Arthroscopic vs. Open Bone Grafting for Scaphoid Delayed/Nonunion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-68
SponsorHerlev and Gentofte Hospital
About this trial
Single site, prospective, observer-blinded randomized controlled trial. Eighty-eight patients aged 18-68 years with scaphoid delayed/non-union, will be randomized, 1:1, to either open iliac crest cancellous graft reconstruction or arthroscopic assisted distal radius cancellous chips graft reconstruction. All Danish citizens, referred to the orthopedic department, Copenhagen University Hospital in Gentofte with scaphoid delayed/nonunion will be offered participation in the trial. Exclusion criteria are: Associated fracture in the hand/upper extremity, previous failed surgical treatment for scaphoid delayed/nonunion, stage 2 SNAC or above, avascular necrosis of the proximal pole and gross deformity.
Patients are stratified for smoking habits, proximal pole involvement, and displacement of \>/\<2mm. The primary outcome is time to union, measured with repeated CT scans at 2-week intervals from 6 to 16 weeks postoperatively. Secondary outcomes are Quick disabilities of the Arm, Shoulder and Hand (Q-DASH), Visual Analogue scale (VAS), donor site morbidity, union rate, restoration of scaphoid deformity, range of motion, key-pinch, grip strength, EQ5D-5L, patient satisfaction, complications, and revision surgery. Patients are examined before the operation and 1.5, 3, 6, 12 and 24 month after the operation. Online follow-up 5 and 10 years after surgery are performed.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18-68 years.
A scaphoid fracture without healing 2-6 months since fracture (delayed union) for cases with either displacement >1mm or comminution and failed non-operative treatment.
Scaphoid fracture without healing >6 months since fracture (non-union) regardless of displacement, comminution and if previous non-operative treatment has been tried.
ASA 1-3.
Disqualifiers
Open fractures
Associated trans-scaphoid perilunate dislocation.
Associated fracture in the hand/upper extremity.
Previous failed surgical treatment for scaphoid delayed/non-union.
Trial design
Design model
Parallel
Treatments tested in this trial
Graft reconstruction and internal fixation with compression screw
Procedure/SurgeryPatients suffering from scaphoid nonunion are treated surgically by debridement, graft reconstruction and internal fixation with compression screw
Treatment groups
88 Participants
are divided into 2 treatment groupsGroup A: Arthroscopic assisted Cancellous chips graft reconstructionExperimental treatment 1 intervention
Group B: Open cancellous graft reconstructionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time to Union
Assessed with CT-scans. Union is proclaimed if at least 50% bone bridging is recorded together with absence of pain in the clinical examination
Time frame
6-16 weeks postoperative in 2 weeks intervals. If unions is not achieved a CT will be made 26 weeks postoperatively. If union is not achieved at that point, the patient will be presented for another treatment modalitySecondary outcomes
1
The Quick Disability of the Arm, Shoulder, and Hand (Q-DASH)
Q Dash is a patient-reported survey. It is a subset of 11 items from the 30-item DASH questions that assess difficulties with specific tasks: 5 concerning symptoms, 4 on social function, and 1 on work function, sleep, and confidence. The score ranges from 0-100 and the higher score reflects disabilities. The MCID has been defined as 10.8 (range, 5-15) for comparable patients.
Time frame
Preoperatively, 1.5 md, 3md, 6md, 12md, 24md, 60md, and 120 months postoperative2
Union rate
Assessed with CT-scans
Time frame
6-16 weeks postoperative. If unions is not achieved a CT will be made 26 weeks postoperatively3
Correction of deformity
The Height length ratio (HLR) and dorsal cortical angle (DCA) are found to be the most reliable measurements to describe angulation. The height-length ratio is calculated by dividing the scaphoid height by length.
Time frame
Before surgery compared to CT-scan with >50% bone bridging.4
Pain (VAS)
Pain at rest and activity is recorded on a visual analogue scale (VAS), ranging from 0-10, with 10 reflecting the worst and 0 representing no pain in the wrist.
Time frame
Preoperatively, 1.5, 3, 6, 12, 24, 60, and 120 months postoperativeOther outcomes
1
Patient satisfaction
is evaluated with the following question: What is the function of your hand today, compared to before surgery? With the following answer options: (1) disaster, (2) much worse, (3) slightly worse, (4) unchanged, (5) slightly better, (6) much better, (7) recovered. Secondary, for future research perspective patients are asked: When you consider the following parameters: The activities you can carry out in daily life, your pain, your function of the hand, do you think your current situation is satisfactory? (yes/no).
Time frame
Preoperatively, 1.5, 3, 6, 12, 24, 60, and 120 months postoperative2
EQ5D-5L
will be used to estimate the threshold for acceptable cost-utility ratio - the threshold for how much health care providers will pay for an extra quality-adjusted life year (QALY). The cost utility of the Arthroscopic- and open technique will be compared. A cost model will be defined from patient data, clinical records, and unit costs from the Danish health care system. Length of hospital stay, discharge, pain medication usage and readmission will be recorded.
Time frame
Baseline and 2-year follow up scores will be compared3
Complications and secondary surgery
We will record all complications related to the operative treatment (Tendon-, ligament-, nerve- or arterial injury, infection, complex regional pain syndrome, hematoma, or hardware failure). Reoperations, defined as revision surgery and secondary surgery due to no union will be noted.
Time frame
Preoperatively, 1.5, 3, 6, 12 and 24 months postoperativeSponsors and contacts
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Source ClinicalTrials.gov