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
Scientific
Clinical Epidemiology Division
Dept. of Trauma and Orthopaedic Surgery
Unfalllkrankenhaus Berlin
Warener Str. 7
Berlin
12683
Germany
stengeldirk@aol.com |
Study information
Study design | Randomised active controlled parallel group trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 | 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 study start date | 01/12/2004 |
Completion date | 31/12/2005 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 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
12683
Germany
Sponsor information
Emergency Hospital, Berlin (Unfallkrankenhaus Berlin) (Germany)
Hospital/treatment centre
Hospital/treatment centre
Warener Str. 7
Berlin
12683
Germany
stengeldirk@aol.com | |
Website | http://www.ukb.de |
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 share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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 |