Screws versus Pins for Optimal Transplant fixation in anterior cruciate ligament replacement surgery

ISRCTN	ISRCTN17384369
DOI	https://doi.org/10.1186/ISRCTN17384369
Protocol serial number	N/A
Sponsor	Emergency Hospital, Berlin (Unfallkrankenhaus Berlin) (Germany)
Funder	No sponsoring by third parties

Submission date: 29/11/2004
Registration date: 06/01/2005
Last edited: 03/09/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Dirk Stengel
Scientific

Clinical Epidemiology Division
Dept. of Trauma and Orthopaedic Surgery
Unfalllkrankenhaus Berlin
Warener Str. 7
Berlin
12683
Germany

Email	stengeldirk@aol.com

Study information

Primary study design	Interventional
Study design	Randomised active controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	SPOT
Study objectives	Added 13/08/09: The RigidFix® system preserves graft tension gained during surgery, and leads to lower KT-1000 arthrometer side-to-side differences than the BioCryl® screw after six months of follow-up. As of 13/08/09 this record has been extensively updated. All updates appear in the relevant field with the above update date.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Reconstructive surgery for anterior cruciate ligament (ACL) deficiency
Intervention	Patients will undergo standardised, arthroscopic ACL replacement by four-stranded hamstring tendon grafts. During surgery, participants will be randomised to transplant fixation by resorbable poly-L-lactide pins (experimental group) or poly-L-lactide/hydroxyapatite screws (control group). No other changes will apply in the treatment protocol. We will compare the residual anterior knee laxity at 3- and 6- months-follow-up between both methods.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Added 13/08/09 Side-to-side (repaired to healthy knee) difference in anterior translation as measured by the KT-1000 arthrometer at a defined load (89 N) six months after surgery
Key secondary outcome measure(s)	Added 13/08/09: 1. Generic and disease-specific measures of quality of life evaluated by: 1.1. Lysholm scale 1.2. Tegner score 1.3. International Knee Documentation Committee evaluation form (IKDC) German translation 2. Magnetic resonance imaging morphology of transplants and devices
Completion date	31/12/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	54
Key inclusion criteria	Female and male patients >18 years with closed tibial metaphyses, a first event of a unilateral ACL rupture, proven by arthroscopy or magnetic resonance imaging (MRI) scanning, scheduled for ACL replacement surgery.
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/12/2004
Date of final enrolment	31/12/2005

Locations

Countries of recruitment

Germany

Study participating centre

Clinical Epidemiology Division

Berlin
12683
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2009		Yes	No
Protocol article	protocol	21/02/2005		Yes	No