chronic elbow instability
Conditions
Interventions
artificial ligament group:Ligament reconstruction using the Boxloop method for artificial ligaments with LARS
autologous ligament control group:Ligament reconstruction using the autologous ligament with the Boxloop method
Sponsors
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 66 Years
Inclusion criteria
Inclusion criteria: Adults (aged =18 years) with chronic persistent instability of the lateral and medial collateral ligament complex of the elbow. " Chronic" refers to instability symptoms that have persisted for more than 3 months since the initial injury (or any acute treatment) without adequate relief. Eligible patients generally have a history of elbow dislocation or fracture dislocation (e.g., ‘terrible triad’ injury or other complex injury) and clinical and radiographic evidence of multidirectional instability (instability under valgus and/or varus stress). We require persistent instability and dysfunction after appropriate conservative treatment (e.g., bracing and physical therapy) or failed repair. New chronic cases and cases with previous ligament surgery failure (but without previous use of synthetic grafts) can be included. Patients must be medically fit for surgery and able to cooperate with postoperative rehabilitation and follow-up.
Exclusion criteria
Exclusion criteria: 1. Acute injuries: Patients with acute or subacute (<3 months after injury) elbow instability will be excluded, as acute cases usually require repair or a shorter period of immobilization and may not require reconstruction. 2. Isolated unilateral instability: Patients with isolated instability on one side only (pure medial or pure lateral) will be excluded, as the Boxer Ring is designed for joint ligament insufficiency. These cases can be treated with single ligament reconstruction and are therefore not the focus of this trial. 3. Severe arthritic lesions or joint destruction: Patients will be excluded if they have advanced post-traumatic elbow osteoarthritis or irreparable bone defects that can be better repaired with elbow arthroplasty or an intra-articular stabilizer. Preoperative X-rays/CT will be used to assess arthritis; patients with Kellgren-Lawrence grade 3–4 lesions or significant joint incongruity will be excluded. 4. Previous use of synthetic ligaments or allografts: Patients with previous surgery involving synthetic ligaments or allograft reconstruction will be excluded, as these conditions would confound comparative results (as our focus is primary reconstruction with autografts and LARS). 5. Active infection: Any active infection of the elbow (septic arthritis or chronic osteomyelitis) or evidence of a systemic infection is a contraindication to elective ligament reconstruction – such patients will be treated appropriately and not enrolled. 6. Nerve damage: Patients with irreversible nerve palsy around the affected elbow (e.g. complete ulnar or radial nerve palsy) resulting in loss of limb function and not related to instability, as outcome measures are not solely attributable to ligament reconstruction. (Note: Patients with transient or mild nerve palsy with a good chance of recovery may be included, and prophylactic ulnar nerve transposition will be performed as needed during surgery, but those with permanent functional deficits will be excluded). 7. Connective tissue diseases: We will exclude patients with systemic hyperlaxity (e.g., Ehlers-Danlos syndrome) or inflammatory arthropathies (e.g., rheumatoid arthritis) that may affect healing, unless their instability is primarily posttraumatic and the other criteria are met. Mild generalized laxity (Beighton score = 4) is not excluded, as some degree of ligamentous laxity is common; indeed, hyperlaxity patients are included, as they may benefit particularly from synthetic grafts, as previously reported. 8. Uncontrolled co-morbidities: Severe diabetes, peripheral vascular disease or other conditions that would significantly impair wound healing or render the procedure high-risk would exclude patients from safety considerations. 9. Pregnancy: Pregnant women were excluded because the effect of surgery and rehabilitation on pregnancy (and vice versa) is unknown. 10. Refusal or inability to consent: Patients unable to provide informed consent or unwilling to be randomized to either treatment would not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mayo Elbow Performance Score (MEPS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Range of Motion;Strength of grip;Disability of hand, shoulder and arm score (DASH);Oxford elbow score (OES);Complication and adverse events; | — |
Countries
China
Contacts
Public ContactLu Shengdi
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed