Contact information
Type
Scientific
Primary contact
Dr Dirk Stengel
ORCID ID
Contact details
Clinical Epidemiology Division
Dept. of Trauma and Orthopaedic Surgery
Unfalllkrankenhaus Berlin
Warener Str. 7
Berlin
12683
Germany
stengeldirk@aol.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
SPOT
Study hypothesis
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
Not provided at time of registration
Study design
Randomised active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
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
Secondary outcome measures
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
Overall trial start date
01/12/2004
Overall trial end date
31/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
54
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/12/2004
Recruitment end date
31/12/2005
Locations
Countries of recruitment
Germany
Trial participating centre
Clinical Epidemiology Division
Berlin
12683
Germany
Sponsor information
Organisation
Emergency Hospital, Berlin (Unfallkrankenhaus Berlin) (Germany)
Sponsor details
Warener Str. 7
Berlin
12683
Germany
stengeldirk@aol.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
No sponsoring by third parties
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2005 protocol in http://www.ncbi.nlm.nih.gov/pubmed/15723704
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19483077
Publication citations
-
Protocol
Stengel D, Matthes G, Seifert J, Tober V, Mutze S, Rademacher G, Ekkernkamp A, Bauwens K, Wich M, Casper D, , Resorbable screws versus pins for optimal transplant fixation (SPOT) in anterior cruciate ligament replacement with autologous hamstring grafts: rationale and design of a randomized, controlled, patient and investigator blinded trial [ISRCTN17384369]., BMC Surg, 2005, 5, 1, doi: 10.1186/1471-2482-5-1.
-
Results
Stengel D, Casper D, Bauwens K, Ekkernkamp A, Wich M, Bioresorbable pins and interference screws for fixation of hamstring tendon grafts in anterior cruciate ligament reconstruction surgery: a randomized controlled trial., Am J Sports Med, 2009, 37, 9, 1692-1698, doi: 10.1177/0363546509333008.