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Fractures, Bone clinical trials

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NCT ID: NCT00823251 Completed - Clinical trials for Orthopedic Fractures

IlluminOss Hand Fracture International Clinical Feasibility Study

Start date: December 2008
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the initial safety and technical feasibility of the IlluminOss System in the treatment of fractures of bones in the hand.

NCT ID: NCT00816998 Completed - Radius Fractures Clinical Trials

Range of Motion and Patients With Distal Radius Fractures

Start date: October 2006
Phase: N/A
Study type: Interventional

Hypothesis : Early active range of motion protocol after open reduction and internal fixation of a distal radius fracture with a volar fixed angle locking plate results in earlier return of functional motion, earlier return to work and improved functional outcomes compared delayed mobilization. Specific Aim: To compare early range of motion versus delayed motion protocol in distal radius fractures treated with open reduction and internal fixation with a volar fixed angle locking plate with respect to time to fracture union, range of motion, functional outcome measures, return to work and complications.

NCT ID: NCT00809861 Completed - Clinical trials for Distal Radius Fractures

Volar Locking Plate Versus External Fixator/Cast Fixation for the Treatment of Distal Radius Fractures

Start date: August 2008
Phase: N/A
Study type: Interventional

Aim: Osteosynthesis with locking plate/screws has become increasingly popular in recent years. It is the only treatment option which allows immediate postoperative immobilization. However, compared to conservative treatment or treatment with external fixators, locking plates are very expensive and the operation can be very challenging, even for experienced surgeons. The long-term results of all treatment modalities are equal, which has been shown in numerous studies. However, there are no evidence based studies published yet which look at short-term outcomes. The investigators do feel but do not know that patients who do not need postoperative immobilization return to work significantly earlier or are independent faster than patients whose wrists are immobilized for up to 6 weeks. If that is the case, then the higher costs and risks of the operation are justified, if not, then we have to re-evaluate our indications for using locking distal radius plates distal radius Methods: Group 1: Treatment of distal radius fractures with either volar or dorsal locking plates. No fixation postoperatively, immediate ROM (range of motion) exercises and usage of the wrist in activities of daily life (ADL) allowed. Radiological and clinical controls 2 weeks, 6 weeks and 12 weeks postoperatively. Endpoints are time to return to work / return to independency (in older people), ROM; Grip strength (with Jamar Dynamometer). Outcome scores are DASH (Disability of Arm, Shoulder and Hand Score)and PRWE (Patient related wrist evaluation). Group 2 Treatment of distal radius fractures with either an external fixator +/- K-wires or with K-wires and forearm cast or by cast alone. Main issue is that the wrist is immobilized for a period of 6 weeks. Radiological and clinical controls 2 weeks, 6 weeks and 12 weeks postoperatively. Endpoints are time to return to work / return to independency (in older people), ROM; Grip strength (with Jamar Dynamometer). Outcome scores are DASH and PRWE. Both plating and external fixation / cast fixation are standard and accepted treatment modalities for distal radius fractures. A power analysis indicated that a total sample size of 52 patients randomized equally (1:1) to each treatment arm without any blocking or stratification would provide 80 % statistical power (alpha = .05, beta = .20) to detect a 20% difference in mean DASH and PRWE scores.

NCT ID: NCT00800124 Completed - Hip Fracture Clinical Trials

Study on Cemented Versus Non-cemented Hemiarthroplasty in Elderly With Hip Fractures

CNC
Start date: June 2005
Phase: N/A
Study type: Interventional

The objective is to study the overall frequency and cumulative rate (during one year) of clinical morbidity (defined as any hospitalization without fatal outcome) and mortality in all consecutive patients undergoing HF surgery (pins and prosthetic implants) and compare this to the group of patients receiving prosthetic implants and further find out if there is a difference between the non-cemented and cemented groups. Between the same prosthetic groups, the investigators want to study the overall frequency of in-hospital subclinical organ damage and dysfunction of myocardium, liver and lungs, using biochemical plasma markers. Finally, the investigators want to perform perioperative cost benefit calculations and out of hospital quality of life analysis between the surgical groups.

NCT ID: NCT00798733 Completed - Sacrum Fracture Clinical Trials

Study of Sacral Fractures Using Patient Based and Objective Outcomes

Start date: October 2008
Phase:
Study type: Observational

The purpose of this study is to define the outcomes, both patient based and radiographic, for sacral fractures based upon injury pattern, displacement, and treatment. This will aid the orthopaedist in determining the best course for those patients with mild to moderate displacement. Multiple centers will be included and not asked to change their protocols for management. The prospective evaluation will gather specific data points on mechanism of injury, displacements, position at union, and disease specific and general health outcomes.

NCT ID: NCT00793637 Completed - Femur Fracture Clinical Trials

Evaluation of Handling and Possible Complications Related to the Newly Developed Angular Stable Locking System (ASLS)

ASLS-Pre
Start date: August 2008
Phase:
Study type: Observational

In many cases, the existing locking bolts and screws in intramedullary nails do not provide sufficient stability. Due to the play between screw and nail, the reduction can be lost and the instability can result in malunions, nonunions, or pseudoarthrosis. Consequently, secondary angular fracture dislocation (defined as a difference of the angle of 10° or more from the post-operative to the follow-up x-rays) can be observed in approximately 30% of patients after conventional intramedullary nailing of proximal third tibial fractures and in approximately 0-2% in patients with distal third tibial fractures. Therefore, an Angular Stable Locking System for Intramedullary Nails (ASLS) was developed to reduce the risk of secondary loss of reduction by providing axial and angular stability. ASLS provides angular stable fixation between nails and screws with resorbable sleeves used as dowels in the nail locking holes. The present study evaluates the handling of ASLS and the surgeon's compliance as well as any complications occurring during the baseline and the follow-up period in patients with proximal and distal tibial, femoral and humeral fractures treated with intramedullary nails. Furthermore, the relationship of any occurred complications to ASLS will be assessed.

NCT ID: NCT00779948 Completed - Clinical trials for Femoral Neck Fracture

Dynamic Internal Fixation of Femoral Neck Fractures

DIFINE
Start date: December 2008
Phase: N/A
Study type: Observational

Evaluation of dynamic Plate-Screw-Systems for internal fixation after femoral neck fractures. Open Registry for Comparison of 1-screw-systems (DHS) with multi-screw-system Targon FN.

NCT ID: NCT00774618 Completed - Rib Fracture Clinical Trials

Evaluation of Surgical Treatment on Pain and Disability for Chronic, Non-healing Rib Fracture

Start date: October 2008
Phase: Phase 4
Study type: Interventional

Individuals with non-healing rib fractures may experience significant pain and disability. This is called rib fracture non-union, an unusual problem and one that most physicians have little experience with. The investigators hypothesize that surgical repair of rib fracture non-union is clinically efficacious and safe in 6 month follow-up. The objective of this study is to evaluate how repairing non-healing rib fractures affects pain and disability.

NCT ID: NCT00772850 Completed - Humeral Fractures Clinical Trials

Rotator Cuff Injury in Antegrade Locked Nailing for Humeral Fractures

SRC
Start date: October 2008
Phase: N/A
Study type: Observational

The purpose of this study is to investigate the potential insults of rotator cuff muscle and the functional recovery of upper extremity function after antegrade nailing of humeral fractures.

NCT ID: NCT00767585 Completed - Breast Cancer Clinical Trials

An Open Label Non-Interventional Evaluation of the Effect of Adjuvant Hormonal Treatment of Postmenopausal Women Wih Early Breast Cancer With Aromatase Inhibitors on Bone Mineral Density and Bone Fracture Rate in Daily Practice

Start date: August 2008
Phase: N/A
Study type: Observational

The aim of this study is to determine the effect of aromatase inhibitors therapy on bone mineral density and compare it to the effects of tamoxifen and no hormonal therapy.