view) 4 Months Postoperative Evaluation (- 4 Weeks / + 4 Weeks) • ROM (Range of Motion) • investigator name, patient number, hospital number, Radiographs where necessary, social living conditions • date of assessment • concomitant therapy / medication • complications at assessment • Merle d’Aubigne (pain, functi | — |
Countries
Austria, Belgium, Germany, Norway, Spain
Contacts
Public ContactNils Reimers
Stryker Osteosynthesis Clinical Research
Outcome results
None listed