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

ISRCTN ISRCTN17384369
DOI https://doi.org/10.1186/ISRCTN17384369
Secondary identifying numbers N/A
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

Study designRandomised active controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymSPOT
Study objectivesAdded 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) studiedReconstructive surgery for anterior cruciate ligament (ACL) deficiency
InterventionPatients 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 typeProcedure/Surgery
Primary outcome measureAdded 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
Secondary outcome measuresAdded 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
Overall study start date01/12/2004
Completion date31/12/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants54
Key inclusion criteriaFemale 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 criteriaDoes not meet inclusion criteria
Date of first enrolment01/12/2004
Date of final enrolment31/12/2005

Locations

Countries of recruitment

  • Germany

Study participating centre

Clinical Epidemiology Division
Berlin
12683
Germany

Sponsor information

Emergency Hospital, Berlin (Unfallkrankenhaus Berlin) (Germany)
Hospital/treatment centre

Warener Str. 7
Berlin
12683
Germany

Email stengeldirk@aol.com
Website http://www.ukb.de
ROR logo "ROR" https://ror.org/011zjcv36

Funders

Funder type

Other

No sponsoring by third parties

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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