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Intramedullary Nail versus Sliding hip screw Inter-Trochanteric Evaluation (INSITE): a multicenter randomized controlled trial

Organizational Data

DRKS-ID:
DRKS00003342
Recruitment Status:
Recruiting planned
Date of registration in DRKS:
2012-01-04
Last update in DRKS:
2012-01-09
Registration type:
Prospective

Acronym/abbreviation of the study

Insite

URL of the study

No Entry

Brief summary in lay language

In patients that have sustained a hip fracture in the area of the greater trochanter, the fracture is ether treated with a nail or a plate system on a randomized basis. Results of these two groups are then evaluated regarding the resulting quality of life and surgical results.

Brief summary in scientific language

This is a multi-center, blinded, randomized controlled trial (RCT) using a parallel design to investigate the impact of Gamma3 intramedullary nails compared with sliding hip screws on quality of life, rates of revision surgery, fracture-related adverse events, and fracture healing among patients with intertrochanteric fractures.

Health condition or problem studied

ICD10:
S72.1 - Pertrochanteric fracture
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Osteosynthesis of trochanteric fracuture using an intramedullary Gamma3 nail
Arm 2:
Dynamic Hip Screw Osteosynthesis of a trochanteric fracture

Endpoints

Primary outcome:
Health related Quality of life assessed with the Euroquol 5D after 1 year
Secondary outcome:
a) Revision surgery rates at 1 Mo./ 4 Mo./ 12 Mo. b) Fracture healing rates at 1 yr. c) Fracture-related adverse events at 1 Mo./ 4 Mo./ 12 Mo. d) Health-related quality of life (HRQL), including the Parker mobility score (Mobility) at 1 Mo./ 4 Mo./ 12 Mo. and Harris Hip Score (Hip Function) at 1 Mo./ 4 Mo./ 12 Mo.

Study Design

Purpose:
Treatment
Allocation:
Randomized controlled study
Control:
  • Active control (effective treatment of control group)
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting planned
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
  • Sweden
  • United Kingdom
  • United States
Number of study centers:
Multicenter study
Recruitment location(s):
  • University medical center Dept. Trauma and Orthopaedics Lübeck

Recruitment period and number of participants

Planned study start date:
2012-02-01
Actual study start date:
No Entry
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
768
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
trochanteric fracture necessitation surgical intervention surgical intervention first 7 days after trauma informed consent by patient or guardian

Exclusion Criteria

1. Associated major injuries of the lower extremity 2. Retained hardware around the affected proximal femur. 3. Infection around the proximal femur 4. Patients with disorders of bone metabolism other than osteoporosis 5. Patients with a pathologic fracture. 6. Patients with a fracture AO Type 31-A3.

Addresses

Primary Sponsor

Stryker Osteosynthesis Clinical Research
Nils Reimers
Prof. Küntscher Strasse
24232 Schönkirchen
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
No

Contact for Scientific Queries

Universität zu Lübeck
PD Dr. Arndt P. Schulz
Ratzeburger Allee 160
23538 Lübeck
Germany
Telephone:
04515004730
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Study Nurse, UK-SH, Campus Lübeck
Sylvia Schlottau
Ratzeburger Allee 160
23568 Lübeck
Germany
Telephone:
+49-451-5004730
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Universität zu Lübeck
PD Dr. Arndt P. Schulz
Ratzeburger Allee 160
23538 Lübeck
Germany
Telephone:
04515004730
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Commercial (pharmaceutical industry, medical engineering industry, etc.)

Stryker Osteosynthesis Clinical Research
Prof. Küntscher Strasse
24232 Schönkirchen
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Med. Fakultät der Universität zu Lübeck
Ratzeburger Allee 160
23538 Lübeck
Germany
Telephone:
+49-451-5004639
Fax:
+49-451-5003026
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2011-06-07
Ethics committee number:
11-138
Vote of the Ethics Committee:
Approved
Date of the vote:
2011-10-03

Further identification numbers

Other primary registry ID:
ISRCTN96308751 - International Standard Randomised Controlled Trial Number Register
EudraCT Number:
No Entry
UTN (Universal Trial Number):
U1111-1126-6957
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry